About Nuvilex, Inc. (OTCQB: NVLX): Nuvilex, Inc. is an international biotechnology firm focused on developing and preparing to commercialize treatments for cancer, diabetes and other diseases based on the live, therapeutically valuable, encapsulated cells platform. The Company is leveraging its cancer biology and clinical oncology research experience and expertise, particularly for use in oncology treatments, in addition to initiating oncology applications of medical marijuana.
For more information visit: http://www.nuvilex.com
RESEARCH & DEVELOPMENT of NVLX
Subsidiary, Medical Marijuana Sciences, Inc., is dedicated to the development of cancer treatments based upon the well-known chemical constituents of marijuana. Nuvilex is exploring ways in which the Cell-in-a-Box(TM) technology may play a role in these efforts
NVLX LIVE-CELL ENCAPSULATION RESEARCH & DEVELOPMENT
The live-cell encapsulation technology employed by Nuvilex is a way to enclose living cells in protective “cocoons” about the size of the head of a pin - we do not encapsulate drugs, but living cells. Each capsule can enclose approximately 10,000 cells; this number can differ depending upon the size of the cells encapsulated. The cell encapsulation technology used by Nuvilex can be classified as a “platform” upon which treatments for different indications may be built.
Depending on the type of cells used, the encapsulated cells can be employed in developing treatments for serious, debilitating and even deadly diseases. Nuvilex’s primary interests in the use of the live-cell encapsulation technology are for the development of treatments for various cancers and for diabetes.
Our live-cell encapsulation differs from that done by others in that the capsules that enclose the cells are made primarily of cellulose whereas others use substances such as alginate (a seaweed derivative), agarose, or chitosan, to name three. Because of this, the capsules are very robust and can withstand various external forces and this allows them to be implanted using needles or catheters without damage. Also, because they are made principally of cellulose, the capsules are essentially bio-inert in humans, so they do not degrade even after being present in the body for over two years.
The capsules contain pores that allow essential nutrients to enter and waste products and beneficial substances produced by the encapsulated cells to leave. Therefore, the cells inside the capsules can live and function for long periods of time after implantation. However, the pores are not large enough to permit the cells to leave the capsules or large enough to allow any cells of the body’s immune system to enter the capsules and destroy the encapsulated cells.
Even after more than two years in the body, no immune or inflammatory response is caused by the capsules themselves or by the cells within the capsules. In addition, the presence of the capsules does not cause fibrous overgrowth from, or other damage to, tissues nearby or surrounding the capsules.
Cells encapsulated using our technology can be stored frozen at -80°C or lower for long periods of time and then successfully thawed for use; this also allows for shipment of encapsulated cells to distant locations. Large-scale manufacturing of encapsulated cells using our technology has already been carried out according to GMP (Good Manufacturing Practice) conditions – a necessity for ultimately attaining marketing approval from drug regulatory authorities such as the U.S. FDA and the EMEA in Europe.
Nuvilex has recently acquired worldwide exclusive rights to the live cell-encapsulation technology described above from SG Austria Pte. Ltd. for the development of treatments for any and all types of cancer. The rights to use the cancer drug-activating cells (22P1G cells) that will be part of Nuvilex’s treatment for advanced pancreatic cancer (see Pancreatic Cancer section of this website) were also acquired. The acquisition of rights to use this live-cell encapsulation technology for the development of treatments for insulin-dependent diabetes is being finalized.
NVLX PANCREATIC CANCER RESEARCH & DEVELOPMENT
According to the American cancer Society, in the US alone, approximately 45,000 new cases of pancreatic cancer are expected to be diagnosed this year and about 38,000 people are predicted to die from the disease; it is the leading cause of cancer deaths in the US and worldwide. Often pancreatic cancer is not diagnosed until it has reached an advanced stage. By this time, the cancer cannot be removed surgically, is often resistant to radiation therapy or chemotherapy, and has spread (metastasized) to other organs in the body. Because of this, the average survival of patients with advanced, inoperable pancreatic cancer is given in terms of weeks or months, not years.
To date, there has only been one anticancer drug approved (in 1997) for use by the US FDA as a single agent for the treatment of advanced pancreatic cancer, namely GEMZAR®, also known as gemcitabine. Since 2000, more than 30 pivotal (for drug marketing approval) late-phase clinical trials have been carried out in an attempt to improve upon the effectiveness of gemcitabine against advanced pancreatic cancer by adding other drugs to it. Only a very few of these trials have even been moderately successful.
One of the success stories was the combination of gemcitabine with TARCEVA® (erlotinib). In the Phase III pivotal trial of that combination, the one-year survival rate for the gemcitabine/TARCEVA® combination was 24% as compared to 17% for a gemcitabine/placebo combination. In 2005, the FDA approved the gemcitabine/TARCEVA® combination as first-line therapy for advanced, metastatic pancreatic cancer.
The results of the second successful Phase III trial of a gemcitabine-containing combination were reported in January 2013. Here, the combination of ABRAXANE® plus gemcitabine was compared to gemcitabine alone in patients with advanced pancreatic cancer. ABRAXANE® is a formulation of nanoparticle-albumin-bound paclitaxel (TAXOL®). In this trial, when compared to gemcitabine alone, the ABRAXANE®/gemcitabine combination improved both median survival and one-year survival rate by about 30% and 59%, respectively. On September 6 2013, the combination of ABRAXANE® plus gemcitabine was approved by the FDA as first-line treatment for advanced, metastatic pancreatic cancer and replaced the gemcitabine/TARCEVA® combination as the “gold standard” for the treatment of the disease
A four-drug combination known as FOLFIRINOX (5-fluorouracil, leucovorin [WELLCOVORIN®], ironotecan [CAMPTOSAR®], and oxaliplatin [ELOXATIN®] is also fairly widely used to treat advanced pancreatic cancer. But, as for gemcitabine itself, and the gemcitabine/TARCEVA® and ABRAXANE®/gemcitabine combinations, FOLFIRINOX use carries with it severe drug-related side effects.
Nuvilex’s pancreatic cancer treatment consists of the use of a proprietary cellulose-based live-cell encapsulation technology together with the long-known and widely used anticancer drug ifosfamide (IFEX®). Ifosfamide is a prodrug that must be activated to its cancer-killing form for it to be effective; this usually occurs in the liver. Ifosfamide is administered intravenously (systemically), and like all anticancer drugs given this way, can cause drug-related toxicities in organs of the body unrelated to the tumor itself. The 22P1G cells encapsulated are capable of converting ifosfamide into its cancer killing form. The cells contain high levels of activity of one of the components of the cytochrome P450 enzyme system known as CYP2B1. The cytochrome P450 enzyme system is found in the liver and is responsible for the metabolism of lipids, steroid hormones, drugs, and other toxic substances. In actual practice, the pancreatic cancer treatment consists of first implanting the capsules containing the ifosfamide-activating cells through the use of radiography and then giving ifosfamide by its usual route of administration.
In a Phase I/II open-label, prospective, single-arm clinical trial, the live-cell encapsulation/ifosfamide combination was used to treat patients with advanced, inoperable pancreatic cancer. Fifty-one patients were originally “screened” for the trial; of these, 17 were enrolled in the study. Other patients were excluded from enrollment for therapy because of previous chemotherapy, previous pancreatic surgery, poor overall health, unwillingness to participate, or death prior to the start of the trial. Of the 17 patients initially enrolled in the study, 14 were ultimately treated.
Each patient in the trial received a single implantation of approximately 300 capsules (each capsule contained approximately 10,000 ifosfamide-activating cells), except for one patient who received 250 capsules, in the blood supply to the pancreas near that organ and thus the tumor itself; this was followed by two courses of therapy with ifosfamide at one-third of the dose normally used. Capsules were implanted on day 0 of treatment. After monitoring the patients on day 1, ifosfamide administration at a dose of 1 g/m2 of body surface area occurred on day 2 as a one-hour intravenous administration for three consecutive days; this was accompanied by the administration of the uroprotectant MESNA (also known as UROMITEXAN® or MESNEX®), as is normally the case when ifosfamide is used (the dose-limiting toxicity with ifosfamide is known to be damage to the urinary tract). Administration of ifosfamide was repeated on days 25-27; except for two patients who only received the initial course of treatment with ifosfamide. In addition a “quality-of-life” questionnaire was used for all 14 patients to document the clinical benefit of the treatment.
NVLX Results obtained in the clinical trial were compared with historical data for gemcitabine and included:
-median survival time of 44 weeks (after diagnosis) with the cell encapsulation/ifosfamide treatment as compared to 28 weeks with gemcitabine;
-doubling of the one-year survival rate – 36% with our treatment vs. 18% with gemcitabine;
-tumor volume was reduced 25-50% in 4 of the 14 treated patients and remained stable in the remaining patients;
-no serious drug-related side effects with the encapsulated cell/ifosfamide treatment whereas serious and very serious side effects were reported with gemcitabine; the lack of serious side effects using our treatment is probably related to the use of “lower than normal” doses of ifosfamide;
-limited side effects and reduced cancer pain intensity led to a generally increased ‘quality of life” for the majority of patients.
In a “worst case” scenario, some clinical benefit was seen in 50% of patients and in a “best case” scenario, this number increased to 71%; none of the patients who experienced a clinical benefit required and increase in their pain medication. In addition, no deleterious effects were seen that could be attributed to the presence of the capsules or the encapsulated cells; this observation testifies to the ability of the capsules to protect the cells inside them from attack and rejection by the body’s immune system for significant periods of time.
Reports of the Phase I/II trial of the cellulose-based live-cell encapsulation/ifosfamide combination in patients with advanced, inoperable pancreatic cancer have been published in reputable, peer-reviewed, scientific journals. The journal citations for the published articles are:
1. Löhr M., Hoffmeyer A., Kröger J-C., Freund M., Hain J., Holle A., Karle P., Knöfel W.T., Liebe S., Müller P., Nizze H., Renner M., Saller R.M., Wagner T., Hauenstein K., Günzburg W.H., and Salmons B. Microencapsulated cell-mediated treatment of inoperable pancreatic carcinoma. THE LANCET, Vol. 357, p. 1591 (2001).
To view the above-cited trial report click here. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2800%2904749-8/abstract. The website in this link requires that readers register before the article can be viewed – the process is simple and free.
2. Löhr M., Kröger J-C., Hoffmeyer A., Freund M., Hain J., Holle A., Knöfel W.T., Liebe S., Nizze H., Renner M., Saller R., Müller P., Wagner T., Hauenstein K., Salmons B., and Günzburg W.H. Safety, feasibility and clinical benefit of localized chemotherapy using microencapsulated cells for inoperable pancreatic cancer in a phase I/II trial. Cancer Therapy, Vol. 1, p. 121 (2003).
To view the above-cited trial report click here. http://www.cancer-therapy.org/CT/v1/A/13%20%20L%C3%B6hr%20et%20al,%20121-131%20cop.pdf
To summarize, local implantation of encapsulated cancer prodrug-activating cells near the tumor increases the locally available amount of the activated anticancer drug directly in the pancreatic tumor. This ensures high efficacy of the anticancer drug with lower doses of that drug and thus also reduces the unpleasant and often serious side effects of the chemotherapy.
On the basis of the above positive clinical trial results, Nuvilex is making preparations for conducting a late-phase, randomized, multi-site, multinational clinical trial in which our treatment will be compared “head-to-head” with gemcitabine in patients with advanced, inoperable pancreatic cancer. Initial activities underway include the “scaling-up” of the production of ifosfamide-activating cells to ensure that sufficient numbers will be available for encapsulation to complete the trial, and the establishment of a GMP-compliant facility in which to conduct the encapsulation of the cells, as well as having the requisite equipment manufactured with which to do so. In addition, Contract Research Organizations (CROs) are being evaluated to assist in all aspects of the clinical trial.
NVLX BREAST CANCER RESEARCH & DEVELOPMENT
For 2013, the American Cancer Society estimates that more than 230,000 cases of breast cancer will be diagnosed in the US alone and more than 40,000 individuals are predicted to die from this disease; about 99% of these are females. Worldwide, breast cancer is the fifth most common cause of cancer deaths, and is second only to lung cancer in overall prevalence; more than one million new cases are diagnosed each year. After skin cancer, breast cancer is the most common of all cancers among women both in the US and worldwide. The breast cancer market (in major markets) has been predicted to be almost $ 11 billion by 2018.
