Onconova Therapeutics (ONTX) Completes End-of-Phase 2 Meeting w/ FDA for Oral Rigosertib and Azacitidine

September 26, 2016 7:05 AM EDT

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Onconova Therapeutics, Inc. (Nasdaq: ONTX) announced receipt of the End-of-Phase 2 meeting minutes from the U.S. Food and Drug Administration (FDA) for the combination of oral rigosertib with azacitidine for the treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS).

Based on these discussions, Onconova will design a randomized, controlled Phase 3 clinical trial comparing the combination of oral rigosertib plus azacitidine to azacitidine plus placebo in 1st-line HR-MDS patients. The primary endpoint of this pivotal trial will be overall response rate (ORR); ORR will be a composite of complete remission (CR) and partial remission (PR). Onconova could potentially pursue additional available paths from FDA for accelerated or enhanced review and further input on the development of a final trial protocol. Full details of the protocol will be available following completion of all regulatory discussions.

As part of the End-of-Phase 2 meeting with FDA, Onconova presented updated results from its Phase 2 trial of oral rigosertib and azacitidine. These results are expected to be presented by study investigators at a scientific conference later this year.

“We are encouraged that our interactions with FDA resulted in agreement on the patient population to be evaluated and the selection of overall response as the primary endpoint in this pivotal trial,” stated Steven Fruchtman, M.D., Chief Medical Officer of Onconova. “We will provide additional details on the design of this trial and the full Phase 2 data set supporting our pivotal study plans at upcoming meetings and scientific conferences later in 2016.”

Onconova is developing rigosertib for patients with MDS where there is a paucity of therapeutic options. Two hypomethylating agents (HMAs), azacitidine and decitabine, the mainstays for eligible 1st-line patients, were approved by the FDA more than a decade ago. In addition to the oral rigosertib and azacitidine combination program, Onconova is currently enrolling patients in the global, pivotal Phase 3 INSPIRE trial of IV rigosertib for 2nd-line MDS patients, who have failed HMA therapy. This trial of 225 patients is now enrolling in the U.S., Europe, Japan and Australia.

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