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Generex Provides Update on Generex Oral-lyn™ Clinical & Regulatory Program
Date:12/1/2011

WORCESTER, Mass. and TORONTO, Dec. 1, 2011 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB:GNBT) today provided an update on the status of the clinical and regulatory program for Generex Oral-lyn™, the Company's proprietary buccal insulin spray product.

Work has been completed on reviewing, validating, re-analyzing (including additional new analyses), and revising all of the extant Generex Oral-lyn™ Clinical Study Reports.  In addition, the data collection, analysis, review, and preparation of the final Clinical Study Report for the recently concluded Generex Oral-lyn™ Study 084, A 26-Week, Open-Label, Randomized, Active Comparator Study of Generex Oral-lyn™ Spray and Injected Human Insulin In Subjects With Type 1 Diabetes Mellitus, has been completed.

This will allow an on-schedule completion this quarter of Generex's response to USFDA queries (as described during the annual meeting of stockholders in June).  The new Generex Oral-lyn™ Investigators' Brochure (required for review and conduct of future Generex Oral-lyn™ studies) remains on schedule for completion, submission to the regulatory agencies of all countries participating in Generex Oral-lyn™ trials, and publication for investigators and ethical review boards in the first quarter of 2012.

The new clinical development plan, including pharmacokinetic and gluco-dynamic studies, a comprehensive clinical phase 3 program (to assure appropriate marketing approval to treat every type of patient with diabetes), and a small number of well-designed physiologic studies to demonstrate the unique advantages of Generex Oral-lyn™ (vital for marketing and reimbursement) will be announced early in the first quarter of 2012.  Additionally, a meeting with the USFDA will be scheduled in the first quarter to insure consensus with the clinical plan to help achieve an e
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