Generex Biotechnology Announces Publication of Oral-lyn(TM) Research Study by Hadassah Hebrew University Hospital Research Team, Jerusalem, Israel

Company's oral insulin formulation has faster onset and shorter duration of action than regular injected insulin and is absorbed in direct relation to the amount given

TORONTO, June 7 -- Generex Biotechnology Corporation (Nasdaq: GNBT), a leader in the area of buccal drug delivery, today announced that well-known diabetes investigators Professor Itamar Raz, Dr. Simona Cernea, Dr. Miriam Kidron and Dr. Jay Wohlgelernter, all of the Diabetes Unit, Department of Internal Medicine, Hadassah Hebrew University Hospital, Jerusalem, Israel, have published an Oral-lyn(TM) research paper in the June, 2005 issue of Diabetes Care (Volume 28, Number 6:1353-1357), an international peer-reviewed journal published by the American Diabetes Association (Copyright (C) 2005).

The paper is entitled Dose-Response Relationship of Oral Insulin Spray in Healthy Subjects. The purpose of the study was to evaluate the pharmacodynamic and pharmacokinetic properties and the dose-ranging effects of Oral-lyn(TM) in comparison with subcutaneous regular insulin.

Oral-lyn(TM) is Generex's propriety oral insulin spray formulation which is delivered into, and absorbed by, the buccal mucosa in the mouth (with no lung deposition) via the Company's proprietary RapidMist(TM) device.

In the randomized, five-way, cross-over study, seven healthy volunteers were assessed under euglycemic clamp and received four different doses of Oral-lyn(TM) and one dose of subcutaneous regular insulin. The study demonstrated that the time to maximum insulin concentration was shorter for Oral-lyn(TM) than for subcutaneous insulin. Maximum serum insulin levels were comparable between the subcutaneous and 20 puffs of Oral-lyn(TM). The area under the insulin curve (Ins-AUC0-120) and maximum serum insulin levels (Cmax) proved a dose-response relationship for the three doses of Oral-lyn(TM) (5, 10, and 20 puffs). Oral-lyn(TM) had an earlier onset of action and a shorter duration of action compared with subcutaneous insulin. The maximum metabolic effect and the amount of glucose infused from 0 to 120 minutes (GIR-AUC0-120) increased in a dose-dependent relationship for the three doses.

The study concluded that Oral-lyn(TM) is absorbed in direct relation to the amount given and had a faster onset and a shorter duration of action compared with subcutaneous regular insulin. Also, a dose-response relationship was noted in the absorption and metabolic effect of Oral-lyn(TM). Diabetes Care, published by the American Diabetes Association, is a journal for the health care practitioner that is intended to increase knowledge, stimulate research, and promote better management of people with diabetes. To achieve those goals, the journal publishes original articles on human studies in the following four categories: 1) clinical care/education/nutrition, 2) epidemiology/health services/psychosocial research, 3) emerging treatments and technologies, and 4) pathophysiology/complications. The journal also publishes clinically relevant review articles, letters to the editor, and health/medical news or points of view. Topics covered are of interest to clinically oriented physicians, researchers, epidemiologists, psychologists, diabetes educators, and other health professionals.

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)), is in various stages of clinical trials around the world. For more information, visit the Generex Web site at http://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 claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Source: Generex Biotechnology Corporation, http://www.generex.com PRNewswire-FirstCall