Onconova completes patient enrollment in Phase 3 study of cancer drug

Rigosertib inhibits phosphoinositide 3-kinase and polo-like kinase, the two important cellular signaling pathways frequently activated in cancer cells.

The patients who failed previous therapy with hypomethylating agents such as azacitidine and decitabine were enrolled in the study.

Onconova chief executive officer Ramesh Kumar said at present very limited treatment options are available for high-risk MDS patients who fail hypomethylating agents.

"We are developing rigosertib as a second-line therapy for this patient population," Kumar added.

"We expect to present top-line survival results from this study either in the fourth quarter of 2013 or the first quarter of 2014."

The randomised controlled study of rigosertib is being conducted in the US and five EU countries under a Special Protocol Assessment from the FDA and under Scientific Advice from the European Medicines Agency.

Both groups of patients in the ONTIME trial received best supportive care and the active treatment group of patients also received rigosertib, according to the company.

The overall survival is the primary objective of the ONTIME trial.

Secondary objectives are evaluation of bone marrow, cytogenetic and blood profiles, quality of life scores and time to transition to acute myelogenous leukemia.