Written by ι Stock Market Media Group Staff — December 16, 2013
Nuvilex, Inc. (OTCQB: NVLX) may be just what the National Cancer Institute (NCI) and a growing number of doctors ordered – the company’s late stage clinical trials in advanced, inoperable pancreatic cancer that is. In an editorial that accompanied the findings of an epidemiological study of patients with pancreatic cancer published in the November 20 issue of the Journal of the National Cancer Institute (JNCI), treatments using the drug gemcitabine for the disease were put on notice and treatments not using gemcitabine alone or in combination with another drug as a treatment are being sought. Nuvilex has just such a treatment ready for late-phase clinical trials.
In that editorial, Dana Cardin, MD, MSCI, and Jordan Berlin, MD, from the Vanderbilt-Ingram Cancer Center at Vanderbilt University Medical Center in Nashville, Tennessee, stated that more effective therapies will be needed to stem the rising tide of pancreatic cancer. This editorial is good news for Nuvilex in that both doctors agree with a 2007 NCI sponsored “state of the science” meeting that called for “a need to abandon the mindless propagation of the ‘gemcitabine vs gemcitabine + your drug here’ design used for over a decade in late-stage pivotal clinical trials.”
Eli Lilly’s (NYSE: LLY) pancreatic cancer drug Gemzar® or gemcitabine has been the single-agent “gold standard” for the treatment of the disease since the FDA approved it back in 1996, but just this year the FDA approved Celgene’s (NASDAQ: CELG) Abraxane® (a nanoparticle formulation of the widely used drug Taxol with albumin) in combination with gemcitabine as the new treatment of choice for those with advanced, inoperable pancreatic cancer.
However, the NCI, and now both Drs. Cardin and Berlin, are calling for a solution that does not use gemcitabine as part of the treatment for the disease in hopes of improving median survival time over those seen with Eli Lilly and Celgene’s treatments.
As the calls grow louder for a better treatment, Nuvilex’s COO, Dr. Gerry Crabtree says count his company in the hunt for a shot at a better solution. “The article in JNCI coupled with the comments by Drs. Cardin and Berlin highlight both the alarming increase in the incidence of pancreatic cancer and the paucity of new effective treatments for it since Gemzar® was approved in 1996, as well as the fact that the treatments approved by the US FDA since then combine a new drug with gemcitabine. With all of these factors in mind, Nuvilex may be in the ‘right place at the right time,’ as it prepares for late-phase clinical trials with its pancreatic cancer treatment that does not depend on gemcitabine for part of its efficacy.”
Nuvilex has presented data from two independent early-mid phase clinical trials using a treatment that does not include gemcitabine and that improves the median survival time as well as the one-year survival rate over those seen with Gemzar® or gemcitabine plus Abraxane®. Instead, Nuvilex will enter late-phase clinical trials in pancreatic cancer using the Cell-in-a-Box™ technology in combination with the well-known anti-cancer prodrug ifosfamide as a treatment for the disease.
Nuvilex recently hosted three days of meetings with its officers and Board of Directors, as well as principals from SG Austria and Austrianova Singapore, the developers of the Cell-in-a-Box™ cellulose-based live-cell encapsulation technology, the rights to which were recently acquired by Nuvilex for use in developing treatments for all forms of cancer, and which is part of Nuvilex’s treatment for advanced, inoperable pancreatic cancer. In those meetings, you can bet this new call for a better treatment than both Eli Lilly and Celgene offer was discussed.
Also, in those meetings, particular emphasis was placed on the progress of preparations for the company’s late-phase clinical trials in pancreatic cancer. At Nuvilex’s current entry price, the investment community should have the biotech on its radar, especially given this call by both the NCI and Drs. Cardin and Berlin for a treatment such as that being developed by Nuvilex that seems to meet the requirements espoused by these entities for a better treatment for this devastating and deadly disease – Nuvilex is on the doorstep of entering late-phase clinical trials to prove just that.