Generex Biotechnology Phase I Trial Results for Novel Immunotherapy Vaccine in Breast Cancer Patients Presented At ASCO
Results Conclude Vaccine is Safe and Well-Tolerated in Patients
To be Published in July Issue of The Journal of Clinical Oncology
WORCESTER, Mass., June 3, 2008 -- Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com) presented final results of the Phase I trial of the Company's novel AE37 immunotherapeutic vaccine in breast cancer patients at the 44th annual meeting of the American Society of Clinical Oncology (ASCO, www.asco.org) in Chicago, Illinois held May 30 through June 3. AE37, a therapeutic vaccine, is being developed by the Company's wholly owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com), for a number of indications in oncology. The Phase I trial concluded the vaccine was safe and well tolerated in breast cancer patients.
The vaccine is derived from a fragment of the HER-2/neu oncogene, which is over-expressed in a variety of tumors, including breast, ovarian, prostate, colon and lung tumors. The Phase I breast cancer trial was conducted by Dr. George Peoples at the Walter Reed Army Medical Center.
The completed Phase I trial was a dose escalation study to establish the safety and immunologic activity of AE37 in 15 node-negative breast cancer patients. The patients received 6 immunizations at monthly intervals of 100, 500 or 1000 mcg. AE37 combined with 0 to 250 mcg. GM-CSF as adjuvant. Because of a robust local response in patients receiving 500 mcg. AE37, patients were dosed with 1000 mcg. AE37 in the absence of adjuvant. Even in the absence of adjuvant, two of the three patients receiving 1000 mcg. AE37 required a reduction in the amount of AE37 because of a robust local response, indicating the inherent potency of AE37. Analysis of T cells taken from patients as well as delayed-type hypersensitivity tests demonstrated that there was a significant and specific immune response in patients receiving AE37. A full report, entitled "Results of the First Phase I Clinical Trial of the Novel Ii-Key Hybrid Preventive HER-2/neu Peptide (AE37) Vaccine," has been accepted for publication and will appear in the July issue of the Journal of Clinical Oncology.
"The completion of the Phase I breast cancer trial for AE37 is a significant milestone and accomplishment for Generex," commented Anna Gluskin, President and Chief Executive Officer of Generex. "The results of this trial offer proof of our progress in successfully bringing AE37 through the clinical regulatory process. This trial represents the first human experience with the Ii-Key modification, and to our knowledge AE37 is the first peptide-based cancer vaccine to show potency in the absence of an immunoadjuvant. We look forward to the progression of our Phase II trial of AE37, currently underway, as well as the possible expansion of our AE37 immunotherapy trials."
The AE37 vaccine is based on one of two proprietary platform technologies established at Antigen Express. The technology entails the modification of fragments of antigens to increase their potency in stimulating CD4+ T helper cells, resulting in a more robust specific response to the antigen as well as immunological memory. Currently, AE37 is the subject of a Phase II trial to establish efficacy by preventing recurrence in node-positive and high-risk node-negative breast cancer patients, being conducted by Dr. George Peoples at the Brooke Army Medical Center, and a Phase I trial in prostate cancer patients, being conducted by Dr. Aristides Karagiannis and Dr. Costas Baxevanis at the Euroclinic in Athens, Greece. In addition to the oncology trials, Ii-Key modified peptides derived from the H5N1 avian influenza virus are also the subject of a Phase I investigation.
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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