According to an article in Globe NewsWire, Onconova Therapeutics, a biopharmaceutical company currently focusing on myelodysplastic syndromes, recently announced results of its Phase 1 study of oral rigosertib in combination with the hypomethylating agent azacitidine. This trial is Onconova’s first exploration into oral rigosertib combined with azacitidine.
Rigosertib is a small molecule that targets RAS effector pathways that are vital to cancer cells. The drug inactivates cellular signaling.
The combination is being investigated for use in the treatment of acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS). The study was published in the journal Leukemia Research.
About Onconova’s Phase I Study
The study involved patients with higher-risk MDS who had hypomethylating failure, relapsed MDS, or AML that were resistant to treatment (refractory).
The subjects in the Phase I trial were divided into three different groups, each with a different dose limit. No toxicities were reported that required a patient’s discontinuance of the trial.
The response rate for the oral rigosertib and azacitidine HR-MDS group was seventy-eight percent. The response rate for patients in the AML group was twenty-nine percent.
The study was dose-escalating and open-label whereby investigators and patients had knowledge of who received the drugs.
The dosing was sequential and escalated to the highest tolerable limits. In addition to exploring safety issues, the company focused on determining the recommended dosage for the Phase II trial and beyond.
Onconova’s Phase II study (NCT01926587)
The Phase II trial is still in effect for patients with higher-risk MDS.
In addition to exploring safety issues in the Phase I Trial, the company focused on determining the recommended dosage for the Phase II trial and beyond.
About the INSPIRE Phase III Trial
Onconova’s CEO anticipates a data readout in the near future regarding alignment with the FDA on the registration of its INSPIRE trial combining oral rigosertib and azacitidine in the treatment of newly-diagnosed high-risk MDS patients.
About Onconova Therapeutics, Inc.
Onconova Therapeutics, Newtown, Pennsylvania, specializes in the development of cancer treatments. Its focus at this time is on myelodysplastic syndromes.
The company is currently in the stage of clinical development with single-agent rigosertib administered intravenously (Phase III INSPIRE trial) and oral rigosertib in combination with azacitidine.
The officials at Onconova are very encouraged by the diversity of rigosertib and its convenience of administration which gives the drug potential as a partner in other combinations.
