Written by ι Stock Market Media Group Staff — August 22, 2013
While Eli Lilly’s (NYSE: LLY) cancer fighting drug Gemzar (gemcitabine) has been on the market since the late 1990s, its success with cancer duly noted, other big pharmaceutical companies are combining their own drugs with gemcitabine in their own clinical trials in an attempt to improve upon the gemcitabine’s effectiveness when that drug is used alone for the treatment of advanced, inoperable pancreatic cancer, but they’re not finding much success. However, Nuvilex, Inc.’s (OTCQB: NVLX) treatment for the disease has shown better data in two mid-phase clinical trials when compared to historical data for gemcitabine alone.
It’s enough to make one ask, when is big pharma going to turn to Nuvilex to improve their own clinical trials?
Last year, Infinity Pharmaceuticals (NASDAQ: INFI), with its almost one-billion dollar market cap, halted a mid-stage clinical trial it was involved with to develop a new pancreatic cancer drug. In that trial, Infinity used its drug saridegib in combination with gemcitabine in hopes of improving upon the survival rates produced by gemcitabine alone. When data showed patients weren’t living longer, but instead less with the combination than with gemcitabine alone, Infinity halted its trials and its shares fell more than 30% on the news.
Nuvilex is a biotech firm using a unique and proprietary cellulose-based live-cell encapsulation technology as part of its treatment for advanced, inoperable pancreatic cancer. The company has combined that technology with the cancer killing drug ifosfamide in two independent Phase II clinical trials – both of which showed that the company’s treatment outperformed Eli Lilly’s Gemzar when the trial data was compared with historical data for gemcitabine.
Gemzar is the only drug approved by the FDA as a single agent for the treatment of advanced, inoperable pancreatic cancer and the drug is considered the “gold standard” by the market.
Even Celgene Corp.’s (NASDAQ: CELG) large scale Phase III clinical trials, which have been viewed as successful, fell short of the survival rates produced in Nuvilex’s two clinical trials. NASDAQ’s Celgene took an interesting approach when it used Bristol-Myers Squibb’s (NYSE: BMY) drug, Taxol in a nanoparticle formulation with albumin (this Taxol formulation is known as Abraxane) in combination with gemcitabine to improve upon the survival rates of gemcitabine alone. In those trials, where the gemcitabine-Abraxane combination was compared head to head with gemcitabine alone, Celgene only saw an increase of 1.8 months in median survival time and only about a 58% increase in the one-year survival rate for patients treated with the combination of Abraxane plus gemcitabine when compared to gemcitabine alone.
By comparison, for Nuvilex’s treatment, a substantial response was seen in that the use of the live-cell encapsulation-ifosfamide combination helped patients to a far better outcome than that previously reported with standard single-drug Gemzar. Those results included, an increase of about 4 months in median survival time and a 100% increase in the one-year survival rate as compared to gemcitabine.
The question now is, will Infinity Pharmaceuticals keep a pancreatic cancer treatment in its pipeline or will it abandon that work altogether. With so many other big pharmaceutical companies so content to use gemcitabine, it grows even clearer that with a successful Phase III trial, Nuvilex will get a great deal of attention, especially now that it owns exclusive worldwide licenses associated with the live-cell encapsulation-based pancreatic cancer treatment. These are rights that other companies could have made a play for had they paid closer attention to the data produced using the technology as compared to even their own trial results.