PHARMA/BIOTECH UPDATE: New England Based Onconova Announces Results from Phase 3 Trial
February 21, 2014; Posted by: WeBleed staff
Onconova Therapeutics, Inc announced the results of the Phase 3 trial of its intravenous (IV) drug for the rare family of blood disorders called myelodysplastic syndromes (MDS, formerly referred to as pre-leukemia). The drug, rigosertib, did not meet the primary goal of improving the overall survival rate of patients who had already tried currently available best supportive care.
The pharmaceutical company did, however, mention that an analysis after the fact has shown a statistically significant increase in the median survival rate of patients previously treated unsuccessfully with hypomethylating agents.
“We are working closely with our partners, Baxter and SymBio, as we evaluate the results of this study. We plan to engage with the U.S. Food and Drug Administration (FDA) and European regulatory agencies with the goal of determining the next steps in advancing development of rigosertib for this underserved patient population,” said Ramesh Kumar, Ph.D., President & CEO of Onconova via the company’s press release. “Ongoing efforts include trials of oral rigosertib in transfusion-dependent lower risk MDS patients, where, after consultation with regulatory agencies, we are planning to initiate a Phase 3 trial as soon as possible.”
Further Reading: About Onconova; hypomethylating agents
