Nuvilex Eyes FDA Fast Track After ABRAXANE Approved for Pancreatic Cancer

NEW YORK, NY--(Marketwired - Sep 11, 2013) - Nuvilex, Inc. (OTCQB: NVLX) and its shareholders enjoyed what could be a dress rehearsal of their own future with the Food and Drug Administration's (FDA) Fast Track program. Late last week Celgene announced that the FDA has approved its supplemental new drug application for ABRAXANE® when used in combination with gemcitabine as first-line treatment for late-stage, metastatic pancreatic cancer.

The FDA reviewed the new use for ABRAXANE under the agency's priority review program which provides for an expedited review of drugs. ABRAXANE, a form of the chemotherapy drug paclitaxel (TAXOL®) modified by the addition of a human protein called albumin, was also granted the orphan drug designation for pancreatic cancer because it is intended to treat a rare disease or condition.

Nuvilex's COO, Dr. Gerry Crabtree, says his company also plans to apply to have the FDA "Fast Track" its unique live-cell encapsulation-based treatment for advanced, inoperable pancreatic cancer that consists of tiny pin-head-sized capsules containing live drug-activating cells combined with the long known and widely used cancer drug, ifosfamide, once the biotech enters its future late-stage clinical trials. And, there is no reason to believe that Nuvilex wouldn't also be granted the FDA designation if it can continue to confirm the data the company has seen in its two independent Phase II clinical trials.

According to the FDA, "Fast Track" is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need in the treatment of serious or life-threatening conditions. The purpose is to get important new drugs to the patient earlier than would otherwise be the case. According to the American Cancer Society, pancreatic cancer is the fourth leading cause of cancer death in the U.S., and this year an estimated 45,220 patients will be diagnosed and 38,460 will die from the disease.

Dr. Crabtree feels, just as Celgene's ABRAXANE, his company's treatment fits the definition for the Fast Track designation for its treatment, "Because the survival of patients with advanced pancreatic cancer is so very short, in spite of the most aggressive treatment, we will seek 'Fast Track' status from the various regulatory authorities because our treatment will, if successful, fill an unmet medical need. If this is granted, the time taken for the entire drug approval process by regulatory authorities will be significantly shortened."

The FDA says that most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review. A Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. A Priority Review means that the time it takes the FDA to review a new drug application (NDA) for ultimate marketing approval is reduced.

As noted, in addition to the Fast Track designation, ABRAXANE was granted orphan drug status by the FDA for its use, in combination with gemcitabine, in treating pancreatic cancer. In the US, orphan drug status carries with it 7-years of marketing exclusivity, after FDA approval, for the company or entity that develops the drug.

In Europe, as a consequence of a drug receiving the orphan drug designation, the period of marketing exclusivity after approval is 10 years. In the past, the EMEA or EMA (FDA's equivalent in Europe) has designated the capsules together with the drug-activating cells within them (part of Nuvilex's pancreatic cancer treatment) as an orphan drug.

The combination of ABRAXANE with gemcitabine improved overall survival in patients with metastatic pancreatic cancer by 1.8 months (8.5 months vs. 6.7 months) when compared with gemcitabine alone during Celgene's phase III clinical trial. Also, results showed that the ABRAXANE-gemcitabine combination gave a 59% increase in one-year survival rate over that seen with gemcitabine alone.

Armed with that data, Celgene was granted Fast Track status, and Priority Review. The good news for Nuvilex shareholders is that in two independent Phase II clinical trials, the company's pancreatic cancer treatment helped patients to a far better outcome -- 4 months in median survival time over standard single-drug gemcitabine alone versus the 1.8 months seen with the newly FDA approved ABRAXANE-gemcitabine combination. 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. If Nuvilex can duplicate this data, Celgene's reign will be short lived.

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