OncoGenex Pharmaceuticals receives CHMP advice on OGX-011 development plan in treatment of mCRPC
November 13, 2015
"The agreement from both FDA and EMA on our Phase III clinical trial designs and analyses plans confirms our clinical development strategy and gives us a clear path to proceed," said Cindy Jacobs, MD, Ph.D., Executive Vice President and Chief Medical Officer at OncoGenex Pharmaceuticals. "We intend to open both Phase III clinical trials in Europe as well as in the United States and Canada, representing an expansion of our clinical development effort."
Teva Pharmaceutical Industries Ltd. and OncoGenex Pharmaceuticals, Inc. entered into a global license and collaboration agreement to develop and commercialize OGX-011. Teva and OncoGenex are collaborating on a global Phase III clinical program, with two Phase III clinical trials expected to be initiated in 2010: a Phase III study for second-line chemotherapy in men with metastatic castrate resistant prostate cancer (CRPC) and a Phase III study in first-line chemotherapy for metastatic CRPC. An additional Phase III study in first-line treatment of advanced, unresectable non-small cell lung cancer (NSCLC) is intended to be initiated by early 2011.
Source: ONCOGENEX PHARMACEUTICALS, INC.