New York, NY- September 05, 2014 - InvestorsHub NewsWire - Nuvilex, Inc. (OTCQB: NVLX) has used the last two weeks to further solidify its position as a biotechnology firm, and to further its treatment for advanced pancreatic cancer, as well as, other abdominal cancers.  This summer has been a starting line, of sorts, for Nuvilex to begin making the case that Cell-in-a-Box® should help it become a competitor in the cancer market.

Just this week Nuvilex announced that it has officially applied for the Orphan Drug Designation with the European Medicines Agency (EMA) for its treatment for advanced pancreatic cancer, and that it also plans to apply for the Orphan Drug status in the US and Australia among other markets.

The company expects to enter late phase clinical trials in early 2015 where it will use its treatment of Cell-in-a-Box combined with low doses of the anticancer drug ifosfamide, to go head-to-head with Celgene’s (NASDAQ: CELG) treatment of Abraxane® plus gemcitabine, the current gold standard for advanced pancreatic cancer.

In two earlier Phase I/II clinical trials, the treatment of Cell-in-a-Box/ifosfamide produced better survival times than both Celgene’s treatment and Eli Lilly’s (NYSE: LLY) single agent treatment of gemcitabine.

If Nuvilex should receive Orphan Drug status, the company would enjoy 10 years of marketing exclusivity for the Cell-in-a-Box/ifosfamide combination along with special assistance with the development process of the company’s treatment, and exemptions or reductions in regulatory fees from the EMA.

The Orphan Drug Designation is awarded to drugs or treatments for “rare,” life-threatening diseases.  In Europe, a rare disease is defined as one that occurs in less than 5 of every 10,000 people.  Pancreatic cancer certainly meets the criteria in Europe and in the US for that matter, and the treatment has previously received the Orphan Drug Designation in Europe, so the company should receive the status.

In another major announcement two weeks ago, Nuvilex stated that it and Translational Drug Development (TD2) officially began the first of 4 different pre-clinical studies that will determine what effect the company’s pancreatic cancer treatment will have on symptoms associated with abdominal cancers.

Nuvilex’s first pre-clinical study will test the success of the Cell-in-a-Box/ifosfamide combination in slowing the accumulation of malignant ascites fluid in cancer patients.  Malignant ascites is the abnormal accumulation of abdominal fluid due to the direct effects of cancer, and the fluid itself can contain cancerous cells, which, in turn, can “seed” at various places in the abdomen and form new tumors.

According to the National Cancer Institute, the prognosis for patients with malignant ascites is poor, so this first study could draw a great deal of attention if successful.
The World Cancer Research Fund’s latest statistics regarding what are called “abdominal cancers” show that annually there are nearly 1.7 million new cases of breast cancer diagnosed, 1.4 million new cases of colorectal cancer, 952,000 new cases of stomach cancer, 782,000 new cases of liver cancer, 338,000 new cases of pancreatic cancer and 239,000 new cases of ovarian cancer.  Each of these new cases will potentially need a treatment for the symptoms they will experience.

These are just a few of the abdominal cancers, and as should be obvious by the 5.4 million new cases they represent annually, Nuvilex is potentially developing a treatment that could compete in what is a huge and virtually untapped symptoms market.

Given there is only a mean survival time of less than 4 months for those patients suffering from malignant ascites (depending on the type of malignancy), and TD2’s reputation for success, Nuvilex and its investors could see this past summer as the official start of a very bright future.
 
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