GNBT,
Generex Biotechnology Announces Additional Preliminary Results in a Trial of Generex Oral-lyn(TM) in Adolescent / Young Adult Patients With Type-1 Diabetes
Wednesday March 15, 8:30 am ET
TORONTO--(MARKET WIRE)--Mar 15, 2006 -- Generex Biotechnology Corporation (NasdaqSC:GNBT - News), a leader in the area of buccal drug delivery, announced today additional preliminary results (10 weeks) of a long-term (six month) clinical trial of Generex Oral-lyn, the Company's proprietary oral insulin spray product, in adolescent and young adult patients with Type-1 diabetes mellitus. This data, which complements the positive data announced by the Company on March 8, 2006, shows the variations of glycosylated hemoglobin (HbA1c), a very well-known marker for monitoring diabetes, during the first 10 weeks of the study.
Source: Generex Biotechnology
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Glycosylated hemoglobin (HbA1c) is considered by regulatory agencies and endocrinologists as the best long-term measure of metabolic control of diabetes. "HbA1c correlates with the level of risk for diabetes complications," said Dr. Gerald Bernstein, the Company's Vice-President for Medical Affairs. "The continuous and dramatic reduction seen in these preliminary results bode well for patients with diabetes, and society generally, in reducing the burdens of diabetes and its complications."
The investigators concluded that, during the first 10 weeks of this ongoing six-month trial, replacement of subcutaneous injections of regular insulin by Generex Oral-lyn at lunchtime in adolescent and young adult patients with Type-1 diabetes was associated with overall adequate glycemic control and similar glycosylated hemoglobin (HbA1c) concentrations.
About Generex
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 (Oral-lyn(TM)), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world.
For more information, visit the Generex Web site at www.generex.com.
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.
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Contact:
Contact:
Shayne Gilliatt
Generex Biotechnology Corporation
Phone: (800) 391-6755 and (416) 364-2551
Ed Lewis
CEOcast, Inc.
Phone: 1 (212) 732-4300
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Source: Generex Biotechnology
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