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Generex Provides Update on Generex Oral-lyn™ Clinical & Regulatory Program

WORCESTER, Mass. and TORONTO, Dec. 1, 2011 /PRNewswire/ -- Generex Biotechnology Corporation ( (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 expeditious regulatory review and marketing clearance.

The Company also announced today that the next investor conference call, initially scheduled for late November, will be rescheduled to early January, 2012.  "The Generex management team and its advisors have been working diligently on the previously announced strategic development plan, including the spinout of Antigen Express, the Generex reverse stock split, the stock dividends of Antigen stock to the Generex stockholders, and the clinical and regulatory development programs for Generex Oral-lyn™ and the the AE37 immuno-therapuetic vaccines platform technologies, and significant progress has been made," said Mark Fletcher, the Generex President & Chief Executive Officer.  "In order that the investor conference call will be as productive, informative, and useful as possible, we have elected to reschedule the call to a later date when the plan will have achieved greater maturity and specificity so as to be in a position to provide a more comprehensive and detailed report to our stockholders."

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.  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 or the Antigen Express website at

Cautionary Note Regarding Forward-Looking Statements

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," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" 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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