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Nuvilex, Inc.’s Phase III Pancreatic Cancer Trials Could Address New Law’s Call for Progress

Nuvilex, Inc.’s Phase III Pancreatic Cancer Trials Could Address New Law’s Call for Progress

Written by ι Stock Market Media Group Staff — June 24, 2013

Nuvilex, Inc. (OTCQB: NVLX) has a great opportunity to demonstrate and showcase its encapsulation technology in its upcoming Phase III clinical trials for the treatment of late stage, inoperable pancreatic cancer.  There will be plenty of interested observers, and you can bet that those US Senators and Congressmen responsible for the Recalcitrant Cancer Research Act that was signed into law earlier this year, will be among them.

Nuvilex’s upcoming late stage trials could be just what this Act is striving for – a more successful treatment than the current standard, and a sign of progress against pancreatic cancer.  Originally introduced as the Pancreatic Cancer Research and Education Act, the Recalcitrant Cancer Research Act became law on January 2, 2013, as part of the National Defense Authorization Act.  The law calls on the National Cancer Institute (NCI) to develop scientific frameworks that will help provide the strategic direction and guidance needed to make true progress against pancreatic and lung cancers by July 2014. 

Under the statute, the NCI Director may also develop scientific frameworks for other deadly or recalcitrant cancers, defined as those with a five-year relative survival rate below 50 percent.  Nuvilex, of course, is heavily invested in pancreatic cancer research.  Pancreatic cancer is one of the deadliest cancers with only a five-year survival rate of just 6%.  Survival rates for pancreatic cancer have remained in the single digits for nearly forty years.

 Dr. Gerald Crabtree, Nuvilex’s COO stated “This new Act serves to shine a spotlight on the still evident devastating and deadly nature of pancreatic cancer, particularly when it is at an advanced stage and when it is inoperable, and the fact that improvements in its treatment over the past few years have been relatively minor.  We at Nuvilex fervently hope that, if successful, our live-cell encapsulation-based treatment will be a quantum leap forward in the satisfactory treatment of this disease.”

According to the Pancreatic Cancer Action Network, the underlying bill, the Pancreatic Cancer Research and Education Act, was first introduced because we are not making significant scientific progress in the treatment of pancreatic cancer, and the consequences are deadly.  Dr. Daniel Von Hoff, MD, Physician-in-Chief and Distinguished Professor at the Translational Genomics Research Institute in Scottsdale, Arizona, and a consultant to Celgene, Corp. (NASDAQ: CELG) on its pancreatic cancer trials, agrees that we need better treatments.

Dr. Von Hoff has noted “The past few decades have brought us very few treatment advances for patients with advanced pancreatic cancer.  I have counted 33 phase III trials since 1990, and only 3 were positive.  This has been a frustrating area.”

Dr. Von Hoff presented Celgene Corp.’s results from its large scale phase III trial at the 2013 Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO), held in San Francisco.  Celgene’s trial compared their treatment, which consisted of the combination of nanoparticle-albumin-bound (nab)-paclitaxel (Taxol), or Abraxane, plus gemcitabine (Gemzar) to gemcitabine alone.

Currently, Eli Lilly’s (NYSE: LLY) Gemzar (gemcitabine) is the only drug approved by the FDA as a single agent for the treatment of advanced pancreatic cancer, and is the current “gold standard” for the disease.

Median survival time for patients treated with a combination of Abraxane plus gemcitabine was 8.5 months vs. 6.7 months for gemcitabine alone – an increase of 1.8 months or almost a 30% increase. 

One-year survival rate obtained with the Abraxane plus gemcitabine combination showed an increase of 59% over the results seen with gemcitabine alone.

While these numbers improve upon the current single-drug standard, Nuvilex has produced even better data in its two independent Phase II trials.  Using its cell encapsulation technology combined with the anticancer drug ifosfamide, the median survival time and the one-year survival rate of patients were approximately doubled when compared to previously reported data for Gemzar.

A recent report issued by the Pancreatic Cancer Action Network, found that by 2020, pancreatic cancer is expected to become the second leading cause of cancer death in the United States.  Both Celgene and Nuvilex are stepping up with impressive trials that should help to inject some confidence into the debate that a better treatment can make its way to market.