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news.OncoGenex Pharmaceuticals has received written, scientific advice from the European Medicines Agency (EMA) on its development plan for OGX-011 (custirsen) for the treatment of men with metastatic castrate-resistant prostate cancer (mCRPC).
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The input received from the Committee for Medicinal Products for Human Use (CHMP) at the EMA was in overall agreement with OncoGenex’s development plan regarding the proposed preclinical studies and both the study designs and analyses for the Phase III trials. The CHMP also agreed that the intended safety database would enable a sufficiently qualified risk-benefit assessment for market approval.
OncoGenex sought to obtain the EMA’s opinion on the specific design for the clinical and preclinical studies required for European approval as well as the statistical analyses of Phase III trials.
OncoGenex’s proposed development plan involved initial approval in Europe based upon a single Phase III trial evaluating the potential survival benefit of custirsen when used in combination with first-line chemotherapy (Phase III Study OGX-011-11) and a label expansion based upon a supportive trial evaluating the potential of custirsen to provide the clinical benefit of durable pain palliation when used in combination with second-line chemotherapy (Phase III Study OGX-011-10).
OncoGenex Pharmaceuticals had previously announced completion of the following two Special Protocol Assessment (SPA) agreements with the FDA for the two Phase III trials: the SPA for Study OGX-011-10 that was announced on April 28, 2009 and the SPA for Study OGX-011-11 that was announced on June 24, 2009.
Cindy Jacobs, executive vice president and chief medical officer at OncoGenex Pharmaceuticals, said: “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. 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.”
Reportedly, Teva Pharmaceutical and OncoGenex Pharmaceuticals had 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.