Onconova Presents Phase I Data for Oral Rigosertib at the 53rd ASH Annual Meeting
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SymBio Pharmaceuticals Limited has announced that Onconova Therapeutics®, Inc. presented positive data from its US Phase I trial in myelodysplastic syndrome (MDS) patients treated with oral rigosertib (ON 01910.Na) at the 53rd American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, CA on December 12, 2011.
SymBio signed a license agreement with Onconova in July, 2011, for the exclusive right to develop and commercialize both the intravenous and oral forms of rigosertib in Japan and Korea.
An oral dosage form of rigosertib has completed a Phase I dose escalation trial with 33 MDS patients in the U.S.
The rigosertib capsule formulation was well tolerated and pharmacodynamically relevant doses were achieved in MDS patients with encouraging signs of clinical activity observed, including two cases of bone marrow responses in higher-risk patients refractory to hypomethylating agents, reduced need for red cell transfusions in low-risk, transfusion-dependent patients, and transition to transfusion independence in some patients.
Based on these results, Phase II studies will be conducted using oral rigosertib in Low or Intermediate-1 risk, transfusion-dependent MDS patients.
Onconova is conducting late-stage clinical trials with rigosertib, a patent protected multi-kinase inhibitor with a unique mode of action, in the U.S., Europe and India for the treatment of MDS and solid tumors.
A pivotal Phase III trial in the refractory/relapsed MDS clinical program is underway in the U.S. and Europe.
SymBio is now preparing to initiate a Phase I clinical trial in Japan and Korea for the treatment of refractory/relapsed MDS patients using the intravenous form (SyB L-1101) of rigosertib, with the treatment of frontline MDS using the oral form (SyB C-1101) to follow based on results generated in US Phase II clinical trials.
