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'lizbeth · 05-27-2014, 10:05 AM

Generex Announces Presentation of Primary Efficacy Data & Immunological Response from the Phase II Study of AE37 Cancer Vaccine at ASCO

WORCESTER, Mass. and TORONTO, May 20, 2014 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (GNBT) today announced two upcoming presentations demonstrating that certain patients with early stage breast cancer who receive AE37 may benefit in terms of reduced risk of relapse. The AE37 breast cancer vaccine is being developed by the Company's wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com). The presentations will be made at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) to be held in Chicago from May 30 through June 3, 2014.

The Company recently reported completion of accrual to a prospective, randomized, controlled and single-blinded Phase II study of AE37 in newly diagnosed breast cancer patients. Prior interim analysis revealed a strong trend toward reduction of relapse in patients with low to intermediate levels of HER2 expression.

AE37 was designed to generate a robust response to the HER2 protein, particularly in CD4+ T helper cells, which have been shown to be critical in the generation of a new immune response. The results of two Phase I studies, in breast and prostate cancer patients respectively, previously demonstrated robust and specific immune stimulation. AE37 has been shown to be safe and well-tolerated by patients in all trials.

The first presentation entitled "Primary analysis of the prospective, randomized, single-blinded phase II trial of AE37 vaccine vs GM-CSF alone administered in the adjuvant setting to high risk breast cancer patients" by Mittendorf et al, demonstrates that patients with low to intermediate levels of HER2 expression displayed a trend toward benefit from the AE37 vaccine, as was initially observed from the interim analysis of the same study. In particular, patients with triple negative breast cancer appeared to derive the greatest benefit. Patients in the low HER2 group exhibited a 40% decrease in the risk of relapse (p=0.21) while those with triple negative cancer exhibited a 60% decreased risk (p=0.12).

The second presentation, entitled "Immunogenic Comparison of Recurrent and Non-Recurrent Breast Cancer Patients Undergoing AE37 Peptide Vaccine Therapy" by Schnebel et al, showed a correlation between the magnitude of immunological response to AE37 and the tendency to relapse. Prior studies have shown that AE37 generates a more robust immune response than other HER2 targeted peptide vaccines, with AE37 being the only vaccine capable of generating a specific immunogenicity in the absence of GM-CSF adjuvant.

"We remain encouraged by the overall AE37 clinical data package" said Dr. Eric von Hofe, Ph.D., President of Antigen Express. "The robustness of the immunological response, together with a trend toward reduced relapse in patients with low HER2 expression, and particularly those with triple-negative breast cancer, is promising," he continued. The lack of effective treatments for triple negative breast cancer patients has long been recognized as a major area of unmet medical need.

05-27-2014, 10:05 AM	#1
'lizbeth Senior Member Join Date: Apr 2008 Location: Sunny San Diego Posts: 2,214	Generex Announces Presentation of Primary Efficacy Data & Immunological Response from Generex Announces Presentation of Primary Efficacy Data & Immunological Response from the Phase II Study of AE37 Cancer Vaccine at ASCO WORCESTER, Mass. and TORONTO, May 20, 2014 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (GNBT) today announced two upcoming presentations demonstrating that certain patients with early stage breast cancer who receive AE37 may benefit in terms of reduced risk of relapse. The AE37 breast cancer vaccine is being developed by the Company's wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com). The presentations will be made at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) to be held in Chicago from May 30 through June 3, 2014. The Company recently reported completion of accrual to a prospective, randomized, controlled and single-blinded Phase II study of AE37 in newly diagnosed breast cancer patients. Prior interim analysis revealed a strong trend toward reduction of relapse in patients with low to intermediate levels of HER2 expression. AE37 was designed to generate a robust response to the HER2 protein, particularly in CD4+ T helper cells, which have been shown to be critical in the generation of a new immune response. The results of two Phase I studies, in breast and prostate cancer patients respectively, previously demonstrated robust and specific immune stimulation. AE37 has been shown to be safe and well-tolerated by patients in all trials. The first presentation entitled "Primary analysis of the prospective, randomized, single-blinded phase II trial of AE37 vaccine vs GM-CSF alone administered in the adjuvant setting to high risk breast cancer patients" by Mittendorf et al, demonstrates that patients with low to intermediate levels of HER2 expression displayed a trend toward benefit from the AE37 vaccine, as was initially observed from the interim analysis of the same study. In particular, patients with triple negative breast cancer appeared to derive the greatest benefit. Patients in the low HER2 group exhibited a 40% decrease in the risk of relapse (p=0.21) while those with triple negative cancer exhibited a 60% decreased risk (p=0.12). The second presentation, entitled "Immunogenic Comparison of Recurrent and Non-Recurrent Breast Cancer Patients Undergoing AE37 Peptide Vaccine Therapy" by Schnebel et al, showed a correlation between the magnitude of immunological response to AE37 and the tendency to relapse. Prior studies have shown that AE37 generates a more robust immune response than other HER2 targeted peptide vaccines, with AE37 being the only vaccine capable of generating a specific immunogenicity in the absence of GM-CSF adjuvant. "We remain encouraged by the overall AE37 clinical data package" said Dr. Eric von Hofe, Ph.D., President of Antigen Express. "The robustness of the immunological response, together with a trend toward reduced relapse in patients with low HER2 expression, and particularly those with triple-negative breast cancer, is promising," he continued. The lack of effective treatments for triple negative breast cancer patients has long been recognized as a major area of unmet medical need.