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Generex Biotechnology Corporation (GNBT) Announces New Treatment IND Site for the US FDA Expanded Access Treatment IND Program for Generex Oral-lyn(TM) in the United States


2/23/2011 7:28:31 AM

WORCESTER, Mass., Feb. 23, 2011 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTC Bulletin Board: GNBT) announced today that Stamford Hospital has agreed to participate in the United States Food and Drug Administration (FDA) Expanded Access Treatment Investigational New Drug (IND) Program for Generex Oral-lyn, the Company's proprietary buccal insulin spray product for the treatment of patients with diabetes.

(Logo: http://photos.prnewswire.com/prnh/20110106/NY25057LOGO-b )

Stamford Hospital (www.stamfordhospital.org) is a not-for-profit provider of comprehensive healthcare services in Connecticut. The mission of Stamford Hospital is to provide, together with its physicians, a broad range of high quality health and wellness services focused on the needs of the communities it serves. Stamford Hospital is a member of the Planetree Alliance, a group of hospitals nationwide focused on patient-centered care. Stamford Hospital is affiliated with the New York Presbyterian Health System and is a major teaching affiliate of the Columbia University College of Physicians and Surgeons.

The successful opening of Stamford Hospital's Diabetes and Endocrine Center in 2008, housing its Endocrinology practices, first of Dr. Anna C. Freitag M.D., F.A.C.P., F.A.C.E., M.A.C.D.S., C-MC, Medical Director, and most recently of Dr. Bismruta Misra M.D., M.P.H., as well as an established Diabetes Education Program, was an organizational strategic initiative developed and supported by Stamford Hospital. The medical staff at the Diabetes and Endocrine Center provides exemplary care and treat a full range of diabetes and endocrine conditions and disorders. The Diabetes Self Management Education Program, established in 2002, provides quality diabetes educational services for people who have been diagnosed with diabetes. The education program has maintained its American Diabetes Association (ADA) education program recognition certificate through 2015, and currently all nursing and dietitian instructional team members are Certified Diabetes Educators.

Under the FDA's Expanded Access Treatment IND program, Generex Oral-lyn is available to patients with serious or life-threatening diabetes where no satisfactory alternative therapy is available. The program is open to patients who comply with the inclusion criteria of the treatment protocol (including those who are taking currently approved anti-diabetic medications). There are no oral or injectable medications contra-indicated for the program.

To learn more about the availability of Generex Oral-lyn under the Treatment IND program, as per FDA requirements, Generex has provided information on the www.ClinicalTrials.gov website. Details include program design and participating sites and/or physicians.

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 RapidMist device. The Company's buccal insulin spray product, Generex Oral-lyn is in Phase III clinical trials at several sites around the world. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutic vaccines for the treatment of malignant, infectious, allergic, and autoimmune diseases. Antigen Express has pioneered the use of specific CD4+ T helper stimulation in immunotherapy. One of its platform technologies relies on inhibition of expression of the Ii protein. Antigen Express scientists, and others, have shown clearly that suppression of expression of the Ii protein in cancer cells allows for potent stimulation of T helper cells and prevents the further growth of cancer cells. 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 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 or ultimate regulatory approval cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory agency. 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



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