Generex Biotechnology Receives IND Approval from FDA for Phase II Combination Study using AE37 plus Keytruda® (pembrolizumab) for the Treatment of Triple Negative Breast Cancer
GENEREX BIOTECHNOLOGY (GNBT)
US:NASDAQ Investor Relations:
generex.com/investor
Company Research
Source: Business Wire
MIRAMAR, Fla.--(BUSINESS WIRE)-- Generex Biotechnology Corporation (OTCQB:GNBT) today announced that the FDA had reviewed the company’s investigational new drug (IND) application and given notification that the study can proceed. The study: A Phase II Clinical Trial of Pembrolizumab (Keytruda®) in Combination with the AE37 Peptide Vaccine in Patients with Metastatic Triple Negative Breast Cancer, is sponsored by Generex and conducted under a collaboration agreement with Merck and a clinical trial agreement with the NSABP Foundation, Inc. (NSABP). The combination study builds on previous clinical studies of both AE37 and Keytruda®. AE37, a cancer vaccine, was the subject of a 300 patient prospective, randomized and single-blinded Phase II study in patients with breast cancer. That study showed a strong trend toward reduced relapses,particularly in patients with triple negative breast cancer. Keytruda® als
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