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Generex Biotechnology Comments on New ADA/EASD Consensus Algorithm for Type 2 Diabetes Treatment


Company Believes Generex Oral-lyn May Play Valuable Role in Treatment Paradigm

WORCESTER, MA., Oct. 30, 2008 (GlobeNewswire) -- Generex Biotechnology Corporation (NasdaqCM:GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today commented on the consensus algorithm for Type 2 diabetes treatment issued by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) published online on October 22, 2008 (Diabetes Care, volume 31, number 12, December 2008).

A joint panel of ADA and EASD experts updated the treatment recommendations for Type 2 diabetes in a consensus statement which provides guidance to health care providers. The algorithm describes a stepped-care approach to treat the elevated blood glucose levels that characterize diabetes. The first step is comprised of lifestyle modifications and metformin. If glucose/glycemic parameters are not met or maintained, the algorithm proceeds to the second step which provides for either (a) the addition of basal insulin or sulfonylurea, or (b) the addition of pioglitazone or a GLP-1 agonist. The algorithm states that (a) is the preferred and well-validated approach. If the second step paradigm does not meet or maintain glucose/glycemic goals, the third step is a transition to intensive insulin therapy.

In a joint ADA/EASD press release, Dr. David M. Nathan, Chair of the Panel, stated: "Excellent glycemic control is critical to prevent the long-term complications associated with diabetes, which can lead to loss of vision, kidney failure, and amputations."

Generex believes that Generex Oral-lyn, the Company's proprietary oral insulin spray product which delivers insulin into the mouth using the Company's proprietary RapidMistT drug delivery device (with no pulmonary deposition), can play a valuable role in the ADA/EASD consensus algorithm.

As noted by the algorithm, early and aggressive use of insulin therapy as the second step of treatment is preferred. Early insulin treatment can offer a more rapid restoration of normal blood glucose levels and assist in beta cell preservation (beta cells produce insulin). Insulin, as a natural hormone produced by the body, is less likely to result in side effects.

However, patients and physicians tend to resist the application of insulin therapy because it is delivered by injection. The Company believes that Generex Oral-lyn, as a safe, convenient, simple, fast, effective, familiar and pain-free alternative to prandial insulin injections, can augment the early intervention insulin therapy for Type 2 diabetes contemplated by the algorithm and assist in delaying the progression of the disease and the onset of its myriad complications.

Generex Oral-lyn is human regular insulin in a liquid formulation with small amounts of GRAS excipients delivered into the oral cavity with the RapidMist drug delivery system utilizing an asthma-like spray. Unlike inhaled insulin products, the micelles that are released into the mouth are greater than seven microns and cannot enter the lungs. This system allows Generex Oral-lyn to penetrate the epithelial lining of the mouth and enter the rich vascular bed beneath. This assures rapid appearance in the blood stream, peaking at two hours, and because there is no tail of activity as with all other insulins, the hypoglycemic risk is minimized. Blood levels return to baseline at two hours. This affords great flexibility in usage. The simplicity of the system, especially the familiarity of the asthma-like device to patients and physician, makes it readily acceptable to patients and physicians. Generex Oral-lyn is delivered as a metered dose. Essentially, one puff equals one unit of insulin delivered to the blood stream. Generex Oral-lyn has proven to be safe and has been administered to more than a thousand patients, some for more than a year.

Generex Oral-lyn is presently in the midst of global Phase 3 clinical trials. To date, 260 subjects have been enrolled in the trials at 69 sites in seven countries.

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 and approved for sale in India for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. For more information, visit the Generex website at

Safe Harbor Statement

This release and oral statements made from time to time by Generex representatives in respect of 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.

Posted: October 2008