On August 13, 2015 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for IV rigosertib as a treatment for higher-risk myelodysplastic syndromes (HR-MDS) after failure of hypomethylating agent (HMA) therapy (Press release, Onconova, AUG 13, 2015, View Source [SID:1234507256]). Upon clearance, the IND enables Onconova to initiate a randomized, controlled pivotal Phase 3 trial in patients with HR-MDS that have failed prior HMA therapy. Schedule your 30 min Free 1stOncology Demo! "We are pleased to achieve this important milestone, which positions rigosertib back on an approval track in HR-MDS," said Ramesh Kumar, Ph.D., President and CEO of Onconova. "We plan to submit Clinical Trial Applications (CTAs) in several European countries shortly. Onconova anticipates initiating enrollment in the new Phase 3 study in the second half of 2015."
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The pivotal trial, designated 04-30 or "INSPIRE", will enroll HR-MDS patients under 80 years of age who had progressed on, or failed to respond to, previous treatment with HMAs within the first nine months of initiation of HMA treatment, and had their last dose of HMA therapy within six months prior to enrollment in the trial. The primary endpoint of this study will be overall survival, and an interim analysis is anticipated. This randomized trial of approximately 225 patients will be conducted at about 100 sites globally. Enrollment in this trial is expected to begin later this year, though the ability to conduct the trial as planned will require additional financing.