WORCESTER, Mass., July 9, 2008 (PRIME NEWSWIRE) -- An Investigational New Drug application (IND) has been submitted to the United States Food and Drug Administration (FDA) on behalf of Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com) for its AE37 immunotherapeutic vaccine combined with a vaccine peptide that works by a different mechanism for patients. The immunotherapeutic cancer vaccine AE37 is being developed through Antigen Express, Inc. (www.antigenexpress.com), the wholly owned immunotherapeutics subsidiary of Generex.
Currently, AE37 is the subject of a Phase II study in patients with breast cancer under an IND by Dr. George Peoples at the Brooke Army Medical Center as well as a Phase I study in prostate cancer patients conducted by Drs. Aristides Karagiannis and Costas Baxevanis at the Euroclinic in Athens, Greece. The additional Phase I clinical trial in breast and ovarian cancer will be funded by Mary Crowley Medical Research Centers.
The new Phase I clinical trial will examine the safety and immunological response of breast and ovarian cancer patients to a combination of AE37 plus a peptide vaccine designed to stimulate cytotoxic T lymphocytes (CTL). The results of previous early stage clinical trials of CTL-specific peptide vaccines have suggested their potential for therapeutic efficacy; however, the immunity stimulated by CTL vaccines has been short-lived.
"The modified immunotherapeutic vaccine AE37 represents a 'second generation' peptide vaccine with clear advantages over the initial T helper vaccine peptides tried in the clinic," commented Dr. Peoples. "It makes perfect sense to combine this novel immunotherapeutic vaccine with a killer T cell-specific vaccine."
AE37 is a novel peptide vaccine that is the product of a proprietary technology platform established at Antigen Express designed to increase the antigen-specific stimulation of CD4+ T helper cells. Antigen-specific stimulation of this cell type is crucial if the immune system is to recognize a novel pathogenic agent and to mount a robust and lasting response against it. T helper stimulation is particularly important in developing effective immunotherapy against cancer.
"The Antigen Express vaccine technology represents a significant advance in the development of immunotherapeutic vaccines for cancer," added Dr. John Nemunaitis, Director of Mary Crowley Research Center (Mary Crowley). "We are excited to commence this trial between Mary Crowley, Dr. George Peoples, and Antigen Express."
"We are very grateful to Mary Crowley for their recognition of the potential of the Antigen Express technology and for funding this latest clinical trial," said Anna Gluskin, President & Chief Executive Officer of Generex. "We look forward to a productive and successful trial as well as future collaborations with Mary Crowley."
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 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 Phase 3 clinical trials at several sites around the world. For more information, visit the Generex website at www.generex.com.
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