From 5-10% of all breast cancers have a hereditary link, with women who have a first-degree relative with breast cancer being most at risk for developing the disease. Between 20 and 25% of hereditary breast cancers and 5-10% of all breast cancers result from mutations of the breast cancer suppressor genes BRCA1 and/or BRCA2. A particularly well-known form of breast cancer, accounting for about 20-25% of non-hereditary forms of the disease, is one in which the HER2 (human epidermal growth factor) gene is overexpressed; it is known as HER2-positive, or HER2+, breast cancer. Normally, breast cells contain two copies of the HER2 gene, but in HER2+ breast cancer cells, many more copies of the gene are present; this results in a greatly increased amount of HER2 receptors on the outside of HER2+ breast cancer cells than is normally the case. This overexpression of HER2 receptors has been exploited in the development of two blockbuster monoclonal antibody drugs, HERCEPTIN® (trastuzumab) and PERJETA® (pertuzumab); these are used in various combinations against only HER2+ breast cancer..
According to the American Cancer Society, 10 different chemotherapeutic drug combinations have been widely used for years to treat various forms of breast cancer – particularly non-HER2+ breast cancer. Of these, three can be classified as two-drug combinations, six as three-drug combinations, and one is a four-drug combination. Nine of these 10 combination chemotherapies use the anticancer drug cyclophosphamide (CYTOXAN®) as one of the components of the combination.
Cyclophosphamide is a “sister” drug to ifosfamide, the anticancer agent used in the mid-phase clinical trials in patients with advanced, inoperable pancreatic cancer that employed the Company’s cell encapsulation-based treatment. Both drugs are classified as “prodrugs” and must be activated (converted to their cancer-killing form) for them to be effective; this usually takes place in the liver. The same enzyme system in the liver activates both cyclophosphamide and ifosfamide.
Given the effectiveness of Nuvilex’s pancreatic cancer treatment in which cells capable of activating ifosfamide were encapsulated in cellulose-based microcapsules. The same ifosfamide-activating enzyme as that found normally found in the liver was genetically increased in activity in the encapsulated cells. Because ifosfamide and cyclophosphamide are activated in the same way, the same type of encapsulated cells was used in a veterinary early/mid-phase clinical trial in which dogs with spontaneously-occurring mammary tumors were treated with either cyclophosphamide alone or with the combination of encapsulated cells plus cyclophosphamide.
Spontaneously-occurring mammary tumors in dogs represent a good animal model system for the testing of anticancer drugs designed to be used against breast cancer in humans. Cyclophosphamide was chosen for the study rather than ifosfamide because it is often used to treat mammary tumors in dogs and because it is a component of most combination chemotherapy regimens used against breast cancer in humans.
In the study itself, encapsulated cyclophosphamide-activating cells were implanted into the tumors and then cyclophosphamide was administered intravenously, at its usual dose, in four treatments 2,9,22, and 29 days later. As in the pancreatic cancer clinical trials in humans, the capsules and the cells within them were well tolerated – no “safety” issues were seen. Dogs that received the cell encapsulation/cyclophosphamide combination exhibited a greater degree of tumor shrinkage than dogs that received cyclophosphamide alone.
One dog had two spontaneously-occurring mammary tumors. In that animal, encapsulated cells were implanted in only one of the tumors. The tumor that did not receive the encapsulated cells, and thus was treated with cyclophosphamide alone, shrank in size by 14% as compared to the 70% shrinkage seen with the tumor that was treated with the combination of cell encapsulation plus cyclophosphamide.
The results of this study indicate that the combination of cellulose-based live-cell encapsulation and cyclophosphamide may prove to be of significant benefit for the treatment of breast cancer in humans, by optimizing the cancer-killing activity of cyclophosphamide, when that drug is used in various combination chemotherapy regimens for the disease.
NVLX DIABETES RESEARCH & DEVELOPMENT
The International Diabetes Federation estimates that more than 370 million people worldwide have diabetes and that about 190 million remain undiagnosed. Therefore, many millions of people are subject to the debilitating, and even deadly, complications of this disease; these include heart disease, vision loss, kidney disease, and nerve damage, particularly to the feet and legs, which may ultimately necessitate amputation. The worldwide market for diabetes treatments has been projected to reach $65 billion by 2020.
Diabetes is characterized by sustained high levels of sugar (glucose) in the blood. Glucose is a source of energy for all cells in the body. Normally, the levels of glucose are regulated by insulin produced by β-cells of the Islets of Langerhans (islet cells or islets)within the pancreas.
There are two “types” of diabetes:
Type 1 Diabetes - About 5-10% of diabetics have Type 1 disease,formerly called juvenile onset diabetes because it mainly occurs in those 20 of age or younger. Here, the pancreas, having been damaged by autoantibodies, is incapable of producing insulin. As a consequence, these individuals require insulin daily given either by injection or by an insulin “pump.”
Type 2 Diabetes - The majority of diabetics have Type 2 diabetes, also known as adult onset diabetes because it is not usually diagnosed until individuals are 35 years of age or older. In Type 2 diabetes, either the pancreas produces too little insulin or the insulin produced cannot be used efficiently by the body - a phenomenon known as “insulin resistance.” Insulin resistance develops because of many factors, including genetics, obesity, increasing age, and the presence of high blood sugar for a long time. Type 2 diabetes, at least in its early stages, can be “treated” by such things as increased exercise, weight loss, and by anti-diabetic drugs, but over time, many of these individuals may also require insulin administration either with or without anti-diabetic medications.
One way to reduce diabetics’ dependence on insulin administration is through the use of pancreatic islet cell transplantation. In a ground-breaking study known as the “Edmonton Protocol,” islet cells from human cadavers were transplanted into insulin-dependent diabetics. However, cadaveric islet cell transplantations are problematic because (a) the supply of islet cells is limited and (b) potent and expensive immunosuppressive drugs must be administered for the remainder of diabetic patients’ lives or for as long as islet cell transplantations are used.
In an effort to avoid the use of islet cells from human cadavers, islet cells from pigs have been employed instead. This approach, known as xenotransplantation, has been used with alginate-encapsulated pig islets and has shown some success. However, the integrity of capsules composed of alginate have been shown to degrade with time; this allows for immune system attack on the transplanted pig islets and necessitates additional transplantations. Furthermore, drug regulatory authorities have been resistant to such interspecies transplantations of tissues in the past. Finally, the use of pig islets requires that a population of “germ-free” pigs be maintained – an expensive and problematic situation.
In a “proof-of-principle” study, cellulose-based capsules (produced in the same way as the capsules used in the pancreatic cancer clinical trials) containing live pancreatic islet cells from pigs were implanted into diabetic rats. Within a very short time, the blood glucose levels of the rats became normalized and remained that way for the 6-month duration of the study. Because of the robustness and longevity (over two years in humans in the pancreatic cancer trials done to date) of the cellulose-based capsules, no immunosuppressive drugs were necessary. Finally, when the capsules were removed from the rats at the end of the study, the cells that had been encapsulated were found to be fully viable and capable of responding to changes in glucose levels in their surroundings. This study illustrates the true platform nature of the cellulose-based live-cell encapsulation technology in developing a type of artificial pancreas.
Because of the positive results from the above proof-of-principle study, the Company plans additional expanded animal studies (longer duration, more animals) in which insulin-producing cells are encapsulated in its cellulose-based capsules. If the results from the proof-of-principle study are confirmed, this would ultimately lead to human clinical trials in diabetic individuals.
NVLX Management
Kenneth L. Waggoner has almost four decades of experience in management, business, operations and law. Mr. Waggoner started his career as an attorney in private practice. Notably he was a senior partner with Brobeck, Phleger and Harrison, named one of the top two law firms worldwide that provide services to biotechnology clients including Chiron, Amgen, Biogen Idec, Sangamo, Ligand, DepoTech and many others. He was the Managing Partner of Brobeck’s Los Angeles office. Mr. Waggoner was also a member of the Executive Committee for almost ten years and on the Policy Committee for numerous years managing Brobeck’s worldwide operations with annual revenues in excess of $750,000,000. While at Brobeck, Mr. Waggoner was the Co-Chairman of Brobeck’s world-wide Environmental Law Group.
Further highlights of Mr. Waggoner’s career include leadership and legal positions with several start-up companies during the last several years as well as working with Fortune 500 companies most of his professional career. During his tenure with Chevron, Mr. Waggoner served as the Vice President and General Counsel of its Global Downstream operations where he was responsible for the overall management of legal services to the North American, Latin American, Europe and Asian Products Companies. At Chevron he led a successful restructuring of the company’s international Legal Department following Chevron’s acquisition of Texaco.
Mr. Waggoner received his Juris Doctorate. with honors in 1973 from Loyola University School of Law in Los Angeles.
Dr. Robert F. Ryan, Chief Scientific Officer:Dr. Robert F. Ryan was named Chief Scientific Officer. Dr. Ryan has broad scientific experience in biochemistry, cell and molecular biology, human genetics, novel therapies, and basic and clinical cancer research, having received his Masters in Biochemistry, Cell and Molecular Biology at The Medical College of Georgia, studying sickle cell anemia. He received his Ph.D. in Molecular Genetics at Thomas Jefferson University characterizing DNA and RNA binding properties of zinc finger proteins. Through his extensive training, his experiences extend across the fields of aging, hemoglobinopathies, gene expression, human diseases, DNA, RNA, proteins and their interactions, stem cell research and applications, oncology, clinical protocols and therapies.
Professionally, Dr. Ryan has become a pioneer in the field of emerging biotechnology, specializing in assisting small companies with insight and bringing products to market through the rigorous FDA approval process. Since 2002, Dr. Ryan served as the Chief Executive Officer of RFR Consulting where he focused on helping businesses in the biotech industry through providing information, grant writing, business management, scientific guidance, FDA regulatory advice, advising investors, and investment acquisition opportunities. With 25 years experience including excellent training at the Wistar Institute, NIH, and NCI, he has participated in basic and clinical investigations and has published and edited research articles in several peer-reviewed journals.
http://www.nuvilex.com/management
SHARE HOLDER info: http://www.nuvilex.com/shareholder-info
NVLX International Corporate Headquarters
Nuvilex, Inc.
Meadows Corporate Park I
12510 Prosperity Blvd., Suite #310
Silver Spring, MD 20904
Phone: (877) 598-7616
Fax: (917) 595-2850
email: info@nuvilex.com
NVLX Headline Press Releases
http://finance.yahoo.com/q/h?s=NVLX+Headlines
BFLX SEC Filings
http://www.otcmarkets.com/stock/NVLX/filings
Investigate more about NVLX @ http://www.otcmarkets.com/stock/NVLX/quote for more due diligence.
$NVLX -Nuvilex, Inc. Enters Most Important Step of Phase III Trials Outside of Patient Enrollment http://finance.yahoo.com/news/nuvilex-inc-enters-most-important-124500450.html on 10.1.13
ReplyDeleteNVLX NEWS just dropped Upcoming Q4 Events Bode Well for Nuvilex Shareholders - Yahoo Finance http://finance.yahoo.com/news/upcoming-q4-events-bode-well-133000893.html
ReplyDelete$NVLX newly appointed Dr. Mark Rabe, a leading figure in the emerging medical marijuana field, earned his medical degree at Northwestern University and is certified by the American Board of Integrative Holistic Medicine (ABIHM). http://ow.ly/rw56x
ReplyDelete$NVLX Holds High Level Strategic Meetings to Solidify Company Objectives and Plans for Future Research and Development http://www.stockwatch.com/News/Item.aspx?bid=U-z10060746-U%3aNVLX-20131209&symbol=NVLX®ion=U
ReplyDelete$NVLX – excited that the company's Phase 3 clinical trials may have unofficially just started http://ow.ly/qwxpX
ReplyDeleteDuring recent NVLX meetings, particular emphasis was placed on progress in preparing for the late-phase clinical trials of Nuvilex that will use the recently acquired cellulose-based live-cell encapsulation Cell-in-a-Box™ technology as part of the treatment for those suffering from advanced, inoperable pancreatic cancer. In addition, plans for developing treatments for diabetes that use the same technology were discussed in detail. Additional points of discussion were the objectives and plans for development of treatments for cancer and other diseases using active compounds derived from marijuana and the potential role that the live-cell encapsulation technology might be able to play in such treatments.
