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MICROCAP HOT TOPICS
 

July 1, 2013

Breast Cancer Patients Need Nuvilex

The past 2 weeks have been a mixed bag for those following breast cancer treatments and funding.  As a result, it seems apparent that the space could use some good development news. While new product development isn’t around the corner for Nuvilex, Inc. (OTCQB – NVLX - $0.105 – Spec Buy), the Company’s positioning and prospects in its breast cancer therapy studies remain outstanding. Moreover, as further research studies are conducted, it is likely that the Firm’s live-cell encapsulation therapy will become a high profile proposition.

Each year, over 200,000 women in the U.S are diagnosed with breast cancer and over 40,000 deaths are caused by the disease. These large numbers, combined with the high rate of survivability and organizations founded to fight the disease and support current patients have arguably made breast cancer the highest profile of all cancers. Therefore, it is troubling that some of the biggest stories in breast cancer of late have nothing to do with treatment development success.

Instead, breast cancer patients have been treated with word that Hollywood starlet Angelina Jolie recently underwent a double mastectomy as a preventive measure, prompting many at-risk women to consider the same procedure. While Ms. Jolie’s admission is noble and admirable, the American Cancer Society has urged caution against such surgeries, especially given that the risk of developing cancer may not be eliminated.

Separately, it has come to light that the executive director of the Susan G. Komen Foundation, which is the ubiquitous non-profit sponsor of events to raise funds in order to fight breast cancer, has earned a very high salary despite substantial declines in fundraising, which has given the organization a black eye. These unusual stories unfortunately divert attention away from very promising therapies such as the one being developed by Nuvilex.  Clearly, those patients potentially at risk for the disease would prefer that new treatment options under development be at the forefront of the space rather than soap opera-type of news stories.

Nuvilex affiliate SG Austria conducted Phase I/II clinical trials in dogs with spontaneously occurring mammary tumors; this animal model is closely related to the development of breast cancer in humans. Results of the study were remarkably similar to its well-known human Phase II pancreatic cancer trial. For example, greater degrees of tumor shrinkage were observed in those dogs treated with encapsulated pro-drug-activating cells as well as the pro-drug cyclophosphamide versus those receiving cyclophosphamide alone.  In the case where two spontaneous mammary tumors grew in the same animal, one tumor was treated with cyclophosphamide alone and the other was treated with the encapsulated cell/cyclophosphamide combination.  The combination treatment resulted in 70% tumor shrinkage as compared to the 20% shrinkage seen with the drug alone.

It is evident that the results of this animal trial could lead to a future human breast cancer clinical trial using the Company’s live-cell encapsulation platform, which should be viewed as a major development given the different approach engaged by Nuvilex, along with its results, as compared with current therapies.  The bottom line is that the Company’s 2 trials clearly illustrate the great potential efficacy in using encapsulated cells with a pro-drug as a targeting device for the treatment of solid pancreatic and mammary tumors, which will substantially raise Nuvilex’s profile and valuation.

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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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