Investment and Company Research
Opportunity Research
HOT TOPICS
 

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.

You Might Also Like

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. 

Disclaimer
This Opportunity Research Hot Topics article was prepared for informational purposes only. Goldman Small Cap Research, (a division of Two Triangle Consulting Group, LLC) produces research via two formats: Goldman Select Research and Goldman Opportunity Research. The Select product reflects the Firm’s internally generated stock ideas while the Opportunity product reflects sponsored research reports. It is important to note that while we may track performance separately, we utilize the same coverage criteria in determining coverage of all stocks in both research formats. While stocks in the Opportunity format may have a higher risk profile, they typically offer greater upside as well. Since April 2012, Goldman Small Cap Research has been compensated $500 per article by a third party.  All information contained in this report was provided by the Company or derived from GSCR due diligence. Our analysts are responsible only to the public, and are paid in advance to eliminate pecuniary interests, retain editorial control, and ensure independence. Analysts are compensated on a per report basis and not on the basis of his/her recommendations.

The information used and statements of fact made have been obtained from sources considered reliable but we neither guarantee nor represent the completeness or accuracy. Goldman Small Cap Research did not make an independent investigation or inquiry as to the accuracy of any information provided by the Company, or other firms. Goldman Small Cap Research relied solely upon information provided by the Company through its filings, press releases, presentations, and through its own internal due diligence for accuracy and completeness. Such information and the opinions expressed are subject to change without notice. A Goldman Small Cap Research report, update, article, or note is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed.

This publication does not take into account the investment objectives, financial situation, or particular needs of any particular person. This report does not provide all information material to an investor’s decision about whether or not to make any investment. Any discussion of risks in this presentation is not a disclosure of all risks or a complete discussion of the risks mentioned. Neither Goldman Small Cap Research, nor its parent, is registered as a securities broker-dealer or an investment adviser with FINRA, the U.S. Securities and Exchange Commission or with any state securities regulatory authority.

ALL INFORMATION IN THIS REPORT IS PROVIDED “AS IS” WITHOUT WARRANTIES, EXPRESSED OR IMPLIED, OR REPRESENTATIONS OF ANY KIND. TO THE FULLEST EXTENT PERMISSIBLE UNDER APPLICABLE LAW, TWO TRIANGLE CONSULTING GROUP, LLC WILL NOT BE LIABLE FOR THE QUALITY, ACCURACY, COMPLETENESS, RELIABILITY OR TIMELINESS OF THIS INFORMATION, OR FOR ANY DIRECT, INDIRECT, CONSEQUENTIAL, INCIDENTAL, SPECIAL OR PUNITIVE DAMAGES THAT MAY ARISE OUT OF THE USE OF THIS INFORMATION BY YOU OR ANYONE ELSE (INCLUDING, BUT NOT LIMITED TO, LOST PROFITS, LOSS OF OPPORTUNITIES, TRADING LOSSES, AND DAMAGES THAT MAY RESULT FROM ANY INACCURACY OR INCOMPLETENESS OF THIS INFORMATION). TO THE FULLEST EXTENT PERMITTED BY LAW, TWO TRIANGLE CONSULTING GROUP, LLC WILL NOT BE LIABLE TO YOU OR ANYONE ELSE UNDER ANY TORT, CONTRACT, NEGLIGENCE, STRICT LIABILITY, PRODUCTS LIABILITY, OR OTHER THEORY WITH RESPECT TO THIS PRESENTATION OF INFORMATION.