ReplyDeletehttp://www.stockwatch.com/News/Item.aspx?bid=U-z10060746-U%3aNVLX-20131209&symbol=NVLX®ion=U
$NVLX news! Contractor, Inno Biologics, Employs Clone-Pix(TM) Technology in Cloning Cells for Future Clinical Trials
ReplyDeletehttp://www.stockwatch.com/News/Item.aspx?bid=U-z10061124-U%3aNVLX-20131211&symbol=NVLX®ion=U
$NVLX news! Acquisition of Cellulose-based Live-Cell Encapsulation Technology Positions Company as a Leader in Development of Next Generation Cancer and Diabetes Treatments
ReplyDeletehttp://www.stockwatch.com/News/Item.aspx?bid=U-by410342-U%3aNVLX-20131212&symbol=NVLX®ion=U
$NVLX more news ! Preparations for Planned Late-Phase Clinical Trials Timely in Light of Increasing Incidence of Pancreatic Cancer 12/12/13
ReplyDeletehttp://www.stockwatch.com/News/Item.aspx?bid=U-z10061125-U%3aNVLX-20131212&symbol=NVLX®ion=U
$NVLX contractor, Inno Biologics Sdn. Bhd., is using the Clone-Pix™ technology for the isolation and selection of clones preparatory to obtaining the large numbers of cells for Nuvilex's future clinical trials in advanced, inoperable pancreatic cancer.
ReplyDeleteClone-Pix™ is considered to be "state-of–the-art" technology in the cloning process. It is an instrument that allows for the automated isolation of high value clones of mammalian cells. Clone-Pix™ is now employed by more than 100 laboratories and entities throughout the world and is used by notable pharmaceutical and biotech companies such as Merck, GlaxoSmithKline, Wyeth and Genentech. By employing this technology, workflow throughout the cloning process is increased and this allows for more clones to be screened in less time than would be possible using conventional technologies.
Clone-Pix™ allows for the gentle "picking" of clones to ensure high viability of the selected clones. The "best clones" for Nuvilex's purposes will be isolated, tested and propagated to obtain the requisite numbers of cells for cellulose-based encapsulation that will ultimately form part of Nuvilex's treatment for advanced pancreatic cancer. The most desirable of the selected clones will be those that have elevated activity of the enzyme that converts the cancer prodrug ifosfamide into its cancer-killing form.
Nuvilex's Chief Scientific Officer, Dr. Robert F. Ryan commented, "Through the use of Clone-Pix™, Inno Biologics will be able to optimize the selection of the most desirable clones for Nuvilex to use in producing adequate numbers of cells for our future late-phase clinical trials as expeditiously as possible. The availability of the Clone-Pix™ technology at Inno Biologics was a significant factor in our choosing that company to conduct this very important phase of our preparations for those trials." http://www.stockwatch.com/News/Item.aspx?bid=U-z10061124-U%3aNVLX-20131211&symbol=NVLX®ion=U
$NVLX ~ Nuvilex biotechnology Introduction Video Here: https://www.youtube.com/watch?v=tgDJ7jMS8Ow
ReplyDelete$NVLX to Answer Increasing Calls for Better Pancreatic Cancer Treatment Without Gemcitabine 12/16/13 http://www.stockwatch.com/News/Item.aspx?bid=U-i1076373-U%3aNVLX-20131216&symbol=NVLX®ion=U
ReplyDelete$NVLX 10-Q received Dec 16, 2013 for period ending Oct 31, 2013 showed acquisition growth
ReplyDeletehttp://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=9661725
$NVLX subsidiary will attempt to use the Cell-in-a-Box encapsulation technology in its medical marijuana research to develop treatments for some of the most hard-to-treat cancers
ReplyDelete2013-12-18 09:00 ET - News Release
NEW YORK, NY -- (Marketwired) -- 12/18/13The executives at Nuvilex, Inc. (OTCQB: NVLX) and its subsidiary, Medical Marijuana Sciences, Inc., had to take note of recent results released in a marijuana study done by a group of researchers in Spain. The study used a type of encapsulation to inhibit brain cancer cell growth in mice. These researchers seem to be speaking Nuvilex's language with the biotech's recent acquisitions of exclusive worldwide rights to a cellulose-based live-cell encapsulation technology known as Cell-in-a-Box™ for the development of treatments for diabetes and for any and all types of cancer.
In the study, the researchers found that the local administration of microparticles loaded with the two major ingredients of marijuana, tetrahydrocannabinol (THC) and cannabidiol (CBD), reduced tumor growth in a mouse model of human glioma (brain cancer). According to the data, the anti-cancerous molecules THC and CBD used in the study were encapsulated forming microparticles that acted as the drug delivery system to the cancer in the mice.
The small spheres serve as a microparticle targeted treatment system as does the Cell-in-a-Box technology being used by Nuvilex that has undergone both human clinical trials and animal studies in an effort to develop treatments for advanced, inoperable pancreatic cancer, breast cancer, and diabetes. The researchers in the Spanish study noted that a microparticle delivery system offers the benefits of controlling drug release, improving therapeutic effects, prolonging biological activity, and decreasing administration frequency.
The study showed that when microencapsulated THC and CBD were directly administered to human glioma cancer cells grafted to mice, they decreased cell proliferation, decreased angiogenesis (the penetration of blood vessels into tumors which promote metastasis), and enhanced apoptosis (the programmed death of cells). Nuvilex has stated that its subsidiary will attempt to use the Cell-in-a-Box encapsulation technology in its medical marijuana research to develop treatments for some of the most hard-to-treat cancers.
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http://www.stockwatch.com/News/Item.aspx?bid=U-i1077187-U%3aNVLX-20131218&symbol=NVLX®ion=U
Last month $NVLX acquired the exclusive worldwide rights to use the cellulose-based live-cell encapsulation technology for the development of treatments for diabetes from SG Austria Pte. Ltd.
ReplyDeleteGood things coming imo----
Nuvilex has secured $1.5 million in funding through the sale of restricted stock to accredited investors at a fixed price of $0.15 per share, a premium to the current market price per share, to complete this acquisition. One million dollars of the funds will be used for this acquisition. The balance of the funds will be used for ongoing preparations for Nuvilex's Phase 3 clinical trials in pancreatic cancer.
Nuvilex's decision to make the acquisition stems, in large part, from the results of "proof-of-principle" studies in which cells that produce insulin were transplanted into diabetic animals. The diabetic animals had much higher than normal levels of glucose in their bloodstream and had a difficult time controlling their glucose levels, just as humans with diabetes do. In animals provided with the encapsulated cells, their blood glucose levels normalized and remained stable for the duration of one six-month study, indicating the encapsulated cells produced insulin in response to their higher than normal blood glucose levels. The cellulose-based capsules seem to have prevented the encapsulated cells from being attacked by the diabetic animals' immune systems, even in the absence of immunosuppressive drugs. Therefore, the encapsulated cells appear to have acted as an artificial or replacement pancreas.
Patricia Gruden, the Chairman and CFO of Nuvilex, commented, "On behalf of my fellow Board members, I would like to thank both Drs. Ryan and Crabtree for their countless hours of hard work in securing this potentially world-changing, cutting-edge technology. We have now secured rights to technology that has the potential to change the manner in which diabetes will be treated in the future. According to a report by Transparency Market Research, entitled 'Global Diabetes Devices Market and Diabetes Drugs Market -- Industry Scenario, Trends, Analysis, Size, Share and Forecast, 2011 - 2018,' the global diabetes market for therapeutic devices and drugs is expected to reach US $114.3 billion by 2018. Nuvilex's plan is to become the world-wide leader in this market."
The President and CEO of Nuvilex, Dr. Robert F. Ryan, stated, "We are pleased to have secured this critical financing that has now enabled us to acquire the worldwide rights for the cellulose-based, live-cell encapsulation technology for the development of diabetes treatments. This acquisition is a major step in the continuing evolution of Nuvilex as a biotechnology company focused on live-cell encapsulation for the treatment of cancer and diabetes."
http://finance.yahoo.com/news/nuvilex-completes-acquisition-exclusive-worldwide-143000742.html
$NVLX Nuvilex's Provides Progress Update on Cell Cloning Being Performed by Inno Biologics
ReplyDelete2013-12-19 09:30 ET - News Release
SILVER SPRING, Md., Dec. 19, 2013 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (OTCQB:NVLX), an international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, provided an update today on the progress made by its contractor, Inno Biologics, regarding the cloning of the cancer-prodrug ifosfamide-activating cells that form the basis for the cancer treatment and will be encapsulated as part of the development of the treatment for Nuvilex's future clinical trials in advanced pancreatic cancer.
The cells being cloned at Inno Biologics are those that are able to convert ifosfamide, an anti-cancer prodrug, into its cancer-killing form. Ultimately, the cells obtained will be encapsulated using the Cell-in-a-Box™ cellulose-based live cell encapsulation technology. Together with ifosfamide, the encapsulated cells form Nuvilex's treatment for advanced pancreatic cancer that will be used in the Company's future clinical trials.
To date, the cloning process at Inno Biologics has been going well with initial clones that have been isolated using the "State-of-the-Art" Clone-Pix™ technology that allows for optimization of the clone isolation process. The To date, the cloning process at Inno Biologics has been going well with initial clones that have been isolated using the "State-of-the-Art" Clone-Pix™ technology that allows for optimization of the clone isolation process.
In addition, a strategic planning meeting was held the week of November 24, 2013 to assess issues regarding the ongoing cloning activities. Participants included Dr. Robert F. Ryan, Nuvilex's Chief Scientific Officer, Datuk Dr. Ahmed Tasir Bin Lope Pihie, CEO of Inno Biologics, Dr. Walter H. Gunzburg, Chairman and Chief Technical Officer of Austrianova and Dr. Brian Salmons, CEO and President of Austrianova from whose company the rights to use the Cell-in-a-Box™ technology for the development of cancer treatments were acquired.
In commenting on the cloning process, Dr. Ryan stated, "We are confident with the results of the initial cloning process to this point which showed its capabilities to isolate multiple clones that were grown from single cells. This is critical as we move this project forward to insure the reproducibility of the future cancer treatments being advanced here at Nuvilex. We continue to make progress toward our goal of bringing this treatment option to clinical trials for advanced inoperable pancreatic cancer."
http://www.stockwatch.com/News/Item.aspx?bid=U-z10062059-U%3aNVLX-20131219&symbol=NVLX®ion=U
$NVLX Readies for Late-Stage Trials as NCI Seeks New Pancreatic Cancer Drug 12/20/13 http://finance.yahoo.com/news/nuvilex-readies-stage-trials-nci-160500382.html
ReplyDelete$NVLX Growing Medical Marijuana Sciences to Lead Marijuana Research Industry 1/9/14 http://finance.yahoo.com/news/nuvilex-growing-medical-marijuana-sciences-143000858.html?soc_src=mediacontentstory
ReplyDelete$NVLX news! Nuvilex Making Great Strides in Medical Marijuana Initiatives http://www.stockwatch.com/News/Item.aspx?bid=U-by410899-U%3aNVLX-20140113&symbol=NVLX®ion=U
ReplyDelete$NVLX – Must listen to interview by Dr. Gerald Crabtree Discussing Nuvilex Phase 3
ReplyDeleteTrials, Study Sites, Technology & More http://ow.ly/qkcH4
$NVLX - Nuvilex's Medical Marijuana Sciences Prepares to Enhance Industry's Research With Cell-in-a-Box(TM) http://www.stockwatch.com/News/Item.aspx?bid=U-i1081571-U%3aNVLX-20140114&symbol=NVLX®ion=U
ReplyDelete$NVLX Nuvilex is currently into its preparations for late-phase clinical trials in advanced, inoperable pancreatic cancer using Cell-in-a-Box™, and these trials will only add to the experience the company's executives will have using this technology. Given the solid team they're putting together at MMS, they will likely use that experience to enhance the medical marijuana industry's search for cures to many types of cancer. http://www.stockwatch.com/News/Item.aspx?bid=U-i1081571-U%3aNVLX-20140114&symbol=NVLX®ion=U
ReplyDelete$NVLX and Medical Marijuana Companies Keep an Eye on Florida as Crucial Swing State in Cannabis Debate http://www.stockwatch.com/News/Item.aspx?bid=U-i1082375-U%3aNVLX-20140116&symbol=NVLX®ion=U
ReplyDelete$NVLX – Check out this interview of Nuvilex Upcoming Phase 3 Trials, Study
ReplyDeleteSites, Study Protocol & More http://ow.ly/qkcH4
Nuvilex, Inc. (OTCQB: NVLX) and a host of marijuana companies are keeping a close eye on what is happening with a petition drive in Florida to get the use of medical marijuana on ballots in time for the November election. Why is Florida important? Well, for a company like Nuvilex and its medical marijuana subsidiary, Marijuana Sciences, Inc., conducting research and developing treatments using the drug are made far easier if the country moves to full acceptance, and Florida could be the domino that sets the last of the states holding out in motion.
