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Generex Biotechnology Announces Results of a Trial Using Generex Oral-lyn(TM) in Adolescent and Young Adult Patients With Type-1 Diabetes Mellitus


2006-04-10 09:00 ET - News Release

TORONTO -- (MARKET WIRE) -- 04/10/06

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Generex Biotechnology Corporation (NASDAQ: GNBT), a leader in the area of buccal drug delivery and developer of Generex Oral-lyn™, the Company's proprietary oral insulin spray product, announced today interim three-month results of a long-term six-month clinical trial performed in 24 adolescents and 5 young adult patients with Type-1 diabetes mellitus (DM). This data continuously showed that replacing just 1 one daily subcutaneous injection (s.c.) of regular insulin with Generex Oral-lyn™ during the day, improves parameters of metabolic control in the same manner observed with intensively monitored standard therapy.

At the 3rd month evaluation of this six-month trial, it was demonstrated that a trend similar towards normalization exists when replacing the lunch-time dose of regular insulin with the Generex Oral-lyn™ spray. In fact, not only Daily Glucose Profiles and Fructosamine demonstrated improved values but, of special importance, Glycosylated Hemoglobin (HbA1c), the criterion standard to evaluate metabolic control in Diabetes, showed a significant improvement when compared to standard therapy. The investigators concluded, in their three-month interim analysis, that successful and efficient replacement of injected regular insulin at lunchtime was achieved with Generex Oral-lyn™ altogether with 100% compliance.

These encouraging results prompted the investigators and the partners Generex-Pharmabrand to design studies using larger number of Type-1 DM subjects and replacing the three mealtime doses of regular insulin with the Generex-Oral-lyn™ spray on subjects maintained in once daily glargine insulin therapy. These larger studies will be designed for approval in Canada and other countries.

Marketing Program sponsored by the Consortium Generex-Pharmabrand.-

The above mentioned data was presented and discussed in a seminar that included a marketing program. It was held by the Company's Joint Venture partner, PharmaBrand SA. All three-month results in safety and efficacy were discussed in Quito, Ecuador by Dr. Jaime Guevara-Aguirre M.D. during a meeting of 150 doctors (Pharmabrand sponsored this meeting as part of its post-approval marketing program). The results were received with enthusiasm by the doctors who will make use of them when Generex Oral-lyn™ is marketed and distributed nationwide in the next few weeks.

A week-long training seminar concluded Thursday, April 6, 2006, for the PharmaBrand S.A. sales force, which is preparing to begin nationwide marketing of the first commercial run of Generex Oral-lyn™ produced in Ecuador.

The April 2006 issue of Pediatrics features a study on the prevalence and correlation of depressed mood in adolescents with diabetes, entitled, "Prevalence and Correlates of Depressed Mood Among Youth with Diabetes." The results of the study showed an association between higher mean HbA1c and frequency in emergency room visits, and depressed mood. "The Pediatrics study demonstrates the vicious cycle created by a breakdown of therapy, increased complications leading to depressed moods in adolescents. Dr. Guevara-Aguirre's results shows that patient friendly Generex Oral-lyn™ leads to continuous compliance in adolescents," said Anna Gluskin, Generex's President & Chief Executive Officer.

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. Antigen Express 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.

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: [phone]
and [phone]

Ed Lewis
CEOcast, Inc.
Phone: [phone]