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Generex Biotechnology Makes Poster Presentations of Clinical Data at Endo 2006

Posted on: Tuesday, 27 June 2006, 09:00 CDT

Generex Biotechnology Corporation (NASDAQ: GNBT), a leader in the area of buccal drug delivery, announced today that it made two poster presentations of clinical data that The Endocrine Society's 88th Annual Meeting (www.endo-society.org) in Boston, June 24 - 27, 2006.

The first poster, entitled The Generex Metformin Gum: An Alternative Method for Delivery of Biguanides, was authored by Drs. Jaime Guevara-Aguirre, David Saldarreaga, Marco Guevara-Aguirre, and Jeannette Saavedra of the Institute of Endocrinology IEMYR in Quito, Ecuador, and Dr. Gerald Bernstein, the Company's Vice-President - Medical Affairs.

The poster reports the results of a clinical trial designed to compare pharmacokinetic profiles of metformin (used for the treatment of Type-2 diabetes mellitus in adults and children) administered by both the traditional manner (tablets) and by an alternative presentation (the Generex Metformin Gum product) that can be chewed thereby delivering metformin into the human body by way of the buccal cavity (i.e., the mouth).

The conclusion of the study is that the Generex Metformin Gum displays a pharmacokinetic profile similar to that of the metformin tablets and therefore shows promise as an alternative method of delivering metformin. The Generex Metformin Gum presentation should avoid the significant adverse gastrointestinal side-effects often accompanying the use of metformin tablets thereby improving patient compliance. In addition, Generex Metformin Gum is expected to be an ideal companion product for the Company's oral insulin spray product, Generex Oral-lyn(TM). Generex Oral-lyn is designed to offer a safe, simple, fast, effective, flexible, and familiar alternative to subcutaneous injections of prandial insulin.

The second poster, entitled Transfer From Short-Acting Insulin to Generex Oral-lyn(TM) at Lunchtime in 27 Juvenile Type-1 Diabetes Mellitus Patients: Importance of Diabetes Monitoring During the Stabilization Phase of a 6-Month Study, was authored by Drs. Jaime Guevara-Aguirre, Marco Guevara-Aguirre, and Jeannette Saavedra of the Institute of Endocrinology IEMYR in Quito, Ecuador, and Dr. Gerald Bernstein, the Company's Vice-President - Medical Affairs.

The poster reports observations during the initial phase of an on-going long-term study, taking place at the Institute of Endocrinology IEMYR in Quito, Ecuador with Dr. Guevara as principal investigator, performed in 24 adolescent and 5 young adult patients with Type-1 diabetes mellitus receiving subcutaneously (s.c.) injected twice daily (BID) glargine insulin as basal therapy and s.c. regular insulin before meals. The principal aim of the study is to compare the effects of replacing the lunchtime dose of s.c. regular insulin with Generex Oral-lyn given as a split dose before and after lunch.

Since the study participants were referred to the institute in various degrees of metabolic control, it was necessary to stabilize them using standard therapy before replacement of the s.c. injection by Generex Oral-lyn at lunchtime. For this purpose, in addition to s.c. BID basal therapy and pre-prandial s.c. insulin, participants received enhanced nutritional advice and intense glucose monitoring for 21 days prior to replacement of the s.c. injected insulin by Generex Oral-lyn. The poster reports that the participants were metabolically stabilized in 21 days as documented by improvements in 6-point glucose daily profiles and protein glycation parameters that, in addition, showed correlation.

"We are pleased that the international scientific community has recognized the significance of this work," said Anna Gluskin, Generex President & Chief Executive Officer. "We are honored to present these study designs, methodologies, results, and conclusions to the ENDO 2006 participants."

The Endocrine Society is the world's largest and most active professional organization of endocrinologists in the world. Founded in 1916, the Society is internationally known as the leading source of state-of-the-art research and clinical advancements in endocrinology and metabolism. The Endocrine Society is dedicated to promoting excellence in research, education and clinical practice in the field of endocrinology.

The Endocrine Society is an international body with 13,000 members from over 85 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.

The Endocrine Society 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

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 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.

 Contact: Shayne Gilliatt Generex Biotechnology Corporation Phone: (800) 391-6755 (416) 364-2551 Andrew Hellman CEOcast, Inc. Phone: (212) 732-4300  

SOURCE: Generex Biotechnology

Source: MARKET WIRE

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