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Generex Oncology Receives New Patent for AE37 Immunotherapeutic Cancer Vaccine
Thursday, February 03, 2011
Worcester, MA -- Generex Biotechnology Corporation (www.generex.com) (OTC Bulletin Board: GNBT), together with its wholly-owned immunotherapeutic vaccines subsidiary, Antigen Express, Inc. (www.antigenexpress.com), announced today that Antigen Express has received a Notice of Allowance from the United States Patent Office relating to an application making augmentative pharmaceutical composition claims for the Antigen Express AE37 immunotherapeutic cancer vaccine. The Company has previously received allowances of broad claims surrounding its Ii-Key hybrid technology, which was used in the design of the AE37 vaccine platform. The current allowance strengthens independent composition of matter claims directed to the AE37 peptide. The full term of the new patent will extend through January 5, 2028.
AE37 is currently the subject of a randomized and controlled Phase II efficacy study in patients treated for breast cancer who are at high risk of recurrence. Favorable results from this study have been reported previously. This immunotherapeutic vaccine also has been tested in a Phase I study in patients with prostate cancer, which confirmed the safety and immunogenicity observed in the prior breast cancer study. In addition to breast and prostate cancer, many other types of cancer, such as lung, colon, stomach and bladder, also express the HER2 protein, which is the target for an AE37 stimulated immune response.
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. The Company's buccal insulin spray product, Generex Oral-lyn™ is in Phase III clinical trials at several sites around the world. 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 www.generex.com or the Antigen Express website at www.antigenexpress.com.
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 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.
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