Additional Relevant Details The INSPIRE trial is a global, multi-center, randomized controlled study to assess the efficacy and safety of IV rigosertib in HR-MDS patients under 80 years of age who had progressed on, or failed to respond to, or relapsed after previous treatment with HMAs.  For these patients who have failed treatment with an HMA, there is a significant unmet medical need because there is no alternative available therapy.  The INSPIRE trial is now enrolling higher-risk MDS patients who have failed all approved therapies, at multiple U.S. sites, and the Company is initiating additional clinical centers in the U.S. and abroad.
Until the August 30, 2016 termination date, Baxalta is obligated to provide various financial contributions, including 50 percent of the clinical trial costs for the INSPIRE trial up to a specified cap. Onconova is currently in discussions with Baxalta regarding the amount of financial support sufficient to complete the INSPIRE trial that was commenced in December following consultation with Baxalta.