MIRAMAR, Fla., Sept. 17, 2019 (GLOBE NEWSWIRE) --
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Posted On: 09/17/2019 9:13:18 AM
MIRAMAR, Fla., Sept. 17, 2019 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that the NSABP Foundation, Inc. (NSABP) has enrolled the first patient in the study: A Phase II Clinical Trial of Pembrolizumab in Combination with the AE37 Peptide Vaccine in Patients with Metastatic Triple Negative Breast Cancer (NSABP FB-14). The trial, conducted in conjunction with research partners Merck and the NSABP Foundation, is designed to evaluate the safety and tolerability of AE37 given in combination with KEYTRUDAÒ (pembrolizumab) as well as the objective response rate.
Eric von Hofe, President of NuGenerex-ImmunoOncology commented, “This is an exciting milestone for NuGenerex Immuno-Oncology, as we have now revitalized our AE37 development program with a focus on combination therapy with checkpoint inhibitors, which are now becoming standard of care for a broad array of cancers. Combining our promising immunotherapeutic with Merck’s checkpoint inhibitor, KEYTRUDA for the treatment of triple negative breast cancer represents a novel treatment strategy for a cancer of high unmet need. Prior studies with each agent alone showed promising signs of efficacy. By combining the mechanisms of checkpoint inhibition by KEYTRUDA with the robust, long-lasting and tumor-specific T-cell activation by AE37, we hope to enhance the clinical effectiveness of the immunotherapy strategies.”
Jason Terrell, MD, Chief Scientific and Medical Officer of Generex Biotechnology commented, “The start of patient enrollment represents the culmination of a committed effort by the team at NuGenerex Immuno-Oncology (formerly Antigen Express) and our research partners at the NSABP Foundation and Merck. NuGenerex Immuno-Oncology has been a pioneer on the forefront of immunotherapy for over a decade with our Ii-Key platform that ensures CD4 T-cell activation against any tumor antigen to which the Ii-Key is attached. The Ii-Key platform holds great promise, and we plan to initiate additional trials using the combination of checkpoint inhibitors with AE37 immune system activation in the field of personalized immuno-oncology to help patients in need of treatment options.”
Eric von Hofe, President of NuGenerex-ImmunoOncology commented, “This is an exciting milestone for NuGenerex Immuno-Oncology, as we have now revitalized our AE37 development program with a focus on combination therapy with checkpoint inhibitors, which are now becoming standard of care for a broad array of cancers. Combining our promising immunotherapeutic with Merck’s checkpoint inhibitor, KEYTRUDA for the treatment of triple negative breast cancer represents a novel treatment strategy for a cancer of high unmet need. Prior studies with each agent alone showed promising signs of efficacy. By combining the mechanisms of checkpoint inhibition by KEYTRUDA with the robust, long-lasting and tumor-specific T-cell activation by AE37, we hope to enhance the clinical effectiveness of the immunotherapy strategies.”
Jason Terrell, MD, Chief Scientific and Medical Officer of Generex Biotechnology commented, “The start of patient enrollment represents the culmination of a committed effort by the team at NuGenerex Immuno-Oncology (formerly Antigen Express) and our research partners at the NSABP Foundation and Merck. NuGenerex Immuno-Oncology has been a pioneer on the forefront of immunotherapy for over a decade with our Ii-Key platform that ensures CD4 T-cell activation against any tumor antigen to which the Ii-Key is attached. The Ii-Key platform holds great promise, and we plan to initiate additional trials using the combination of checkpoint inhibitors with AE37 immune system activation in the field of personalized immuno-oncology to help patients in need of treatment options.”
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