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Nuvilex, Inc. Could Obtain FDA Accelerated Approval After Phase 2b Clinical Trial

Nuvilex, Inc. Could Obtain FDA Accelerated Approval After Phase 2b Clinical Trial

Written by ι Stock Market Media Group Staff — April 17, 2014

Nuvilex, Inc. (OTCQB: NVLX) has once again delivered a major announcement as it advances its pancreatic cancer treatment toward late phase clinical trials. Nuvilex continues to put forth what is turning into a well thought out game plan for the future of treating advanced pancreatic cancer. It’s a game plan that could include obtaining accelerated FDA approval of its pancreatic cancer treatment if it can produce the same strong results in an announced Phase 2b clinical trial that were produced in two separate Phase 1/2 trials using the combination of the Cell-in-a-Box® technology with the anticancer drug ifosfamide.

The market may want to start connecting the dots with this international biotech because as Nuvilex releases each piece of its story, the path is leading to more and more impressive hands guiding Cell-in-a-Box® and Nuvilex right to the FDA’s door. In fact, given pancreatic cancer is so deadly, it could be sooner rather than later that the medical community becomes familiar with the company in one form or another.

Nuvilex just named Clinical Network Services Pty Ltd (CNS) as its Contract Research Organization (CRO) for late phase trials. Yes, this is the same CNS that successfully took the Cell-in-a-Box® technology combined with ifosfamide through Phase 1 & 2 clinical trials. Well, now the two entities will join forces on a Phase 2b trial or what some call a “miniature Phase 3 trial.” This two-arm study will see Nuvilex’s treatment going head to head with Celgene’s (NASDAQ: CELG) treatment of Abraxane® plus gemcitabine.

What investors may not realize is that through the FDA’s Accelerated Approval Program, Nuvilex could receive FDA approval of its pancreatic cancer treatment using Phase 2b data. If CNS can once again lead the combination of Cell-in-a-Box® with ifosfamide to the same powerful results it generated in prior trials that still today outperform Eli Lilly’s (NYSE: LLY) Gemzar® and Celgene’s treatment, the FDA could grant accelerated approval for the treatment. This program is one of several tools used by the FDA to expedite the approval of medicines intended to treat serious or unmet needs.

Two months ago in February 2014, Chelsea Therapeutics International announced that the FDA granted accelerated approval of NORTHERA™ (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH).

Three months ago in January 2014, the FDA approved GlaxoSmithKline’s Mekinist (trametinib) under the accelerated approval program for use in combination with Tafinlar (dabrafenib) as a possible treatment for patients suffering from inoperable melanoma and certain types of metastatic melanoma.

Five months ago in November 2013, the FDA granted accelerated approval to Pharmacyclics, Inc.’s Ibrutinib (IMBRUVICA) for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

The FDA’s Accelerated Approval Program allows for the approval of an investigational drug or treatment based on a surrogate endpoint (a measurement that can “stand in” for an accepted measurement of disease progression) in early-phase studies if the condition is serious or life-threatening, and Nuvilex should have an excellent case for just such an approval.

If that were to happen, the company may or may not be required to conduct a Phase 3 trial while its treatment is being used by patients with advanced, inoperable pancreatic cancer. It would, however, undergo a Phase 4 or “confirmatory study” to further evaluate and confirm the efficacy and safety of the treatment, but it would do so with Cell-in-a-Box® combined with ifosfamide on the market.