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Nuvilex, Inc. Designing Protocol for Its Next Pancreatic Cancer Trial

BALTIMORE, MD--(Marketwired - Sep 23, 2013) - In a newly released article, Goldman Small Cap Research, a stock market research firm focused on the small cap and micro cap sectors, notes that based on recent news, it is clear that Nuvilex, Inc. ( OTCQB : NVLX ) management is working on the design of a protocol for its next pancreatic cancer trial. A protocol is akin to an owner's manual or set of procedures that lays out in detailed form the guidelines for the initiation, conduct and administration of a clinical trial.

Recent Nuvilex contract news seem to indicate that the next trial will have 100 or more subjects (pancreatic cancer patients) in multiple sites around the globe, with those sites and administering clinicians and local investigators to be determined by Nuvilex. Of course, a Clinical Research Organization (CRO) will be tapped to prepare for and run the trial as well, which is an extremely critical function. All parties involved in conducting the trial must strictly adhere to all parameters set out in the clinical protocol that will define the entire clinical trial design and will clearly state the primary and secondary objectives of the study.

It is a bit early to forecast, but Goldman Small Cap Research believes that the best way for Nuvilex to design the trial would be a randomized, double-blind, multiple arm, multiple site study. Some patients will be enrolled in the Nuvilex arm, which means these patients will be treated with the prodrug, ifosfamide, and the encapsulated live ifosfamide-activating cells, while in the other arm, a comparator, patients will be treated with Gemzar, which will be used as a single agent therapy. By having a double blind-trial, no one will know until the trial is over, which patients received which treatment. Median survival time and one-year survival rate will be the likely principal objectives of the Phase 3 trial, as they were in the Phase 2 trials.

Considering that the results of the Company's Phase 2 trials were better in terms of median survival time and one-year survival rate than those reported for the 3 approved pancreatic cancer treatments, Gemzar (gemcitabine), the combination of gemcitabine with Tarceva (erlotinib), and the combination of gemcitabine with Abraxane (albumin-bound paclitaxel) in their Phase 3 trials, if Nuvilex were to repeat its previous results in a Phase 3 trial, the Company would likely be the oncology treatment story and stock of the year.

This press release contains excerpts of our most recent published article on Nuvilex. To view all of our sponsored Nuvilex reports, updates, articles, disclosures and disclaimers, or to download the article in its entirety, please visit www.goldmanresearch.com.

About Goldman Small Cap Research: Led by former Piper Jaffray analyst and mutual fund manager Rob Goldman, Goldman Small Cap Research produces sponsored and non-sponsored small cap and micro cap stock research reports, articles, daily stock market blogs, and popular investment newsletters. Goldman Small Cap Research is not in any way affiliated with Goldman Sachs & Co.

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About Nuvilex, Inc. ( OTCQB : NVLX ): Nuvilex, Inc. is an international biotechnology firm focused on developing and preparing to commercialize treatments for cancer, diabetes and other diseases based on the live, therapeutically valuable, encapsulated cells platform. The Company is leveraging its cancer biology and clinical oncology research experience and expertise, particularly for use in oncology treatments, in addition to initiating oncology applications of medical marijuana. For more information visit: www.nuvilex.com.