Onconova Therapeutics, Inc., a clinical-stage biopharmaceutical company, announced Thursday it has filed clinical trial applications with the UK, German and Austrian regulatory agencies for IV rigosertib as a treatment in higher-risk myelodysplastic syndromes patients after failure of a hypomethylating agent therapy.
“These filings follow our recent updated IND submission to the U.S. FDA,” Ramesh Kumar, president and CEO of Onconova, said. “Together, acceptance of these regulatory filings will allow Onconova to initiate a single global pivotal trial for IV rigosertib in HR-MDS. We anticipate enrollment in the new Phase 3 study will begin in the second half of 2015.”
Onconova has partnered with SymBio Pharmaceuticals, Ltd. for clinical development of rigosertib in Japan and Korea. SymBio plans to participate in the global Phase 3 trial by enrolling patients in Japan.
"We completed a Phase 1 trial for oral rigosertib (SyB C-1101) in relapsed or refractory MDS last June and expect to complete the ongoing Phase 1 trial for IV rigosertib (SyB L-1101) in the treatment of relapsed or refractory HR-MDS patients this October," Fuminori Yoshida, president and CEO of SymBio, said. "After consulting with the PMDA (Japanese Pharmaceuticals and Medical Devices Agency), it is our plan to participate in the global 04-30 trial, and to begin enrolling patients in Japan for this unmet medical need in HR-MDS.”