Onconova Therapeutics Inc., a biotech company in Newtown, Pennsylvania, says it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the design of a Phase 3 clinical trial for the company’s drug Estybon. The drug is a monotherapy for patients with myelodysplastic syndromes (MDS), diseases affecting the production of healthy blood cells in the bone marrow.
The SPA provides FDA evaluation and acceptance of a clinical trial protocol, including trial size, clinical endpoints, and data analysis, and provides further agreement that the Phase 3 study design adequately addresses objectives in support of a regulatory submission.
Onconova says the Estybon MDS trial will be conducted in the U.S. and Europe and will enroll patients with excess immature blood cells (blasts) who are resistant or intolerant to or have relapsed after treatment with currently approved treatments. The Onconova trial will compare the efficacy and safety of Estybon to “best supportive care,” defined as the use of drugs and other treatments to improve the quality of life of patients. Patient enrollment in the U.S. is expected to begin later in 2010.
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