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Generex Biotechnology Awarded Patent in Japan For Its Antigen Presentation Technology
Tuesday, December 18, 2007
Worcester, MA -- Generex Biotechnology Corporation (Nasdaq: GNBT) announced today that its wholly owned subsidiary, Antigen Express, Inc., has been awarded a Japanese patent strengthening its proprietary antigen presentation technology platform. The patent, entitled "Regulation of Antigen Presentation", strengthens specific aspects the Antigen Express peptide vaccine and immunomodulation technology.
The technology protected under the patent relates to specific methods for enhancing antigen-specific T helper cell stimulation using small synthetic peptides. Both prophylactic and immunotherapeutic vaccine peptides are currently under development at Antigen Express. The most advanced of these is an immunotherapeutic vaccine that has entered Phase II clinical trials in breast cancer patients and a Phase I trial in patients with prostate cancer. Other vaccine peptides, designed using the same technology, are being tested in a Phase I clinical trial for their ability to generate an immune response against the potentially pandemic H5N1 avian influenza virus.
The importance of antigen-specific T helper stimulation in controlling the immune response has been demonstrated in many areas of immunology ranging from protection against infectious diseases to oncology to autoimmunity. Consequently, specific means for controlling T helper cell stimulation offers the possibility of a wide range of therapeutics. Antigen Express has aggressively pursued development and intellectual property coverage of its technology platforms as well product development.
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. The Company's flagship product, oral insulin (Generex Oral-lyn), which is available for sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes and which was approved for sale in India in October 2007, is in various stages of clinical development around the world. In June 2007 the Company announced that patient dosing in a global Phase III clinical trial of Generex Oral-lyn will commence before year end. For more information, visit the Generex website at www.generex.com.
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 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.
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