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December 2013
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Nuvilex Readies for Late-Stage Trials as NCI Seeks New Pancreatic Cancer Drugs



National Cancer Institute Seeking a New Pancreatic Cancer Treatment as Death Rates Rise

December 20, 2013 / There may be a more optimistic future on the horizon for those afflicted by pancreatic cancer. Currently, Eli Lilly’s (LLY) Gemzar® (gemcitabine) is the only single‐agent FDA ‐ approved (in 1996) drug to treat the disease that a November article in the Journal of the National Cancer Institute stated will become the number two cause of cancer deaths in the next decade. In September, the FDA approved Celgene’s (CELG) Abraxane®, a nanoparticle formulation of albumin with the widely used anticancer drug paclitaxel (Taxol®), in combination with gemcitabine. Major reasons for the FDA approval of the Abraxane® plus gemcitabine combination included a median survival time of 8.5 months as compared to 6.7 months for gemcitabine alone and a one‐year survival rate that was increased by 59% over that seen with gemcitabine alone. Shares of Celgene have more than doubled in 2013 to $170, in part because of the approval of the Abraxane/gemcitabine combination.

What if there’s something even better than Gemzar® (gemcitabine) or Abraxane + gemcitabine?

Nuvilex, Inc. (NVLX) may be bringing that caliber of a therapeutic down its pipeline with its treatment for pancreatic cancer that is composed of the well‐known anti‐cancer prodrug ifosfamide and the cellulose‐based, live‐cell encapsulation technology for a variety of hard‐to‐treat diseases, such as cancer and diabetes. As a prodrug, ifosfamide must be converted (activated) into its cancer killing form before it is effective. The cell encapsulation technology, called “Cell‐in‐a‐Box™,” is a novel platform that puts ifosfamide‐activating cells into pin‐head‐sized, spherical capsules that are then implanted into patients with advanced, inoperable pancreatic cancer, near the pancreas and therefore the tumor itself. By activating the anti‐cancer drug very near the tumor, the cancer‐killing effects of the ifosfamide are optimized.

In Phase 1/2 clinical trials using the Cell‐in‐a‐Box™/ifosfamide combination treatment, when the results were compared with those from pivotal studies used by the FDA to approve Gemzar®, the Cell‐ in‐a‐Box™/ifosfamide combination gave a median survival time of 11 months as compared to 5.7 months for Gemzar® and a one‐year survival rate (36%) that was double that seen with Gemzar®. By comparison, as noted above, in the pivotal trial that led to the approval of Celgene’s Abraxane®/gemcitabine combination, patients treated with that combination had a one‐year survival rate that was 59% greater than that for gemcitabine and a median survival time of 8.5 months versus 6.7 months with gemcitabine alone.

If the above apparent superiority of the Cell‐in‐a‐Box™/ifosfamide combination as compared to either Gemzar® or the Abraxane®/gemcitabine combination sounds amazing, that’s because it is, particularly if one realizes that, since 1996, only two treatments have been approved by the FDA for the treatment of advanced, inoperable pancreatic cancer with the latest and best being Celgene’s Abraxane®/gemcitabine combination.

But it even gets better. Whereas serious side effects were seen in patients receiving treatment with Gemzar® or the Abraxane®/gemcitabine combination, no serious side effects were seen in patients treated with the Cell‐in‐a‐Box™/ifosfamide combination. This is because, patients in the Phase 1/2 trials with the latter combination were given ifosfamide at only one‐third of the dose normally administered when this anti‐cancer drug is used alone to treat cancers, whereas patients in the pivotal trials for Gemzar® or the Abraxane®/gemcitabine combination were given the highest doses that they could tolerate. The reduced side effect profile seen with the Cell‐in‐a‐Box™/ifosfamide treatment resulted in an overall better “quality‐of‐life” for the patients.

Nuvilex is in the midst of preparing for late‐stage trials to evaluate the Cell‐in‐a‐Box™/ifosfamide combination directly against gemcitabine, similar to what Celgene just did. If the results replicate the Phase 1/2 data and outperform not only gemcitabine, but also the Abraxane®/gemcitabine combination, whil e at the same time reducing the side effects associated with the treatment of advanced, inoperable pancreatic cancer, the days of Nuvilex trading at 12 cents per share will be a distant memory. Savvy biotech investors know that the time to invest is before clinical data arrives in order to catch the full breadth of a move, particularly if positive top‐line results are delivered, meaning that now, not later, is the time to be taking a close look at Nuvilex, Inc. (NVLX) and its acquisition of the rights to use a unique live‐cell encapsulation technology that could revolutionize treatments for pancreatic cancer as well as other deadly diseases.


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