SILVER SPRING, Md., Dec 18, 2012 (GLOBE NEWSWIRE via COMTEX) --
Nuvilex, Inc. (OTCQB:NVLX), an international biotechnology provider of cell and gene therapy solutions, announced today that major aspects of its core, "platform," cell encapsulation technology were discussed recently by Nuvilex's COO, Dr. Gerald W. Crabtree, during an interview with SmallSector.com. Advantages of Nuvilex's cell encapsulation technology, as well as its possible applications in the development of treatments for serious, debilitating, and even fatal diseases were emphasized.
In discussing Nuvilex's unique, proprietary cell encapsulation technology, Dr. Crabtree noted our capsules (composed largely of cellulose) are "inert" in the body, are "tiny" and can contain large numbers of cells. In order for the cells to remain healthy, the capsules have "pores" through which nutrients for the encapsulated cells enter and waste products and "beneficial" factors produced by the cells are able to exit.
Advantages of our cell encapsulation technology mentioned include: (a) it is a "platform" upon which treatments for many diseases may be built - virtually any type of cells (e.g. drug-activating cells, drug-producing cells, stem cells, probiotic bacteria) can be encapsulated with only very minor modifications of our process; (b) it is "mature" and has been developed and validated using Good Manufacturing Practices (GMP) standards, a requirement for approval by drug regulatory agencies such as the FDA; (c) our capsules are composed largely of cellulose, thus, they are inert - they do not elicit any damage to normal body tissues near the capsules, and the size of the pores in the capsules does not permit the encapsulated cells to leave the capsules, nor does it allow cells of the body's immune system to enter the capsules to attack, and reject, the cells themselves; (d) encapsulated cells can be frozen and stored for long periods without undue damage [necessary for shipment of cells to distant locations].
Pancreatic cancer is the fourth deadliest form of cancer worldwide. According to the American Cancer Society, about 42,000 people in the US alone are expected to be diagnosed, with about 38,000 deaths expected in 2012. Only Gemzar(R) has been approved by the FDA as a single agent for the treatment of advanced, non-surgically-removable (non-resectable), pancreatic cancer; it is the "gold standard" in this regard. We have conducted two "mid-phase" clinical trials in patients with this cancer where "our treatment" (combination of the cancer drug, ifosfamide, with encapsulated cells capable of converting ifosfamide to its "cancer-killing" form) was used. Results from these trials included: (a) median survival time and one-year survival rate were almost doubled as compared to historical data for Gemzar(R); (b) severity of ifosfamide's side effects were reduced because 1/3 of its usual dose was used; (c) no damage to tissues surrounding capsules was seen; (d) cells within the capsules were protected from attack by the patients' immune systems; (e) cells inside the capsules were alive and functioning - even after more than two years. Preparations have begun for a large-scale trial where 50% of patients with advanced pancreatic cancer will be treated with "our treatment" and 50% will receive Gemzar(R). The studies are planned for multiple sites in multiple countries. If results from our previous studies are confirmed, this treatment could replace Gemzar(R) as the "gold standard" for the therapy of this devastating disease.
Diabetes has been diagnosed in 371 million people worldwide and 187 million others may have undiagnosed disease. The market for diabetes medicines has been projected to approach $65 billion by 2020. In the interview, the results of a study in which pancreatic islet cells (responsible for producing insulin) from pigs were implanted into diabetic rats, were summarized. Within days, the rats' blood glucose levels were normal, and remained so for the duration (6 months) of the study. At the end of the study, the cells were alive and still producing insulin. As in our pancreatic cancer trials, the cells from pigs were protected from attack by the rats' immune systems; this would have undoubtedly occurred if they had not been encapsulated. In effect, we have developed a type of "artificial pancreas." This study is planned to be repeated as mentioned recently in collaboration with Dr. Eva Brandtner of VIVIT in Austria, and if successful, will lead to clinical trials in humans.
Stem cells as treatments are projected to have a market of $6.6 billion by 2016. Unfortunately, the development of treatments for many diseases using stem cells has been problematic. When "naked" (unencapsulated) stem cells are transplanted, about 50% of such transplantations fail. Stem cells typically migrate to distant locations within the body and, as a result, "abnormal" growths (including tumors), occur far from the transplantation site. Stem cells can be attacked by the body's immune system, in some cases even when encapsulated, if technology different from ours is used. Our technology has the potential to alleviate the challenges just mentioned. In our pancreatic cancer trials, encapsulated cells remained where they were implanted, were not attacked by the patients' immune systems, and survived and functioned for at least 2 years in the body without stimulating immune response toward them. Negotiations are in progress with biotech and pharmaceutical entities about using our encapsulation technology with stem cells.
The President and CEO of Nuvilex, Dr. Robert Ryan, stated, "We want to thank SmallSector.com for contacting us and interviewing Dr. Crabtree about the potential uses of our platform cell encapsulation technology in the cancer, diabetes, and stem cell areas. Due to interview time constraints, numerous other possible uses including treatments for other cancers, production of therapeutic antibodies, in the biotechnology sector, and its use with probiotic bacteria, to name but a few, were not discussed. However, through this interview we hope the investment community will be able to get a glimpse of our cell encapsulation technology and its wide array of applications."
The interview with Dr. Crabtree can be viewed at SmallSector.com.
Nuvilex, Inc. (OTCQB:NVLX) is an international biotechnology provider of live therapeutically valuable, encapsulated cells and services for research and medicine. Important advances are moving Nuvilex and its partner, Austrianova Singapore, forward. We hope to bring some of these advances to fruition in the near future. Our company's clinical offerings will include cancer, diabetes and treatments for other diseases using the company's cell and gene therapy expertise and live-cell encapsulation technology.
The Nuvilex, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/ pkgid=13494
Safe Harbor Statement
This press release contains forward-looking statements described within the 1995 Private Securities Litigation Reform Act involving risks and uncertainties including product demand, market competition, and meeting current or future plans which may cause actual results, events, and performances, expressed or implied, to vary and/or differ from those contemplated or predicted. Investors should study and understand all risks before making an investment decision. Readers are recommended not to place undue reliance on forward-looking statements or information. Nuvilex is not obliged to publicly release revisions to any forward-looking statement, reflect events or circumstances afterward, or disclose unanticipated occurrences, except as required under applicable laws.