OncoGenex Pharmaceuticals (NASDAQ: OGXI) announced today that it has received written, scientific advice from the European Medicines Agency (EMA) on the company's development plan for OGX-011 (also known as custirsen) for the treatment of men with metastatic castrate-resistant prostate cancer (mCRPC). 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. The company'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 Food and Drug Administration (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.