ReplyDelete$NVLX news at the bell! Obama's Shifting Opinion Good News for Marijuana Industry and Nuvilex 1/21/14 http://www.stockwatch.com/News/Item.aspx?bid=U-i1083293-U%3aNVLX-20140121&symbol=NVLX®ion=U
ReplyDelete$NVLX expects to eventually become a leader in the industry when the company begins its work to develop treatments for hard to treat cancers using marijuana http://www.stockwatch.com/News/Item.aspx?bid=U-i1083293-U%3aNVLX-20140121&symbol=NVLX®ion=U
ReplyDelete$NVLX targeted by Catalysts in the marijuana and medical marijuana industry
ReplyDeleteBaltimore, Maryland - Goldman Small Cap Research, a stock market research firm focused on the small cap and micro cap sectors, recently published a new research update on Nuvilex Inc. (OTCQB – NVLX). In the update, senior analyst Rob Goldman outlines his latest thesis.
"A series of recent landmark events in the marijuana and medical marijuana space, along with a revaluation of biotechs, are set to serve as triggers prompting the accumulation and rise of Nuvilex’s stock back to the levels enjoyed roughly 9 months ago."
Nuvilex is a biotechnology company with the rights to a novel cellulose-based live-cell encapsulation technology, called Cell-in-a-BoxTM, that will be used as a platform upon which treatments for several types of cancer, including advanced, inoperable pancreatic cancer, and diabetes are being built. Nuvilex's treatment for pancreatic cancer involves the use of the widely used anticancer prodrug, ifosfamide, together with encapsulated live cells that convert ifosfamide into its active or "cancer-killing" form. Nuvilex's subsidiary, Medical Marijuana Sciences, Inc., is dedicated to the development of cancer treatments based upon the well-known chemical constituents of marijuana. Nuvilex is exploring ways in which the Cell-in-a-BoxTM technology may play a role in these efforts.
According to Goldman, the aforementioned triggers include a surge of interest in, and validation of, medical marijuana and the publicly traded firms that operate in the space. Catalysts cited in the research update include a tacit marijuana endorsement by President Obama, which could give a huge shot in the arm to the sector. Plus, given that Colorado’s tax revenue-generating pot shops cannot keep product on the shelves, cash-strapped states and municipalities may view a softening stance on this topic as a tangible opportunity to generate real revenue.
In addition, the swift and broad shift in support toward medical marijuana will likely be enhanced during the 2- week Super Bowl marketing period. Since the two participants hail from the states that have legalized marijuana, it is likely that proponents will flood the media with stories on the topic, placing it near the top of the talking points food chain.
Finally, Goldman notes that major moves have occurred of late in other anti-cancer stocks while biotech investors seek to find the next biotech slated to move in concert with the launch of upcoming events. With a series of milestone events ahead for the Company, investors could enjoy similar moves as these milestones are achieved, as evidenced by the achievements of its peer group and the subsequent rises in their stock prices.
$NVLX WEALTHMAKERS.COM projected fundamental full valuation of $1.90 per share
ReplyDeleteSILVER SPRING, Md., Jan. 23, 2014 (GLOBE NEWSWIRE) -- WEALTHMAKERS.COM / www.wealthmakers.com , a Wall Street research and trading firm providing unbiased statistical stock market predictions to empower investors, securities professionals and public company employees to make precise, predictive and profitable trading decisions, has issued a new research report today on Nuvilex, Inc. (OTC:NVLX). The report highlights the short term bullish pattern that has emerged, the SqueezeTrigger Price and the projected fundamental full valuation of $1.90 per share
http://www.stockwatch.com/News/Item.aspx?bid=U-z10065185-U%3aNVLX-20140123&symbol=NVLX®ion=U
Nuvilex $NVLX Partner, Austrianova Chairman and Chief Technical Officer, to Present at Phacilitate International Cell & Gene Therapy Forum 2014, January 27-29 in Washington, D.C. http://www.stockwatch.com/News/Item.aspx?bid=U-z10065366-U%3aNVLX-20140124&symbol=NVLX®ion=U
ReplyDelete$NVLX partner Austrianova will present at the international Phacilitate Cell & Gene Therapy Forum 2014 to be held in Washington, DC January 27-29, 2014
ReplyDeleteSILVER SPRING, Md., Jan. 24, 2014 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (OTCQB:NVLX), an international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that Dr. Walter H. Gunzburg, Chairman and Chief Technical Officer of Nuvilex's partner Austrianova, will present at the international Phacilitate Cell & Gene Therapy Forum 2014 to be held in Washington, DC January 27-29, 2014. Dr. Gunzburg is the co-developer of the novel proprietary and patented cell encapsulation technology that Nuvilex expects will have a profound effect on how cancers and diabetes will be treated in the future.
In his presentation, Dr. Gunzburg will present data that will explain the nature of the cellulose-based live-cell encapsulation technology known as Cell-in-a-Box™. In addition to discussing the use of this technology for the encapsulation of stem cells, Dr. Gunzburg will speak to its use as a pivotal part of Nuvilex's treatment for advanced, inoperable pancreatic cancer. Dr. Gunzburg will emphasize the results of earlier Phase 1/2 clinical trials using Nuvilex's treatment for this deadly disease. The worldwide exclusive rights to use the Cell-in-a-Box™ technology in developing treatments for pancreatic and all other forms of cancer, as well as for diabetes, were acquired by Nuvilex from SG Austria Pte. Ltd. (Austrianova) and Austrianova Singapore Pte. Ltd., respectively, in 2013.
Nuvilex's proprietary pancreatic cancer treatment consists of the combination of low doses of the well-known anti-cancer prodrug ifosfamide with ifosfamide-activating (convert ifosfamide into its "cancer-killing" form) cells that have been encapsulated using the Cell-in-a-Box™ technology. In Phase 1/2 clinical trials in patients with advanced, inoperable pancreatic cancer, Nuvilex's treatment was shown to essentially double the median survival time and percentage of one-year survivors over those seen in historical data for Gemzar® (gemcitabine), the only drug approved to date by the FDA as a single agent for the treatment of the disease. But unlike Gemzar®, Nuvilex's treatment had no serious treatment-related side effects associated with it.
The Phacilitate Cell & Gene Therapy Forum is an international three-day event held annually that focuses on business and strategic issues related to the development of cell therapies and related technologies. It is considered the world's leading strategic and partnering event globally for those in the cell and gene therapy sectors. Sponsors of, and participants in, the event include many of the world's major pharmaceutical and biotech companies. Attendees also include major decision makers from those entities, regulatory personnel and others who join to discuss advances, challenges and opportunities in cell and gene therapy.
Commenting on Dr. Gunzburg's appearance at, and participation in, next week's international Cell & Gene Therapy Forum, Nuvilex CEO and President, Kenneth L. Waggoner, commented, "Dr. Gunzburg's research and development of the cellulose-based Cell-in-a-Box™ technology may revolutionize the way many experts view how difficult-to-treat cancers will be managed in the future. We're confident that his presentation and involvement in two panel discussions will capture the imaginations of experts at the Forum. We also strongly believe that the work Dr. Gunzburg and his colleagues have already accomplished, together with research Nuvilex is carrying out itself, via its subsidiary Medical Marijuana Sciences and with potential partners, may result in a sea change in the way many deadly and debilitating diseases are approached and treated in the future."
http://www.stockwatch.com/News/Item.aspx?bid=U-z10065366-U%3aNVLX-20140124&symbol=NVLX®ion=U
$NVLX Marijuana Research and Treatments Get Closer With Banking Discussions 01/27/14 http://www.stockwatch.com/News/Item.aspx?bid=U-i1084650-U%3aNVLX-20140127&symb
ReplyDeleteol=NVLX®ion=U
$NVLX contractor, Inno Biologics Sdn. Bhd., is using the Clone-Pix™ technology for the isolation and selection of clones preparatory to obtaining the large numbers of cells for Nuvilex's future clinical trials in advanced, inoperable pancreatic cancer.
ReplyDeleteClone-Pix™ is considered to be "state-of–the-art" technology in the cloning process. It is an instrument that allows for the automated isolation of high value clones of mammalian cells. Clone-Pix™ is now employed by more than 100 laboratories and entities throughout the world and is used by notable pharmaceutical and biotech companies such as Merck, GlaxoSmithKline, Wyeth and Genentech. By employing this technology, workflow throughout the cloning process is increased and this allows for more clones to be screened in less time than would be possible using conventional technologies.
Clone-Pix™ allows for the gentle "picking" of clones to ensure high viability of the selected clones. The "best clones" for Nuvilex's purposes will be isolated, tested and propagated to obtain the requisite numbers of cells for cellulose-based encapsulation that will ultimately form part of Nuvilex's treatment for advanced pancreatic cancer. The most desirable of the selected clones will be those that have elevated activity of the enzyme that converts the cancer prodrug ifosfamide into its cancer-killing form.
$NVLX - The live-cell encapsulation technology employed by Nuvilex is a way to enclose living cells in protective “cocoons” about the size of the head of a pin - we do not encapsulate drugs, but living cells. Each capsule can enclose approximately 10,000 cells; this number can differ depending upon the size of the cells encapsulated. The cell encapsulation technology used by Nuvilex can be classified as a “platform” upon which treatments for different indications may be built.
ReplyDeleteDepending on the type of cells used, the encapsulated cells can be employed in developing treatments for serious, debilitating and even deadly diseases. Nuvilex’s primary interests in the use of the live-cell encapsulation technology are for the development of treatments for various cancers and for diabetes.
$NVLX Nuvilex Acquires 14.5% Equity Interest in Austrianova 1/30/14 http://finance.yahoo.com/news/nuvilex-nvlx-acquires-14-5-141500674.html?soc_src=mediacontentstory
ReplyDelete$NVLX worldwide exclusive rights for Nuvilex to use Austrianova's Cell-in-a-Box(TM) obligation fulfilled
ReplyDeleteSILVER SPRING, Md., Jan. 30, 2014 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (NVLX), an international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that it has received its share issuance from SGAustria Pte. Ltd. (Austrianova), who owns Austrianova Singapore Pte. Ltd. (Austrianova Singapore), that equates to a 14.5% equity interest in Austrianova.
The issuance of shares by Austrianova fulfils an obligation by Austrianova to Nuvilex that was part of the Asset Purchase Agreement between both companies pertaining to the acquisition of Bio Blue Bird AG and, with it, the worldwide exclusive rights for Nuvilex to use Austrianova's Cell-in-a-Box(TM) cellulose-based live-cell encapsulation technology for the development of treatments for all types of cancer. Nuvilex has also obtained from Austrianova Singapore the exclusive worldwide rights to use the Cell-in-a-Box(TM) technology for the development of treatments for diabetes.
Cell-in-a-Box(TM) is a patented technology whereby living cells can be encapsulated in cellulose-based, pin-head-sized, spherical capsules that are bio-inert, but have pores in their outer walls to permit nutrients to enter and nourish the cells inside them and allow waste products and beneficial substances from the cells to leave. The capsules are fully protective of the living cells inside them and can remain intact in the body over long periods of time. The capsules can be easily administered via needles or through catheters. The Cell-in-a-Box(TM) technology has shown success in the treatment of pancreatic cancer when combined with the conventional chemotherapy prodrug ifosfamide administered at much lower doses than when it is used against other cancers; as a consequence, markedly reduced drug-associated side effects were experienced by the patients.
