Onconova Therapeutics, Inc. Submits Pivotal Clinical Trial Protocol for IV Rigosertib in Higher-Risk Myelodysplastic Syndromes to FDA and EMA

Onconova Therapeutics, Inc.

, a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced that the Company has submitted a protocol for a global pivotal study of IV rigosertib in patients with higher-risk myelodysplastic syndromes (HR-MDS) for whom prior treatment with approved hypomethylating agents has failed for regulatory review. Parallel submissions were made to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The new Phase 3 randomized controlled trial of IV rigosertib derives from the findings of the ONTIME trial and is based on guidance received from previous consultations with FDA and EMA. The protocol includes a subgroup of HR-MDS patients, identified from an analysis of the ONTIME trial, who demonstrated an encouraging improvement in overall survival compared to the control arm. Based on previous guidance received from both FDA and EMA, and following discussions with key opinion leaders in the U.S. and Europe, the proposed primary endpoint for the new trial is overall survival. Additional details of the trial design and plan, including postings on national clinical trials registration databases, will be available following completion of the regulatory review process in the U.S. and Europe. Pending regulatory review and appropriate financing, international clinical trial sites are expected to be opened for enrollment into this new study during the second half of 2015.