Generex Biotechnology Corporation Announces Presentations Correlating Immunological Response With Reduced Recurrence In Phase 2 Study Of AE37 Breast Cancer Vaccine In Patients At The American College of Surgeons
WORCESTER, Mass. and TORONTO, Oct. 27, 2014 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) today announced two presentations demonstrating that the extent of the immunological response triggered by its novel proprietary cancer immunotherapeutic AE37 vaccine correlated with a reduction of relapse in breast cancer patients. The AE37 cancer vaccine is being developed by the Company's wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com). The presentations are being made at the American College of Surgeons Clinical Congress 2014, being held October 2630, 2014 in San Francisco, CA.
The AE37 cancer vaccine is designed to elicit a specific immunological response targeting the HER2 cancer-associated protein. The Company previously reported a strong trend toward reduced relapse in patients with lower levels of HER2 expression who received the AE37 vaccine; i.e., in patients who are not eligible for the drug Herceptin (which also targets the HER2 protein). In particular, the most favorable results were observed in patients with triple negative breast cancer. Patients with this type of cancer are not eligible for either Herceptin or hormone therapy and thus constitute one of the greatest areas of unmet need among breast cancer patients.
The first study, entitled "Biomarker Correlation to Clinical Response in a Phase II Trial of the HER2 Peptide Vaccine (AE37+GM-CSF)", by Schneble et al, is being given as a podium presentation. In that study, the extent of the local reaction to the vaccine as well as the presence of specific T cells in the blood that had been specifically activated by AE37 was measured. The study found that for patients who had a more robust response to the vaccine (above the median response) there was a significantly reduced incidence of relapse compared to those who developed weaker responses.
The second presentation, entitled "Clinical benefit and safety of boosting the HER2 peptide vaccine (AE37+GM-CSF) in the adjuvant setting to prevent breast cancer recurrence", also by Schnebel et al, assessed the impact of AE37 booster immunizations on reducing the risk of recurrence. The study concludes that the trend toward reduced relapse is strongest in patients who have received boosters.
Taken together, the newly reported studies provide important new data correlating immunological response to AE37 with clinical response. The new studies are based on patient data from a controlled, randomized and single-blinded Phase II trial assessing the efficacy of the AE37 vaccine in patients with early stage breast cancer. The conclusions corroborate prior results from a Phase I trial of AE37 in patients with prostate cancer. Immunological response data from that trial similarly showed a trend toward improved disease-free and overall survival in patients who developed a more robust response to the AE37 vaccine.
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. 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 technologies in immunotherapy. One focuses on modification of peptides with Ii-Key to increase potency, while a second 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.
Cautionary Note Regarding Forward-Looking Statements
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," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" 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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