Phase 2 study of tamibarotene for relapsed acute promyelocytic leukemia (APL)

CytRx Corporation announced favorable preliminary results from its Phase 2 STAR-1 registration clinical trial for tamibarotene in the treatment of acute promyelocytic leukemia (APL) in patients failing other treatments.  This study was an open-label, non-randomized trial, with a primary endpoint of determining the rate of durable complete response for tamibarotene therapy when administered as a single agent to adult patients following treatment failure with all-trans retinoic acid (ATRA) and arsenic trioxide. Trial patients were administered 6 mg of tamibarotene daily until they achieved remission or for a maximum of 56 days. From the results of eleven patients who had received a median of seven prior therapies, three patients (27%) achieved a hematologic complete response, and four (36%) achieved a morphologic leukemia-free state.

Tamibarotene is an orally available, rationally designed, synthetic retinoid compound which was designed to potentially avoid toxic side effects by binding to its molecular target more selectively than all trans-retinoic acid (ATRA), the current first line treatment for APL.

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