By Dr. Joseph Rubinfeld, Chief Scientific Advisor
A Three Part Article on the Accomplishments of 2009
and the Potential of 2010 and Beyond
Part One: More Than Just Generex Oral-lyn(TM) --
Generex Has Other Programs With Blockbuster Potential
WORCESTER, Mass., Jan. 6, 2010 (GLOBE NEWSWIRE) -- With over 40 years experience in the rollercoaster ride of drug development and commercialization, I have been fortunate to have been one of the founders and leaders of a number of multi-billion dollar ventures, including the development of amoxicillin, as well as the founding of Amgen Inc. and SuperGen, Inc. And now, as I have taken on the role of Chief Scientific Advisor for Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com) and am preparing a white paper on the significant proprietary scientific technologies amassed by this still relatively unknown biotechnology company, I feel it is important to reflect on the pivotal year of 2009 which has set the stage for what I believe is an important future in numerous areas.
The collapse of the financial markets in 2008 left the biotechnology world in disarray with sources of capital all but disappearing overnight. This placed many small companies completely reliant on capital financing on the verge of bankruptcy and Generex was no exception. However, through the coordination of efforts of management and a team of new advisors to the company, Generex was able to retire onerous debt and raise traditional capital through a series of common stock offerings at progressively higher prices throughout 2009. Today, Generex has a significant amount of capital to deliver exceptional results and while most people focus on Generex Oral-lyn(TM), the company's buccall insulin spray product (and for good reason as it recently received approval for the use under the USFDA's Treatment Investigational New Drug program), what is often overlooked are two other very promising drug programs with vast market potential.
In 2003, Generex acquired Antigen Express, Inc., a fledgling biotech company with a number of novel early-stage opportunities. In 2009 we began to see a path to success as the science we acquired has begun to move through the clinical trial process for two potential blockbuster immunotherapeutic vaccine technology programs. First, and furthest along, is its immunotherapeutic synthetic vaccine technologies for cancers (breast, cervical, and prostate). Positive Phase II results for its breast cancer vaccine in 2009 have enabled the company to make preparations for a Phase III study which we hope to commence some time in calendar 2010. According to the National Cancer Institute, over 250,000 women were diagnosed with some form of breast cancer in 2009, and it is the second leading cause of cancer death among women. While this represents a substantial market opportunity for Generex, more importantly, the potential benefit for the millions of women throughout the world prone to breast cancer is staggering and after all, the true goal of every scientist in biotechnology, along with the business opportunity, is to better the life of people suffering from illness. I am pleased to be a part of this important effort at Generex.
About Generex Biotechnology Corporation
Generex is engaged in the research, development and commercialization of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(TM) device. The Company's flagship product, oral insulin (Generex Oral-lyn(TM)), which is available for sale in India, Lebanon, Algeria, and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.
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Safe Harbor Statement
This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects," or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.