Generex Biotechnology Presented Data at The Endocrine Society's Annual Meeting
Study Demonstrates Value of Human Insulin Therapy
WORCESTER, MA, June 19, 2008 (PRIME NEWSWIRE) -- Generex Biotechnology Corporation (NasdaqCM:GNBT, www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, made a podium presentation of data from a company-sponsored study at The Endocrine Society's 90th Annual Meeting (ENDO, www.endo-society.org <http://www.endo-society.org/> ) in San Francisco on June 18, 2008.
Doctor Jaime Guevara-Aguirre of the Institute of Endocrinology IEMYR, Quito, Ecuador, made a podium presentation of an abstract entitled, "Human Insulin Therapy is Safe, Efficacious, and Less Costly Than Insulin Analogs in the Treatment of Type-1 Diabetes." The abstract was co-authored by Doctor Jaime Guevara-Aguirre and Doctor Marco Guevara-Aguirre, both of the Institute of Endocrinology IEMYR; Professor Arlan L. Rosenbloom of the University of Florida; and Dr. Gerald Bernstein, the company's Vice-President for Medical Affairs.
The one-year study compared the efficacy and safety of analog versus human insulins. The study showed that human insulin administered as basal injection and with meals as orally absorbed regular insulin (Generex Oral-lynT, the company's proprietary oral insulin spray product) attained lower pre-meal glucose, HbA1c, and fructosamine concentrations when compared with a regimen using basal and pre-prandial insulin analogs in Type-1 diabetes. The cost of insulin analogs, basal and pre-prandial, is greater than that of recombinant human insulin, but this greater expense has been considered justified by therapeutic advantages. The study concluded that human insulin, when delivered through the buccal mucosa, is not inferior to analogues in the long-term treatment of Type-1 diabetes and could be used as a less costly alternative.
The company also made a poster presentation of an abstract entitled, "Serum Fructosamine Measurement is Adequate for Monitoring Long-Term Metabolic Control in Type-1 Diabetes." The abstract was co-authored by Doctors Jaime Guevara-Aguirre, Marco Guevara-Aguirre, and Jeannette Saavedra, all of the Institute of Endocrinology IEMYR, Quito, Ecuador; Edward Vidgen of the University of Toronto; Professor Arlan L. Rosenbloom of the University of Florida; and Dr. Gerald Bernstein, the company's Vice-President for Medical Affairs.
About The Endocrine Society
ENDO's mission is to advance excellence in endocrinology and promote its essential role as an integrative force in scientific research and medical practice. ENDO is an international body with thirteen thousand members from over eighty-five countries. The diverse membership represents medicine, molecular and cellular biology, biochemistry, physiology, genetics, immunology, education, industry, and allied health. Society members represent the full range of disciplines associated with endocrinologists: clinicians, researchers, educators, fellows and students, industry professionals, and health professionals who are involved in the field of endocrinology. These professionals are dedicated to the research and treatment of the full range of endocrine disorders: diabetes, reproduction, infertility, osteoporosis, thyroid disease, obesity/lipids, growth hormone, pituitary tumors, and adrenal insufficiency. ENDO works to foster a greater understanding of endocrinology amongst the general public and practitioners of complementary medical disciplines and to promote the interests of all endocrinologists at the national scientific research and health policy levels of government.
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 RapidMistT device. The Company's flagship product, oral insulin (Generex Oral-lynT), which is available for sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes and which was approved for sale in India in October 2007, is in Phase 3 clinical trials at several sites around the world.
Safe Harbor Statement
This release and oral statements made from time to time by Generex representatives concerning 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.
American Capital Ventures, Inc. For Generex: Howard Gostfrand 305-918-7000 CEOcast, Inc. Andrew Hellman 212-732-4300
Posted: June 2008