The Cell-in-a-Box(TM) technology was developed and matured under the aegis of Professor Walter H. Gunzburg, Chairman and Chief Technical Officer of Austrianova Singapore, and Dr. Brian Salmons, CEO and President of Austrianova Singapore. Over the past several years, an excellent relationship has developed among Professor Gunzburg, Dr. Salmons and Dr. Robert F. Ryan, Nuvilex's Chief Scientific Officer. Nuvilex believes that this fulfilment of the terms of the Asset Purchase Agreement will advance even further the cooperation and collaboration that has developed between the Austrianova companies and Nuvilex.
Kenneth L. Waggoner, President and CEO of Nuvilex stated "The receipt of shares by Nuvilex equating to a 14.5% equity interest in Austrianova not only completes the terms of the Asset Purchase Agreement between both companies, but also serves to cement further the excellent working relationships that have developed between our respective companies. We look forward to working closely with Professor Gunzburg, Dr. Salmons and their colleagues at Austrianova as we advance the use of the Cell-in-a-Box(TM) live-cell encapsulation technology in developing treatments for various cancers, for insulin-dependent diabetes and for disease treatments that involve components of marijuana and, in particular, as we prepare for our late-phase clinical trials in advanced pancreatic cancer."
http://finance.yahoo.com/news/nuvilex-nvlx-acquires-14-5-141500674.html?soc_src=mediacontentstory
$NVLX to Use Proprietary Cell-in-a-Box Technology to Develop Marijuana-Based Cancer Treatments 2/3/14 http://www.stockwatch.com/News/Item.aspx?bid=U-z10066623-U%3aNVLX-20140203&symbol=NVLX®ion=U
ReplyDelete$NVLX announced subsidiary, Medical Marijuana Sciences, Inc., plans to use the unique and proprietary cellulose-based live-cell encapsulation technology known as Cell-in-a-Box™ to develop treatments for serious and deadly forms of cancer. The revolutionary treatments will deliver cancer-fighting agents based on constituents of Cannabis(marijuana) that are known as cannabinoids.
ReplyDeleteIn developing cancer treatments utilizing the Cell-in-a-Box™ live-cell encapsulation technology, living cells that are capable of converting anti-cancer prodrugs into their cancer-killing forms are enclosed in protective cellulose-based, pin-head-sized capsules that are implanted in or near a cancer tumor. Following implantation of the Cell-in-a-Box™ capsules, the anticancer prodrugs are then administered. The combination of the Cell-in-a-Box™ technology with the anti-cancer prodrug ifosfamide has been shown in Phase 1/2 trials conducted in the early 2000s to be extremely effective in treating patients with advanced inoperable pancreatic cancer (see www.nuvilex.com/pancreatic-cancer). When the data from those trials were compared with historical data for Gemzar® (the only drug approved to date by the FDA as a single agent for the treatment of advanced pancreatic cancer), the median survival time was increased to 11 months (from 5.7 months for Gemzar®) using Nuvilex's treatment and the one-year survival rate with Nuvilex's treatment (36%) was double that seen with Gemzar®(18%). Tumor sizes were also reduced from 25-50% in 4 out of 14 patients and no serious treatment-related side-effects were experienced by any of the patients using the Cell-in-a-Box™ plus ifosfamide combination. This is because only one-third the dose of ifosfamide normally employed in treating other forms of cancer was used in the trials due to the unique nature of the Cell-in-a-Box delivery system.
In 2013, Nuvilex acquired exclusive worldwide and patented rights to use this cellulose-based encapsulation technology for the development of treatments for all forms of cancer. Medical Marijuana Sciences intends to take advantage of the opportunity to employ the Cell-in-a-Box™ encapsulation technology together with constituents of Cannabis for the development of treatments for some of the deadliest and most difficult-to-treat forms of cancer, such as gliomas (a type of brain cancer) and pancreatic cancer. The type of cells encapsulated using the Cell-in-a-Box™ live-cell encapsulation technology will be those that optimize the effectiveness and safety of naturally-occurring cannabinoids against such cancers in the same way that the technology was used in developing a unique treatment for pancreatic cancer.
Dr. Mark L. Rabe, Chairman of Medical Marijuana Sciences' Scientific Advisory Board commented, "Reputable scientific journals contain numerous reports that confirm the anti-cancer properties of cannabinoids. Initial trials have also documented the effectiveness of treating pancreatic cancer using the Cell-in-a-Box™ live-cell encapsulation technology. When taken along with the fact that Medical Marijuana Sciences' parent company, Nuvilex, owns the exclusive worldwide rights to utilize this technology in developing cancer treatments, we believe that Medical Marijuana Sciences is in a unique position to develop cannabinoid-based treatments for cancer that will set it far apart from others in the medical marijuana arena." http://www.stockwatch.com/News/Item.aspx?bid=U-z10066623-U%3aNVLX-20140203&symbol=NVLX®ion=U
$NVLX Medical Marijuana Could Bring Nuvilex and the National Football League Together 2/5/14 http://www.stockwatch.com/News/Item.aspx?bid=U-i1087448-U%3aNVLX-20140205&symbol=NVLX®ion=U
ReplyDelete$NVLX marijuana debate landed on the doorstep of the National Football League (NFL)
ReplyDeleteNEW YORK, NY -- (Marketwired) -- 02/05/14
Nuvilex, Inc. (OTCQB: NVLX) entered the medical marijuana arena in 2013 as a biotech that would use its expertise to develop treatments for hard to treat cancers. The company said it will initially utilize cannabidiol, one of the compounds found in Cannabis, as the basis for developing treatments for some of the deadliest forms of cancer, namely pancreatic cancer and cancers of the brain, that have historically shown they're extremely difficult to treat.
In the process of developing treatments for cancers of the brain, the company could find itself as the leader in researching the benefits of medicinal marijuana on concussions. With the Super Bowl just on the big stage, the marijuana debate landed on the doorstep of the National Football League (NFL). When asked, the league's commissioner, Roger Goodell said the NFL would consider allowing athletes to use marijuana to treat concussions and other head injuries if medical experts deemed it a legitimate solution.
Pete Carroll, the head coach of the Super Bowl Champion Seattle Seahawks, agrees with the commissioner. Carroll said he is in support of the NFL looking further into whether medicinal marijuana could be beneficial to players. In an ESPN SportsNation Poll answered by more than 66,000 people, 70 percent of those respondents said they too were okay with the NFL approving the use of medicinal marijuana.
When it comes to both cancer and diabetes, Nuvilex has exclusive worldwide rights to use Cell-in-a-Box™, a live-cell encapsulation technology that targets cancerous tumors, potentially inhibits progression, and treats the tumor at its core. So, while conducting research and developing treatments using Cannabis, Nuvilex and the NFL could find some common ground.
Nuvilex is one of the legitimate businesses in the marijuana industry waiting for regulations and nationwide legalization to play itself out in order to remove any legality that may face any company using the drug for medicinal purposes.
http://www.stockwatch.com/News/Item.aspx?bid=U-i1087448-U%3aNVLX-20140205&symbol=NVLX®ion=U
In 2013, Nuvilex acquired exclusive worldwide and patented rights to use this cellulose-based encapsulation technology for the development of treatments for all forms of cancer. Medical Marijuana Sciences intends to take advantage of the opportunity to employ the Cell-in-a-Box™ encapsulation technology together with constituents of Cannabis for the development of treatments for some of the deadliest and most difficult-to-treat forms of cancer, such as gliomas (a type of brain cancer) and pancreatic cancer. The type of cells encapsulated using the Cell-in-a-Box™ live-cell encapsulation technology will be those that optimize the effectiveness and safety of naturally-occurring cannabinoids against such cancers in the same way that the technology was used in developing a unique treatment for pancreatic cancer.
ReplyDelete$NVLX Cell-in-a-Box™ technology to develop marijuana-based treatments for cancer
ReplyDeleteNEW YORK, NY -- (Marketwired) -- 02/10/14If Nuvilex, Inc. (OTCQB: NVLX) can use the Cell-in-a-Box™ technology to develop marijuana-based treatments for cancer with the same success it has seen in two independent clinical trials to develop a treatment for advanced inoperable pancreatic cancer, then the Cannabis industry is in for some real fireworks.
Last week Nuvilex announced it will, in fact, use the unique and proprietary cellulose-based live-cell encapsulation technology, Cell-in-a-Box, to develop treatments for serious and deadly forms of cancer. In the announcement, the company stated the revolutionary treatments will deliver cancer-fighting agents based on constituents of Cannabis known as cannabinoids.
Since the company acquired the exclusive worldwide rights to use the technology to develop treatments for all types of cancer, Nuvilex's work with marijuana will include developing treatments for some of the deadliest and most difficult-to-treat forms of cancer, such as gliomas and pancreatic cancer. With late-phase clinical trials in advanced inoperable pancreatic cancer in Nuvilex's future, the company will likely learn a great deal from those trials which will use Cell-in-a-Box combined with the anti-cancer prodrug ifosfamide that it can then apply to its work with cannabinoids.
Nuvilex stated that the type of cells encapsulated using Cell-in-a-Box to develop marijuana-based treatments will be those that optimize the effectiveness and safety of naturally-occurring cannabinoids against deadly cancers in the same way the technology was used in developing a unique treatment for pancreatic cancer. Dr. Mark Rabe, is the Chairman of the Scientific Advisory Board for Nuvilex's Cannabis subsidiary, Medical Marijuana Sciences, and he believes that the company is in a unique position to develop cannabinoid-based treatments for cancer that will set it far apart from others in the medical marijuana arena.
For those following the Nuvilex story, you're well aware that Cell-in-a-Box has proven it can compete with the likes of Eli Lilly and Celgene in early pancreatic cancer results, so if its past is a prelude to its future, cancer patients could be in very good hands.
http://www.stockwatch.com/News/Item.aspx?bid=U-i1088468-U%3aNVLX-20140210&symbol=NVLX®ion=U
$NVLX Nuvilex is one of the legitimate businesses in the marijuana industry waiting for regulations and nationwide legalization to play itself out in order to remove any legality that may face any company using the drug for medicinal purposes.
ReplyDeletehttp://www.stockwatch.com/News/Item.aspx?bid=U-i1087448-U%3aNVLX-20140205&symbol=NVLX®ion=U
$NVLX News! Nuvilex's Dr. Mark Rabe Talks Medical Marijuana, Legalization and Cell-in-a-Box 2/12/14 http://www.stockwatch.com/News/Item.aspx?bid=U-i1089343-U%3aNVLX-20140212&symbol=NVLX®ion=U
ReplyDelete$NVLX Kenneth L. Waggoner, Chief Executive Officer and President:
ReplyDeleteKenneth L. Waggoner has almost four decades of experience in management, business, operations and law. Mr. Waggoner started his career as an attorney in private practice. Notably he was a senior partner with Brobeck, Phleger and Harrison, named one of the top two law firms worldwide that provide services to biotechnology clients including Chiron, Amgen, Biogen Idec, Sangamo, Ligand, DepoTech and many others. He was the Managing Partner of Brobeck’s Los Angeles office. Mr. Waggoner was also a member of the Executive Committee for almost ten years and on the Policy Committee for numerous years managing Brobeck’s worldwide operations with annual revenues in excess of $750,000,000. While at Brobeck, Mr. Waggoner was the Co-Chairman of Brobeck’s world-wide Environmental Law Group.
Further highlights of Mr. Waggoner’s career include leadership and legal positions with several start-up companies during the last several years as well as working with Fortune 500 companies most of his professional career. During his tenure with Chevron, Mr. Waggoner served as the Vice President and General Counsel of its Global Downstream operations where he was responsible for the overall management of legal services to the North American, Latin American, Europe and Asian Products Companies. At Chevron he led a successful restructuring of the company’s international Legal Department following Chevron’s acquisition of Texaco.
