SOURCE: Generex Biotechnology

November 22, 2005 09:00 ET

Generex Biotechnology Augments Regulatory Team With Engagement of Regulatory Affairs Consultant

TORONTO -- (MARKET WIRE) -- November 22, 2005 -- Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that it has augmented its regulatory team with the engagement of Dr. Judith Atkins, Ph.D. as a consultant. Dr. Atkins will assist the Company with (a) the completion and implementation of the Company's strategy for the next and final clinical and regulatory stages of Oral-lyn™, the Company's proprietary oral insulin spray product, in the United States and Canada with a view to expediting the process, (b) the development and implementation of the next stages of clinical and regulatory development of the Company's pain management program with a view to expediting regulatory approvals and the Company's access to the commercial market, and (c) the development and implementation of the next stages of clinical and regulatory development of the Antigen Express avian influenza vaccine program on an expedited basis in the United States and Canada.

Dr. Atkins holds a Ph.D. in biochemistry from the University of Ottawa, an M.Sc. in metabolism from the University of Alberta, and a B.Sc. in nutrition and metabolism from the University of Toronto. Dr. Atkins has held positions as the Director of Regulatory Affairs and Compliance for Amgen Canada Inc. and the Director of Regulatory Affairs, Research to Launch for Aventis Pasteur Limited.

"We are pleased to welcome Dr. Atkins to the Generex regulatory team. Her expertise and experience make her well-placed to help Generex quickly move forward with our product pipeline regulatory programs," said Anna Gluskin, the Company's President & Chief Executive Officer.

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™ device. The Company's flagship product, oral insulin (Oral-lyn™), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world. Antigen Express is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases.

For more information, visit the Generex website at or the Antigen Express website at

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.

Contact Information

  • Shayne Gilliatt
    Generex Biotechnology Corporation

    Ed Lewis
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    for Generex Biotechnology Corporation