Generex Biotechnology Phase I Trial Results for Novel ImmunotherapyVaccine 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, MA, June 3, 2008 (PRIME NEWSWIRE) --Generex Biotechnology Corporation 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 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., 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 µg AE37 combined with 0 to 250 µg GM-CSF as adjuvant. Because of a robust local response in patients receiving 500 µg AE37, patients were dosed with 1000 µg AE37 in the absence of adjuvant. Even in the absence of adjuvant, two of the three patients receiving 1000 µg 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™ 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 Phase 3 clinical trials at several sites around the world.
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.
Posted: June 2008