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Nuvilex's Pancreatic Cancer Treatment Readies To Challenge Eli Lilly and Company (LLY) And Celgene (CELG) In Late-Phase Clinical Trials



2/19/2014 10:14:43 AM

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NEW YORK, NY--(Marketwired - February 19, 2014) - Nuvilex, 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.

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