By Dr. Joseph Rubinfeld, Chief Scientific Advisor
A Three Part Article on the Accomplishments of 2009
and the Potential of 2010 and Beyond
Part Two: Generex and the Treatment of Diabetes --
the Generex Oral-lyn(TM) Opportunity
WORCESTER, Mass., Jan. 7, 2010 (GLOBE NEWSWIRE) -- When examining the science at Generex, one need not look any further than the treatment of diabetes to understand the vast potential of its proprietary drug delivery system and its flagship buccal insulin spray product, Generex Oral-lyn(TM). While I believe the true value of this drug delivery system is largely overlooked, it is easy to focus on its use for the treatment of Type 1 and Type 2 diabetes mellitus. In the United States alone, the American Diabetes Association estimates that 7.8% of the population (approximately 24 million people) has some form of diabetes. Additionally, there are over 1.6 million new cases of diabetes diagnosed each year. It is the seventh leading cause of death in the U.S. and leads to a host of related illnesses, including heart disease. The annual direct medical cost of diabetes in the U.S. was estimated to be over $116 billion in 2007.
As with any disease, the treatment for diabetes depends on its severity with each patient. The generally accepted treatment for Type 2 diabetes is a combination of proper diet and a metformin pill regimen. As the disease progresses to insulin dependence, insulin injection therapy is the most common treatment. This therapy is lifelong and often very painful resulting in poor compliance. With such a large percentage of our population affected by this disease, it is hard to find any individual who has not been touched in some way by the progressively debilitating effects of diabetes. As a researcher and now a scientific advisor, I believe the potential of Generex Oral-lyn(TM) for the treatment of diabetes and the use of its proprietary drug delivery system has the potential to represent one of the most important advancements in the treatment of this disease in decades.
In 2009, Generex made significant advancements toward the commercialization of this drug delivery opportunity. The most significant of these advancements took place in September of 2009 when the United States Food and Drug Administration granted approval for the use of Generex Oral-lyn(TM) under the USFDA's Treatment Investigational New Drug program. Under the structured Treatment IND protocol, Generex Oral-lyn(TM) is available to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available, and who are not eligible to participate in the Company's on-going Phase III clinical trial. This approval will allow many patients in desperate need of insulin treatment alternatives to get the help they need and brings the Company one step closer to commercialization in the United States. Additionally, 2010 should be a watershed year for Generex as we have over 375 subjects enrolled in our on-going global Phase III clinical trial of Generex Oral-lyn(TM). We expect to complete this pivotal study in 2010 and the study results will form the nucleus of submissions to regulatory authorities for product approvals in the United States, Canada, Europe, and other jurisdictions. We at Generex are confident that the efficacy and safety data of this and previous studies will provide convincing evidence that Generex Oral-lyn(TM) is not only a viable alternative to current treatments, but may indeed become the preferred method of delivery for insulin treatment.
While I find this commercialization opportunity at Generex reason enough for one to be excited about what the future holds for this Company in 2010 and beyond, it might just be the tip of the iceberg for this truly dynamic Company. I will discuss my thoughts regarding what I believe is the true and vast untapped potential of the science at Generex in the third and last part of this series.
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 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.