Generex Biotechnology Announces Publication of Generex Oral-LynStudy Results in Diabetes Technology & Therapeutics
WORCESTER, Mass., Aug 14, 2007 (PrimeNewswire via COMTEX News
Network) -- Generex Biotechnology Corporation (Nasdaq:GNBT), the
leader in drug delivery for metabolic diseases through the inner
lining of the mouth, announced today that the results of a Generex
Oral-lyn(tm) study have been published in Diabetes Technology &
Diabetes Technology & Therapeutics is a peer-reviewed journal covering new technology and new products for the treatment, monitoring, diagnosis, and prevention of diabetes and its complications.
The title of the published abstract is "Comparison of Oral Insulin Spray and Subcutaneous Regular Insulin at Mealtime in Type 1 Diabetes," authored by Jaime Guevara-Aguirre, M.D., Marco Guevara-Aguirre, M.D., Jeannette Saavedra, M.D., Gerald Bernstein M.D., and Arlan L. Rosenbloom, M.D.
The published conclusion is that regular insulin and Generex Oral-lyn had similar glucodynamic effects in subjects with Type-1 Diabetes Mellitus receiving twice-daily insulin analogue as baseline therapy. Intensive monitoring and timely corrections with additional snacks, additional sc regular insulin, or Generex Oral-lyn(tm) puffs resulted in appropriate glycemic control as assessed by individual daily glycemic responses and especially, normal preprandial glycation decreased, but not significantly.
"This publication is significant in that it shows consistently and clearly that equivalent amounts of Generex Oral-lyn and injected regular insulin will yield comparable blood glucose control," said Dr. Gerald Bernstein, Generex's Vice President of Medical Affairs and a co-author of the article.
Generex is engaged in the research and development 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 Ecuador for the treatment of patients with Type-1 and Type-2 diabetes and before the end of 2007 the Company expects to begin Phase 3 trials of the product in the United States, Canada and Europe.
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 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.
Posted: August 2007