Mr. Waggoner received his Juris Doctorate. with honors in 1973 from Loyola University School of Law in Los Angeles.
http://www.nuvilex.com/management
$NVLX Congressional Legislators Agree with Nuvilex’s Dr. Mark Rabe on Reclassifying Marijuana 2/14/14 http://www.stockwatch.com/News/Item.aspx?bid=U-i1090099-U%3aNVLX-20140214&symbol=NVLX®ion=U
ReplyDelete$NVLX Dr. Mark L. Rabe has something in common with 18 members of Congress - All of them want marijuana reclassified
ReplyDeleteNEW YORK, NY -- (Marketwired) -- 02/14/14 Nuvilex, Inc.'s (OTCQB: NVLX) Dr. Mark L. Rabe has something in common with 18 members of Congress. All of them want marijuana reclassified from its current listing as a dangerous drug with no medical value, and they want President Obama to use his authority to make that change by removing marijuana from the Schedule I category. Currently marijuana is viewed in the same category as drugs like heroin and LSD, and in a letter sent to the president this week, 18 legislators said this status "makes no sense."
In the letter to President Obama, the 18 members of Congress said, "We request that you instruct Attorney General Holder to delist or classify marijuana in a more appropriate way, at the very least eliminating it from Schedule I or II."
Nuvilex appointed Dr. Rabe, a leading figure in the medical marijuana field, as the Chairman of the Scientific Advisory Board of Medical Marijuana Sciences, the company's wholly-owned subsidiary formed to house its work in the Cannabis industry.
Dr. Rabe agrees with the letter to the president. "The most important component of legalization is that the Cannabis plant and its medicinal cannabinoid components need to be removed from the federal "Schedule I" category. Because of this designation, doctors currently cannot legally treat patients with cannabinoids. Rather, they can only "recommend" the use of medical marijuana, which leaves patients on their own to obtain their own medicine and treat themselves."
The Congressional letter went on to state, "Classifying marijuana as Schedule I at the federal level perpetuates an unjust and irrational system. Schedule I recognizes no medical use, disregarding both medical evidence and the laws of nearly half of the states that have legalized medical marijuana."
Dr. Rabe realizes this is the first step to Nuvilex beginning its work with Cannabis and added, "Removal of the Schedule I designation would also allow for properly designed placebo-controlled double blind studies to occur in order to advance the use of cannabinoids as medicine."
http://www.stockwatch.com/News/Item.aspx?bid=U-i1090099-U%3aNVLX-20140214&symbol=NVLX®ion=U
$NVLX Pancreatic Cancer Treatment Readies to Challenge Eli Lilly and Celgene in Late-Phase Clinical Trials
ReplyDeleteNuvilex, Inc. (OTCQB: NVLX) is a small biotech firm in Silver Spring, Maryland, that hopes to soon be mentioned with much larger biotechnology and pharmaceutical companies like Eli Lilly and Celgene. If the company's pancreatic cancer treatment that combines the proprietary cellulose-based live-cell encapsulation technology known as Cell-in-a-Box™ with the anti-cancer drug ifosfamide can produce the same or better data in its upcoming late-phase clinical trials in advanced, inoperable pancreatic cancer than were seen with this same combination in two earlier independent Phase II trials, then not only will it be mentioned with those larger companies, Nuvilex's treatment will likely be the new "gold standard" for the disease.
So far, Nuvilex has methodically gone about its business laying the groundwork for its future trials. It's a process that demands a meticulous approach, especially when the outcome could lead to billions of dollars. Eli Lilly has realized more than $10 billion with its cancer drug Gemzar® (gemcitabine) since it was approved in 1996 as the gold standard for advanced, inoperable pancreatic cancer. It wasn't really until Celgene's drug Abraxane (a nanoparticle formulation of the widely used drug Taxol with albumin) in combination with gemcitabine was approved in 2013 that patients had a better option than single-agent gemcitabine.
Approval of Celgene's treatment was undoubtedly assisted by the involvement of Dr. Daniel D. Von Hoff, who was also the principal investigator for the first clinical trial of gemcitabine and is considered among the nation's leading authorities on pancreatic cancer. In his role as Consultant to Celgene, Dr. Von Hoff helped to get approval for Celgene's Abraxane-gemcitabine combination fast-tracked by showing the FDA that there is an urgent need for better treatments for advanced pancreatic cancer.
Now it is Nuvilex's turn. The company's advanced pancreatic cancer treatment that combines the Cell-in-a-Box technology with ifosfamide has provided better results than both gemcitabine alone and the Abraxane-gemcitabine combination. Those results included an increase of about 4 months in median survival time over gemcitabine alone versus the 1.8 months seen with the Abraxane-gemcitabine combination. The results also included a 100% increase in the one-year survival rate as compared to gemcitabine versus a 59% increase for the Abraxane-gemcitabine combination. The results obtained with Nuvilex's treatment are even more noteworthy given that only one-third of the dose of ifosfamide normally used to treat other types of cancer was used in the Phase II pancreatic cancer trials.
Another apparent advantage for Nuvilex's treatment compared to the Abraxane-gemcitabine combination concerns the side effects (toxicities) associated with both treatments. Significant and severe drug-associated toxicities were seen with the Abraxane-gemcitabine combination, whereas with Nuvilex's treatment, side effects were essentially non-existent. The lack of side effects from the Cell-in-a-Box-ifosfamide combination is undoubtedly related to the low dose of ifosfamide used.
For Nuvilex's investors, the good news is that, once funding is secured for the late- phase clinical trials, companies like Celgene are likely to take notice. After all, the global biopharmaceutical was able to quickly get the Abraxane-gemcitabine combination approved by showing both an urgent need for better pancreatic cancer treatments and better results than those seen 17 years before with the prior gold standard Gemzar. Well, nothing has changed - there is still a need, and Nuvilex may just prove again its treatment consisting of the combination of Cell-in-a-Box with ifosfamide can produce even better results than Celgene's recently approved therapy.
http://www.stockwatch.com/News/Item.aspx?bid=U-i1091081-U%3aNVLX-20140219&symbol=NVLX®ion=U
$NVLX Nuvilex Announces $27 Million Funding Commitment With Institutional Investor to Advance Late Phase Clinical Trials
ReplyDeleteSILVER SPRING, Md., Feb. 20, 2014 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (OTCQB:NVLX), an international biotechnology company providing cell and gene therapy solutions for the treatment of deadly diseases, announced today that it has entered into a stock purchase agreement with Lincoln Park Capital Fund, LLC (Lincoln Park), a Chicago-based institutional investor. Lincoln Park initially purchased 8 million shares of Nuvilex's common stock at $0.25 per share for $2 million and has committed to invest, at the sole option of Nuvilex, up to an additional $25 million of equity capital over the term of the purchase agreement. The proceeds from this investment will be used for Nuvilex's late-stage clinical trials in advanced inoperable pancreatic cancer, for research into the use of constituents of marijuana in the emerging medical marijuana arena and for general operating purposes.
Kenneth L. Waggoner, the CEO and President of Nuvilex, commented, "Our stock purchase agreement with Lincoln Park gives Nuvilex the flexibility to access capital over time at prevailing market prices and as our needs arise. The initial funding helps us to proceed with our planned late-stage pancreatic cancer clinical trials. The $2 million initial investment also reflects the commitment to Nuvilex and our live-cell encapsulation platform for developing treatments for cancer and diabetes."
During the 36-month term of the stock purchase agreement, Nuvilex, at its sole discretion, has the right to sell Lincoln Park up to an additional $25 million of Nuvilex common stock in amounts as described in the agreement and subject to certain conditions which include the effectiveness of a registration statement with the U.S. Securities and Exchange Commission (SEC) covering the sale of the shares that may be issued to Lincoln Park. Nuvilex controls the timing and amount of any future investment. Lincoln Park is obligated to make purchases if and when Nuvilex decides.
Under the terms of the stock purchase agreement, there are no upper limits on the price Lincoln Park may pay to purchase Nuvilex's common stock. The purchase price of the shares related to any future investments will be based on the prevailing market prices of Nuvilex's shares immediately preceding a notice of sale to Lincoln Park. Lincoln Park has agreed not to cause or engage in any direct or indirect short selling or hedging of Nuvilex's common stock. The stock purchase agreement may be terminated by Nuvilex at any time at its sole discretion and without any monetary cost to Nuvilex.
A more detailed description of the stock purchase agreement is set forth in the Nuvilex's Current Report on Form 8-K already filed with the SEC and which Nuvilex encourages be reviewed carefully.
This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in any offering, nor will there be any sale of securities of Nuvilex in any jurisdiction in which such offer solicitation or sale are unlawful prior to registration or qualification under securities laws of any such jurisdiction.
http://www.stockwatch.com/News/Item.aspx?bid=U-z10069225-U%3aNVLX-20140220&symbol=NVLX®ion=U
$NVLX - Move Over Celgene Here Comes Nuvilex and $27 Million to Advance Its Pancreatic Cancer Clinical Trials 2/21/14 http://www.stockwatch.com/News/Item.aspx?bid=U-i1091945-U%3aNVLX-20140221&symbol=NVLX®ion=U
ReplyDelete$NVLX - Chicago Investment Firm Assumes $27 Million Risk to Help Nuvilex Unseat Celgene and Eli Lilly
ReplyDeleteNEW YORK, NY -- (Marketwired) -- 02/24/14 Lincoln Park Capital (LPC) purchased 8 million restricted shares of Nuvilex, Inc. (OTCQB: NVLX) in exchange for an initial $2 million out of what can be viewed as a $27 million "pot of money" to advance the company's late-phase pancreatic cancer clinical trials. Notice we said restricted shares, that's right, LPC has put a great deal of its money on the line with a number of built in protections for Nuvilex. But, is this investment really a risk? It appears the Chicago-based firm knows exactly what the future could hold for Nuvilex, and they're comfortable with paying a premium price to become a long-term investor right along with many others who believe in the small biotechnology firm.
Much like its investment with Elite Pharmaceuticals in April 2013 that has since seen that company's price per share rise to highs of over 500%, LPC could benefit greatly from a much higher price tag when Nuvilex enters late-phase clinical trials, completes those trials and applies for approval with the FDA.
LPC has at least two members of its team, Dr. Michael Beaubaire and Jonathan Cope, who are biotech savvy and have clearly seen the results from two previous independent Phase II clinical trials using the pancreatic cancer treatment that combines Cell-in-a-Box™ live-cell encapsulation with the anti-cancer drug ifosfamide - a treatment recently licensed by Nuvilex. Those results indicated that this combination treatment outperformed Eli Lilly's long-time single-agent treatment for advanced inoperable pancreatic cancer, Gemzar® (gemcitabine), and Celgene's recently approved drug Abraxane (a nanoparticle formulation of the widely used drug Taxol with albumin) in combination with gemcitabine.
Results from the Cell-in-a-Box-ifosfamide combination in patients with advanced pancreatic cancer included almost a doubling of median survival time from 5.7 months for Gemzar to the 11 months seen with the combination; this compares to the 8.5 months seen with the Abraxane-gemcitabine combination. The results also included a 100% increase in the one-year survival rate as compared to gemcitabine versus a 59% increase for the Abraxane-gemcitabine combination.
The results obtained with the Cell-in-a-Box-ifosfamide combination are even more noteworthy given that only one-third of the dose of ifosfamide normally used to treat other types of cancer was used in the Phase II pancreatic cancer trials. It is likely that this lower dosage also contributed to the fact that there were no significant side effects from the Cell-in-a-Box-ifosfamide combination. However, there were significant and severe drug-associated toxicities seen with both single-agent Gemzar and with the Abraxane-gemcitabine combination.
LPC realizes that if these results can be repeated in Nuvilex's planned late-phase clinical trials, then the FDA approved treatments developed by biopharmaceutical giants Celgene and Eli Lilly will surely be unseated as the "gold standard" treatment for advanced inoperable pancreatic cancer. Keep in mind Eli Lilly has parlayed gemcitabine into more than $10 billion.
Nuvilex owns the exclusive worldwide rights to use the Cell-in-a-Box technology to develop treatments for any type of cancer and for treatments for diabetes as well. The technology has already shown equally amazing results in animal studies in both breast cancer and diabetes. So, it doesn't stop at pancreatic cancer for Nuvilex or any investor with a position in the company's stock, and that includes Lincoln Park Capital.
http://www.stockwatch.com/News/Item.aspx?bid=U-i1092297-U%3aNVLX-20140224&symbol=NVLX®ion=U
Notice $NVLX said restricted shares, that's right, LPC has put a great deal of its money on the line with a number of built in protections for Nuvilex http://www.stockwatch.com/News/Item.aspx?bid=U-i1092297-U%3aNVLX-20140224&symbol=NVLX®ion=U
ReplyDelete$NVLX - Comprehensive Analyst Report Answers Vital Questions for Shareholders, by BrokerBank Securities, Inc.
