12/11/2008 Generex Biotechnology Update On Novel Immunotherapeutic Vaccine to be Presented At San Antonio Breast Cancer Symposium
Thursday December 11, 2008, 10:03 am EST
WORCESTER, Mass., Dec. 11, 2008 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (NasdaqCM:GNBT - News) (http://www.generex.com) announced today that further results from its clinical trial of a novel immunotherapeutic cancer vaccine being developed by its wholly-owned subsidiary, Antigen Express, Inc., will be presented at the 31st annual San Antonio Breast Cancer Symposium (http://www.sabcs.org, December 11-14). The new findings will be presented by COL George Peoples, MD, a collaborator of Antigen Express who has been directing the trials at the Brooke Army Medical Center.
The new findings describe additional immunological results as well as longer-term responses in vaccinated breast cancer patients than were previously reported. In particular, increased specific immune responses persisted in patients for up to a year after the immunizations. Further, a specific cell type known to dampen the immune response (T regulatory cells) was shown to be reduced in nine of nine patients examined. Finally, there was good correlation between the reduction in T regulatory cells and a positive skin test (delayed type hypersensitivity reaction) in vaccinated patients. All of these findings bolster the initial clinical trial results showing that the new compound, AE37, is safe, well tolerated and produces the desired immunological response.
In addition to being the subject of a Phase II efficacy trial in breast cancer patients, AE37 is also being tested in a Phase I trial in patients with prostate cancer. Those studies, being conducted by Drs. Costas Baxevanis and Aristides Karagiannis, have finished enrollment and are expected to be completed by early 2009.
The San Antonio Breast Cancer Symposium (SABCS) is a division of the Cancer Therapy & Research Center (CTRC). CTRC is an independent, non-profit institution committed to providing the highest quality cancer treatment, research, and education. The objective of the SABCS is to provide state-of-the-art information on the experimental biology, etiology, prevention, diagnosis, and therapy of breast cancer and premalignant breast disease to an international audience of academic and private physicians and researchers. The scientific program consists of invited lectures and mini-symposia by experts in clinical and basic research, selected slide and poster presentations, and case discussions. This international symposium is directed primarily towards academic and private physicians and researchers involved in breast cancer in medical, surgical, gynecologic, and radiation oncology, as well as other appropriate health care professionals.
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 flagship product, oral insulin (Generex Oral-lyn), which is available for sale in India 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. Antigen Express, Inc. 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 http://www.generex.com or the Antigen Express website at http://www.antigenexpress.com.
The Generex Biotechnology Corp. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3831
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.
Contact:
CEOcast, Inc.
Gary Nash
212-732-4300
American Capital Ventures, Inc.
Howard Gostfrand
1-877-918-0774
Shayne Gilliatt of Generex Biotechnology Corporation, 1-800-391-6755, or
+1-416-364-2551; or Ken Sgro of CEOcast, Inc., 212-732-4300,
kensgro@ceocast.com, for Generex Biotechnology Corporation
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