WORCESTER, Mass. -- Generex Biotechnology Corporation (www.generex.com) (GNBT.OB) 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(TM), the Company's proprietary buccal insulin spray product for the treatment of patients with diabetes.

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(TM) 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(TM) 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.

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