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June 17, 2013

High Median Survival Rate is Nuvilex’s Trump Card

If one strips out all of the information regarding its live-cell encapsulation platform to treat pancreatic cancer and focuses on key data, it is easy to see that Nuvilex Inc. (OTCQB – NVLX - $0.11 – Spec Buy) has a real trump card: High Median Survival Rate and Overall Survival. At the end of the day, given that there is no cure for pancreatic cancer, the key endpoint and objective on behalf of patients given various therapies and treatments is to increase the amount of time a patient treated with therapy will survive as a result of the treatment.  To be frank, one of the primary reasons why anti-cancer drugs are so expensive is that we are willing to pay whatever it takes for our loved ones to live as long as possible despite being stricken with pancreatic cancer.

From an outsider’s perspective, the data appears weak. Perhaps this is why even fair results are led with cheers and adulation. In fact, since 1990 there have been 33 Phase III trials in this arena, and only 3 were positive. From all of this work, the current gold standard and only approved treatment that is used today, Gemzar®, has demonstrated a one year survival rate of 18% and a median overall survival rate of 25 weeks or 6.7 months.  Conversely, ABRAXANE®, developed by Celgene (NYSE – CEG), released its Phase III results in early 2013 to much fanfare.  Celgene hoped to show that the combination of its chemotherapy drug ABRAXANE with Gemzar® would improve overall survival in patients with untreated, metastatic pancreatic adenocarcinoma when compared to gemcitabine alone.

The supporting data was released on January 22, 2013 by Celgene, showing that overall survival increased by nearly two months (8.5 vs. 6.7) in patients who received the combination treatment. Plus, a 59% increase in one-year survival was also reported. This information suggests that ABRAXANE plus gemcitabine is a safe and effective treatment option for patients with untreated metastatic pancreatic adenocarcinoma.

This data illustrates an improvement in the key survival objectives which are similar to Nuvilex’s Phase II trials. In the Nuvilex Phase II pancreatic cancer trials in which its technology was used to encapsulate live cancer-drug-activating cells which were then implanted near the pancreas and therefore the tumor, the anticancer drug ifosfamide was administered.  Herein lies the critical Nuvilex punch: the difference still hides in future trials since patients in the completed Phase II Nuvilex trials were only treated twice compared to six or more in other trials completed or ongoing. The Nuvilex results showed median survival nearly doubled (40 weeks vs. 25 weeks [or you can say 9.2 vs. 6.7 months) and one-year survival doubled from 18% to 36%, as compared to historical data for Gemzar® mentioned earlier, the only drug approved to date by the FDA as a single agent for the treatment of advanced inoperable pancreatic cancer.

For those keeping score, Celgene’s lauded drug increased overall survival by 27%, while Nuvilex increased median survival by nearly 100%. The one-year survival rate was increased by 59% for Abraxane and 100% for Nuvilex’s encapsulated cells plus low-dose ifosfamide.  ABRAXANE® has been approved for other cancers and the data is from a Phase III trial, but the data still aren’t all in since if Nuvilex were to generate its previous results in a late Phase II or Phase III trial, the Company would likely be the oncology treatment story of the year.

Senior Analyst: Robert Goldman
Rob Goldman has over 20 years of investment and company research experience as a senior research analyst and as a portfolio and mutual fund manager. During his tenure as a sell side analyst, Rob was a senior member of Piper Jaffray's Technology and Communications teams. Prior to joining Piper, Rob led Josephthal & Co.'s Washington-based Emerging Growth Research Group. In addition to his sell-side experience Rob served as Chief Investment Officer of a boutique investment management firm and Blue and White Investment Management, where he managed Small Cap Growth portfolios and The Blue and White Fund.

Analyst Certification
I, Robert Goldman, hereby certify that the view expressed in this research report accurately reflect my personal views about the subject securities and issuers. I also certify that no part of my compensation was, is, or will be, directly or indirectly, related to the recommendations or views expressed in this research report. 

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