ReplyDeleteNEW YORK, Feb. 26, 2014 /PRNewswire/ -- Nuvilex, Inc. (OTCQB: NVLX) owns exclusive rights to a cancer treatment platform that has successfully completed Phase 2 clinical trials for inoperable pancreatic cancer. Nuvilex also owns rights to the same platform to treat diabetes, and the company also has a medical marijuana subsidiary slated to begin cancer research and development using cannabidiol. With each of the key target markets representing multi-billion-dollar opportunities, Nuvilex offers investors multiple opportunities for success and should trade at a valuation that reflects its current development progress to date.
The company primarily focuses on the advancement of its treatment for advanced, inoperable pancreatic cancer that combines the Cell-in-a-Box technology with the anti-cancer drug ifosfamide. This treatment has completed Phase 1/2 clinical trials. The company, through its subsidiary, Medical Marijuana Sciences, Inc., uses constituents of Cannabis in developing treatments for cancer, particularly those that are difficult to treat
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With the excitement and buzz circulating around this stock in the last few months there is a lot of speculation as to the validity of NVLX. To help investors get a better grasp on NVLX, we have decided to offer a comprehensive research report below.
This comprehensive research report is authored by a Chartered Financial Analyst and includes vital information that every shareholder of NVLX must read. There is no charge for this report. Included in the report you will find recent highlights of NVLX, Overview of the Global Pharmaceuticals Industry, U.S Food and Drug Administration's (FDA) Approval process for NVLX products, in-depth description of company history, pipeline drugs and current stage, financial position, valuation of company, analyst summary, and price target: http://bit.ly/NVLX-PriceTarget copy and paste may be required
http://www.stockwatch.com/News/Item.aspx?bid=U-prDE72008-U%3aNVLX-20140226&symbol=NVLX®ion=U
$NVLX - owns rights to the same platform to treat diabetes, and the company also has a medical marijuana subsidiary slated to begin cancer research and development using cannabidiol http://www.stockwatch.com/News/Item.aspx?bid=U-prDE72008-U%3aNVLX-20140226&symbol=NVLX®ion=U
ReplyDelete$NVLX closed @ .51 yesterday & a Chicago-based firm knows exactly what the future could hold for Nuvilex, and they're comfortable with paying a premium price to become a long-term investor
ReplyDeletehttp://www.stockwatch.com/News/Item.aspx?bid=U-i1092297-U%3aNVLX-20140224&symbol=NVLX®ion=U
$NVLX - Nuvilex Funding Has Investors Preparing for Milestone Announcements in Late-Phase Clinical Trials
ReplyDeleteNEW YORK, NY -- (Marketwired) -- 03/03/14 Nuvilex (OTCQB: NVLX) investors who have patiently waited for the R&D biotech to reach a point where late-phase clinical trials were a reality, are probably relishing these truly exciting times after a Chicago-based institutional investor committed to fund $27 million dollars toward the company's clinical trials in advanced inoperable pancreatic cancer. Leading up to the aforementioned clinical trials, investors can expect to see a list of milestone developments unfold, and for those who consider themselves biotech junkies, they know this is when the fun begins.
It is likely just a matter of time now before investors start hearing words like Good Manufacturing Practices (GMP), Principal Investigator (PI), Protocol, Contract Research Organization (CRO), Study Sites, etc., and with each of these milestone developments, Nuvilex draws closer to the actual patient recruitment process and eventual patient enrollment for the clinical trials.
Additional news events to pay attention to will be the cloning of the cancer-drug-activating cells that are required for the clinical trials. The cloning began last November at Inno Biologics, and this process is necessary to obtain the large numbers of cells required for the late-phase trials. Also, locating facilities in which the encapsulation of these large numbers of cells can be done according to GMP standards is also crucial, and the company says GMP compliance is an absolute requirement for drug regulatory authorities. With funding now flowing into the company, expect to see activity start to pick up.
For those unfamiliar with where Nuvilex is heading, here's a quick recap. Nuvilex acquired the exclusive worldwide rights to use the Cell-in-a-Box™ live-cell encapsulation technology to develop treatments for diabetes and any form of cancer. Now the company is preparing to advance late-phase clinical trials using the licensed pancreatic cancer treatment that combines Cell-in-a-Box with the anti-cancer drug ifosfamide to build upon two previous independent Phase II clinical trials.
The excitement for the company and its investors is that, in those two completed Phase II trials, the treatment that Nuvilex owns the rights to use outperformed Eli Lilly's long-time single-agent treatment for advanced inoperable pancreatic cancer, Gemzar® (gemcitabine), and Celgene's recently approved drug Abraxane (a nanoparticle formulation of the widely used drug Taxol with albumin) in combination with gemcitabine.
If Nuvilex's late-phase clinical trials can continue to outperform Celgene's therapy, then the company's treatment will likely be the new "gold standard" for the disease -- a designation that earned Eli Lilly's drug Gemzar more than $10 billion when it was the "gold standard" for advanced inoperable pancreatic cancer. It is numbers like this that make it clear why so many have remained patient with their Nuvilex investment, and we haven't even begun to discuss the company's future in diabetes!
http://www.stockwatch.com/News/Item.aspx?bid=U-i1094446-U%3aNVLX-20140303&symbol=NVLX®ion=U
The excitement for $NVLX - and its investors is that, in those two completed Phase II trials, the treatment that Nuvilex owns the rights to use outperformed Eli Lilly's long-time single-agent treatment for advanced inoperable pancreatic cancer, Gemzar® (gemcitabine), and Celgene's recently approved drug Abraxane (a nanoparticle formulation of the widely used drug Taxol with albumin) in combination with gemcitabine http://www.stockwatch.com/News/Item.aspx?bid=U-i1094446-U%3aNVLX-20140303&symbol=NVLX®ion=U
ReplyDeleteIf $NVLX - Nuvilex's late-phase clinical trials can continue to outperform Celgene's therapy, then the company's treatment will likely be the new "gold standard" for the disease -- a designation that earned Eli Lilly's drug Gemzar more than $10 billion when it was the "gold standard" for advanced inoperable pancreatic cancer. It is numbers like this that make it clear why so many have remained patient with their Nuvilex investment, and we haven't even begun to discuss the company's future in diabetes! http://www.stockwatch.com/News/Item.aspx?bid=U-i1094446-U%3aNVLX-20140303&symbol=NVLX®ion=U
ReplyDelete$NVLX Recent Events Effectively De-Risk Nuvilex, Inc.
ReplyDeleteBALTIMORE, Maryland, March 6, 2014 /PRNewswire/ --Goldman Small Cap Research, a stock market research firm focused on the small cap and micro cap sectors, recently published a new research update on Nuvilex Inc. (OTCQB: NVLX). In the update, senior analyst Rob Goldman outlines his latest thesis.
"In our view, with institutional funding in place to a potential $27 million, Nuvilex has been transformed from an also-ran to a soon-to-be-prime time player in the biotech and medical marijuana arenas. Moreover, this funding agreement validates the Company's technology and effectively de-risks the stock."
Nuvilex is a biotechnology company with the rights to a novel cellulose-based live-cell encapsulation technology, called Cell-in-a-Box™, that will be used as a platform upon which treatments for several types of cancer, including advanced, inoperable pancreatic cancer, and diabetes are being built. Nuvilex's treatment for pancreatic cancer involves the use of the widely used anticancer prodrug, ifosfamide, together with encapsulated live cells that convert ifosfamide into its active or "cancer-killing" form. Nuvilex's subsidiary, Medical Marijuana Sciences, Inc., is dedicated to the development of cancer treatments based upon the well-known chemical constituents of marijuana. Nuvilex is exploring ways in which the Cell-in-a-Box™ technology may play a role in these efforts.
According to Goldman, now that an institution has validated the company, attention will be focused on fundamentals and a series of future milestones and executable events, which means a higher future valuation for the company and all three of its treatment categories: cancer, diabetes, and medicinal marijuana. Moreover, since all three categories address high profile, multi-billion dollar markets, the associated future valuation adjustments could be substantial as milestone events are executed. http://www.stockwatch.com/News/Item.aspx?bid=U-prenUK201403052285A-U%3aNVLX-20140306&symbol=NVLX®ion=U
$NVLX - Nuvilex Partner Austrianova Establishes Regional Headquarters and Research and Development Facility at Thailand Science Park for Cell-in-a-Box(TM) Live-Cell Encapsulation
ReplyDeleteRead More:
http://www.stockwatch.com/News/Item.aspx?bid=U-z10071577-U%3aNVLX-20140306&symbol=NVLX®ion=U
$NVLX - Nuvilex Appoints Dr. Garret L. Yount to Its Subsidiary's Scientific Advisory Board
ReplyDeleteRead More:
http://www.stockwatch.com/News/Item.aspx?bid=U-z10071704-U%3aNVLX-20140307&symbol=NVLX®ion=U
$NVLX - Nuvilex appointed Dr. Rabe, a leading figure in the medical marijuana field quoted in article about a minister's daughter stating - Cannabis 'a gift from God'
ReplyDelete"Patients often come into my office and drop down a brown bag full of pill bottles on my desk and say, 'I'm off Oxycodone; I'm off muscle relaxants. I'm off Ambien; I'm off Trazodone,' because medical cannabis does the job better," said Rabe, who runs Centric Wellness in San Diego http://www.cnn.com/2014/03/07/health/cannabis-pain/
$NVLX Nuvilex Appoints CEO and President of Austrianova to Scientific Advisory Board
ReplyDeleteNuvilex Appoints CEO and President of Austrianova to Scientific Advisory Board Dr. Brian Salmons Indispensable for Development of Cannabis-Based Cancer Treatments SILVER SPRING, Md., March 11, 2014 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (OTCQB:NVLX), an international biotechnology company providing cell and gene therapy solutions for the treatment of deadly diseases, announced today that its subsidiary, Medical Marijuana Sciences, Inc., has appointed Brian Salmons, Ph.D., CEO and President of Nuvilex's partner Austrianova, to its Scientific Advisory Board. Dr. Salmons, together with Professor Dr. Walter H. Günzburg, invented and developed the live-cell encapsulation technology now known as Cell-in-a-Box(TM) which has been licensed by Nuvilex for the development of treatments for cancer and diabetes. It is expected that, given his expertise in this and other aspects of the development of disease treatments, Dr. Salmons will play a pivotal role as Medical Marijuana Sciences goes forward with its cannabis-based cancer treatments. Dr. Brian Salmons received his Ph.D. in London. After research positions in the U.S.A., Switzerland and at the Ludwig Maximilian University in Munich, Germany, Dr. Salmons became the Scientific Director of the European biotech/vaccine company, Bavarian Nordic, and was intricately involved in taking the company to an IPO. Bavarian Nordic was sponsor of the Phase1/2 clinical trial in patients with advanced, inoperable pancreatic cancer that involved the use of the combination of live-cell encapsulation and the anti-cancer prodrug ifosfamide. The results of this trial showed that the combination was safe and efficacious. These results were reported in reputable scientific literature and can be viewed by clicking here (please scroll down and click on blue title opposite "121-131"). In 2002, Dr. Salmons co-founded the biotech company, Austrianova, originally a "spin-off" from the Veterinary Medicine University in Vienna. He was instrumental in obtaining orphan drug status from the European Medicines Agency for its lead cell encapsulation product. In 2007, Dr. Salmons co-founded and became the CEO and President of Austrianova Singapore Pte. Ltd., an independent company established in Singapore to further develop the live-cell encapsulation technology as products for a variety of indications such as various forms of cancer, diabetes, neurodegenerative, cardiovascular and infectious diseases. Dr. Salmons is the author or co-author of over 120 peer-reviewed scientific articles and inventor of 8 patent families. Dr. Mark L. Rabe, Chairman of Medical Marijuana Sciences' Scientific Advisory Board, commented, "Dr. Salmons' acceptance of his appointment as a member of the Medical Marijuana Sciences Scientific Advisory Board is a major coup for Nuvilex. His complete knowledge of the Cell-in-a-Box(TM) encapsulation technology, and its many possible applications, will be invaluable as we strive to develop treatments for the deadliest of all cancers employing Cell-in-a-Box(TM) technology in combination with cannabis-based compounds."
