Onconova Therapeutics, Inc. Moves Forward with Phase 3 Inspire Pivotal Trial with Increased Sample Size Following Promising Interim Analysis
January 17, 2018 at 06:00 pm IST
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Onconova Therapeutics, Inc. announced that it is moving forward with its Phase 3 INSPIRE pivotal trial following the interim analysis, consistent with the DMC’s recommendation. The DMC recommended continuation of the trial with a one-time expansion in enrollment, using a pre-planned sample size re-estimation, consistent with the Statistical Analysis Plan (SAP). The INSPIRE pivotal trial is studying intravenously-administered (IV) rigosertib in patients with higher-risk myelodysplastic syndromes (MDS) who have progressed on, failed to respond to, or relapsed after prior hypomethylating agent (HMA) therapy. The Company remains blinded to the interim analysis results. The SAP for the INSPIRE trial featured an adaptive trial design, permitting several options following the interim analysis, which included continuation of the trial as planned, discontinuation of the trial for futility, trial expansion using pre-planned sample size re-estimation, and trial continuation for only the pre-defined treatment subgroup of patients classified as VHR based on the Revised International Prognostic Scoring System (IPSS-R). The expanded INSPIRE study will continue to enroll eligible patients based on the current trial design of the overall ITT population and will increase enrollment by adding 135 patients to the original target to reach a total enrollment of 360 patients, with the aim of increasing the power of the trial.
Traws Pharma, Inc., formerly Onconova Therapeutics, Inc., is a virology and oncology company. The Company is engaged in developing antivirals for influenza, COVID and other respiratory infections and narazaciclib. Its proprietary portfolio includes, TRX100 (viroksavir), TRX01 (travaltrevir), and Narazaciclib. Viroksavir is a cap-dependent endonuclease inhibitor for influenza. Travaltrevir is a Mpro protease inhibitor for COVID19. Narazaciclib is a cyclin-dependent kinases (CDK) 4/6 inhibitor for low-grade endometrioid endometrial cancer (LGEEC). Narazaciclibâs mechanism of action in LGEEC is validated by phase II studies with other approved CDK4/6 inhibitors: palbociclib, ribociclib, and abemaciclib. Narazaciclib is in phase I/IIa study to define the Phase II dose (RP2D).