WORCESTER, Mass., July 22, 2009 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that the Company held a meeting with the Veterinary Drugs Directorate (VDD) of Health Canada on July 14th in Ottawa, Canada. The meeting was a Pre-New Drug Submission (NDS) meeting for the purpose of outlining the Company's proposed development plan for the veterinary application of Generex Oral-lyn, the Company's proprietary oral insulin spray product, with a view to proceeding with the filing of an NDS. As a result of this meeting, the Company plans to prepare an IND package for submission to the VDD before the end of this year.
Anna Gluskin, the Company's President & Chief Executive Officer, commented: "We are delighted to have made the necessary progress to further establish our plans for our flagship product, Generex Oral-lyn(tm), in the veterinary field. This step is very important in that it paves the way for improved treatment for companion dogs (and later cats) suffering from diabetes. Generex Oral-lyn(tm) will provide a more user-friendly option to pet owners and encourage compliance."
To date, the company has conducted a two-year safety study on dogs as well as drafted a preliminary clinical design in order to meet some of the regulatory requirements for the IND application.
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(tm) device. The Company's flagship product, oral insulin (Generex Oral-lyn(tm)), which is available for sale in India, Lebanon, Algeria, and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. For more information, visit the Generex website at http://www.generex.com.
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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 cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.