http://www.stockwatch.com/News/Item.aspx?bid=U-z10072083-U%3aNVLX-20140311&symbol=NVLX®ion=U
$NVLX is on n the road to late-phase clinical trials for pancreatic cancer treatment!!! http://www.stockwatch.com/News/Item.aspx?bid=U-z10071577-U%3aNVLX-20140306&symbol=NVLX®ion=U
ReplyDeleteFor those unfamiliar with where $NVLX and where Nuvilex is heading, here's a quick recap http://www.stockwatch.com/News/Item.aspx?bid=U-i1094446-U%3aNVLX-20140303&symbol=NVLX®ion=U
ReplyDelete$NVLX - News events to pay attention to will be the cloning of the cancer-drug-activating cells that are required for the clinical trials http://www.stockwatch.com/News/Item.aspx?bid=U-i1094446-U%3aNVLX-20140303&symbol=NVLX®ion=U
ReplyDelete$NVLX New 10Q March 17, 2014 updated SS Common Stock, authorized 1,490,000,000 shares, $0.0001 par value, 602,958,014 and 482,106,348 shares issued and outstanding, respectively
ReplyDeletehttp://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=9858980
$NVLX News! - Professor Dr. Walter H. Gunzburg, Executive Chairman and Chief Technical Officer of Nuvilex Affiliate SG Austria, Presents at 2014 BioPharma Asia Convention in Singapore 3/17/14 http://www.stockwatch.com/News/Item.aspx?bid=U-z10072790-U%3aNVLX-20140317&symbol=NVLX®ion=U
ReplyDelete$NVLX presentation entitled "Cell-in-a-Box® Living Cell Encapsulation Products for Medical and Healthcare Use" given during the Clinical Trials section of the Convention's program, Dr. Günzburg reviewed the data from the early/mid-phase clinical trials that were done with the combination of Cell-in-a-Box® and the anti-cancer prodrug ifosfamide in patients with advanced inoperable pancreatic cancer; In those Phase 1 and Phase 2 clinical trials, the Cell-in-a-Box®/ifosfamide combination treatment was shown to essentially double the median survival time and percentage of one-year survivors over those seen in historical data for Gemzar® (gemcitabine), the only drug approved to date by the FDA as a single agent for the treatment of the disease. But unlike Gemzar®, Nuvilex's treatment had no serious treatment-related side effects associated with it because the dose of ifosfamide used in these trials was only one-third of that normally employed for cancer treatment. http://www.stockwatch.com/News/Item.aspx?bid=U-z10072790-U%3aNVLX-20140317&symbol=NVLX®ion=U
ReplyDelete$NVLX gave a major presentation at the international BioPharma Asia Convention 2014 that was held in Singapore March, 10-13, 2014 http://www.stockwatch.com/News/Item.aspx?bid=U-z10072790-U%3aNVLX-20140317&symbol=NVLX®ion=U
ReplyDelete$NVLX Contracts With Austrianova for cGMP-Compliant Cell-in-a-Box(R) Encapsulation of Cells for Clinical Trials
ReplyDeleteNEW YORK, NY -- (Marketwired) -- 03/20/14 LiveDeal, Inc. (NASDAQ: LIVE) has generated a lot of attention since entering the online deal space and that attention has been well deserved. The company's instant, real-time concept makes more sense for users than the model used by long-time industry leaders like Groupon and others. Quite simply when business owners need more customers, they will create a promotion with an online deal site to help introduce their brand to potential consumers. LiveDeal launched its online deal platform in the restaurant industry, and with it, it's giving those restaurants the opportunity to reach customers immediately and in real-time.
The introduction of this instant, real-time model gives www.livedeal.com plenty of potential as an on-going technology platform into the future. LiveDeal recently announced that it is ramping up its deal procurement team so that it can quickly grab market share. It is clear that the first step the company is taking is to build an audience. In technology, the name of the game is potential. Instagram, for instance, had 30 million users when it was acquired, but to arrive at a fair value for acquisition, the technology's future potential had to be included in the evaluation. Instagram has proven that potential with close to 150 million users.
In technology, since most platforms are so scalable, those looking to acquire these technologies project 2, 3 and 5-years out in time to see where the product could be, and usually pay a multiple based on future potential, not actual results at the time. This bodes well for LiveDeal and its online and mobile deal engine, livedeal.com.
LiveDeal seems to understand that the name of the game is potential and that building a technology's popularity by increasing its number of users could equate to more and more dollars in the company's future. With each major city that the company has added to its platform, there is the market to add thousands of new restaurants to create promotions and potentially millions of new consumers to view and use those real-time deals.
Because LiveDeal's platform gives the restaurant owner all of the control, creates a direct relationship between merchant and consumer and eliminates the middleman by letting consumers pay for the promotions found on livedeal.com directly to the restaurant, the platform has to be taken seriously in the industry.
Other online deal sites in the industry don't offer all of these advantages, so using a media campaign to drive more and more users to the company's platform should only serve to make this model the way merchants advertise promotions and consumers find their deals well into the future.
http://www.stockwatch.com/News/Item.aspx?bid=U-z10073394-U%3aNVLX-20140320&symbol=NVLX®ion=U
$NVLX - Nuvilex Selects Translational Drug Development (TD2) to Advance Treatment for Pancreatic Cancer 4/1/14 http://www.stockwatch.com/News/Item.aspx?bid=U-z10074859-U%3aNVLX-20140401&symbol=NVLX®ion=U
ReplyDelete$NVLX - Daniel D. Von Hoff, M.D., Chief Development Officer of TD2 will play a key role
ReplyDeletein the Pancreatic Cancer Research Team (PCRT) colleagues are enthusiastic to begin clinical trials
Dr Hoff had a hand in $CELG and $LLY
http://www.stockwatch.com/News/Item.aspx?bid=U-z10074859-U%3aNVLX-20140401&symbol=NVLX®ion=U
$NVLX Investors Should Read Between the Lines as Company Attracts World Renowned Oncologist 4/3/14 http://www.stockwatch.com/News/Item.aspx?bid=U-i1103787-U%3aNVLX-20140403&symbol=NVLX®ion=U
ReplyDelete$NVLX - Dr. Von Hoff will play a pivotal role in the development of our treatment for patients with advanced pancreatic cancer. http://www.stockwatch.com/News/Item.aspx?bid=U-z10074859-U%3aNVLX-20140401&symbol=NVLX®ion=U $CELG $LLY
ReplyDelete$NVLX - Medical Marijuana Sciences' Dr. Mark L. Rabe Speaks at ASA Medical Cannabis Unity Conference in Washington DC
ReplyDeleteSILVER SPRING, Md., April 8, 2014 (GLOBE NEWSWIRE) -- Medical Marijuana Sciences, Inc., a subsidiary of Nuvilex, Inc. (OTCQB:NVLX), a clinical-stage international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, reported today that Dr. Mark L. Rabe's presentation at the National Medical Cannabis Unity Conference, held this past weekend in Washington DC, prompted numerous questions and a lively discussion on Nuvilex's proprietary Cell-in-a-Box® platform and how Medical Marijuana Sciences is working to combine it with the cancer-fighting properties of cannabinoids.
The conference, hosted by Americans for Safe Access (ASA) and titled, "Navigating Medicinal Cannabis in the Mainstream," was attended by several hundred medical marijuana patients, parents of pediatric patients, educators, veterans, physicians, and other individuals calling for a stronger commitment to the safe, medicinal use of cannabis.
"It was a profound and humbling experience to see the dedication, commitment and sacrifice put forth by the members and sponsors of the ASA. This group of individuals has fought tirelessly to provide patients with safe access to cannabis-based medicine," said Dr. Rabe. "It was also encouraging to hear recently from the federal government comments about the potential of reclassifying or declassifying cannabis from its present status, which would provide the opportunity to advance scientific research and further the development of potentially life-saving cannabinoid-based therapies."
Dr. Rabe's presentation, "Targeted Cannabinoid-based Chemotherapy Utilizing Cell-in-a-Box® Technology," addressed new research that Medical Marijuana Sciences is undertaking in the fight against pancreatic and brain cancers and highlighted how further research is needed to help prevent the tens of thousands of deaths that occur each year as a result of these two diseases.
"Dr. Rabe is Chairman of Medical Marijuana Sciences' Scientific Advisory Board and is a well-respected veteran in the discussion of medical marijuana. His insight on the potential use of cannabinoids, particularly in combination with our parent company's Cell-in-a-Box® technology to treat these difficult cancers, has proven vital to our evolution as a company," said Tim Matula, President of Medical Marijuana Sciences. "Recent surveys have demonstrated that oncologists, among other top medical practitioners, have a keen interest in the potential use of cannabinoids both in compassionate care and in the fight against cancer and other deadly diseases; many have spoken and continue to speak openly about its decriminalization and the possible research applications that could result."
About Medical Marijuana Sciences:
Medical Marijuana Sciences, Inc. is the newest wholly-owned subsidiary of Nuvilex, Inc. It was established in early 2013 with the initial mission to develop treatments based on constituents of cannabis for two of the most serious and deadly forms of cancer, namely brain and pancreatic cancers.
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$NVLX Dr. Rabe's presentation, "Targeted Cannabinoid-based Chemotherapy Utilizing Cell-in-a-Box® Technology," addressed new research that Medical Marijuana Sciences is undertaking in the fight against pancreatic and brain cancers and highlighted how further research is needed to help prevent the tens of thousands of deaths that occur each year as a result of these two diseases http://www.stockwatch.com/News/Item.aspx?bid=U-i1104909-U%3aLIVE-20140408&symbol=LIVE®ion=U
ReplyDelete$NVLX - Nuvilex Engages ViruSure to Establish Cell Banks for Phase 2b Clinical Trials in Pancreatic Cancer
ReplyDeleteSILVER SPRING, Md., April 10, 2014 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (OTCQB:NVLX), a clinical-stage international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, reported today that it has signed a Master Services Agreement with ViruSure GmbH, located in Vienna, Austria, to develop and maintain Master, Working and End of Production Cell Banks. These cell banks are necessary steps in the production of the cells to be encapsulated using the Cell-in-a-Box® technology for Nuvilex's Phase 2b clinical trials in advanced, inoperable pancreatic cancer to be conducted in Australia.
"ViruSure has previous experience in handling the exact cell line that will be used in our Phase 2b clinical trials, which was a major factor in Nuvilex selecting ViruSure for this important step in our preparations for these trials," said Kenneth L. Waggoner, CEO and President of Nuvilex. "This decision was further supported by our on-site inspection of the ViruSure facilities and the excellent historical relationships between ViruSure's key personnel with our partners at Austrianova. ViruSure has years of experience in producing and maintaining cell banks and is an industry leader in this arena."
"We are delighted to be partnering with Nuvilex on such an important project and in helping to bring this much needed therapy for such a devastating disease as pancreatic cancer to the clinic," stated Andy Bailey, CEO and co-founder of ViruSure.
The cells that will make up the Master, Working and End of Production Cell Banks will be those that convert the anticancer drug ifosfamide into its cancer-killing form. These therapeutic cells will be shipped to ViruSure for propagation. First a Master Cell Bank will be established where aliquots of cells will be stored frozen. Cells from the Master Cell Bank will be propagated to make up the large number of cells that will comprise the Working Cell Bank. Ultimately, cells from the Working Cell Bank will be encapsulated using the Cell-in-a-Box® live cell encapsulation technology. An End of Production Cell Bank will then be made from the final product for quality control purposes. The encapsulated cell product, together with ifosfamide, forms Nuvilex's treatment for pancreatic cancer.
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$NVLX - new agreement for cell banks are necessary steps in the production of the cells to be encapsulated using the Cell-in-a-Box® technology for Nuvilex's Phase 2b clinical trials in advanced, inoperable pancreatic cancer to be conducted in Australia http://www.stockwatch.com/News/Item.aspx?bid=U-z10076266-U%3aNVLX-20140410&symbol=NVLX®ion=U
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