Onconova Therapeutics has announced that it is advancing the oral formulation of rigosertib (Estybon, ON 01910.Na), an anti-cancer agent, into a new Phase 2 study.

Rigosertib is a small molecule inhibitor of critical pathways, important in the growth and survival of cancer cells and is currently in a pivotal Phase 3 trial for refractory myelodysplastic syndromes (MDS) in the US and European Union.

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The Phase 2 study follows a Phase 1 dose escalation study in MDS patients where orally-administered rigosertib showed bone marrow responses in high-risk patients who were refractory to hypomethylating agents, a reduction in need for red blood cell transfusions in transfusion-dependent patients, and a transition to transfusion independence.

Principal investigator of the study, assistant professor of medicine at Columbia University and staff physician at Herbert Irving Comprehensive Cancer Center of Columbia University Medical Center/New York-Presbyterian Hospital in New York, Siddhartha Mukherjee, said a randomised Phase 2 evaluation of oral rigosertib will be conducted in patients with low or intermediate-1 risk, transfusion-dependent myelodysplastic syndromes at Columbia University Medical Center.

"The objective of the study is to determine if oral rigosertib will reduce the need for blood transfusions in transfusion-dependent MDS patients. The need for blood transfusions and the complications from receiving transfusions are serious medical issues for these patients," Mukherjee added.

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Columbia University Medical Center medicine professor Azra Raza said the reduction in RBC transfusions observed in the study was a breakthrough.

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"Confirmation of these findings in the Phase 2 study will be a significant step forward, potentially leading to a safe and effective treatment for patients with low-risk MDS," Raza added.

The ongoing Phase 3 ON 01910.Na trial in myelodysplastic syndrome (ONTIME) study is a pivotal, multicentre, randomised trial, comparing rigosertib with best supportive care to best supportive care alone, in high-risk MDS patients with excess blasts, who are refractory, intolerant to, or have relapsed after azacitidine or decitabine treatment.