Tamibarotene: Phase II data

In the ongoing, open-label, U.S. Phase II STAR-1 trial, a 44-year old female APL patient who failed treatment with all-trans retinoic acid (ATRA) and arsenic trioxide achieved molecular complete remission with no evidence of disease in blood cells or bone marrow after 56 days of treatment with once-daily oral tamibarotene. Furthermore, the response was maintained at 6 months post-treatment. Data were published in the British Journal of Haematology. CytRx previously reported data from 11 relapsed/refractory patients who failed treatment with ATRA and arsenic trioxide showing that 6 mg/m 2 once-daily oral tamibarotene produced a hematologic complete response in 3 patients, with 4 patients achieving a MLFS (see BioCentury, Dec. 14, 2009). The company has an SPA from FDA for the trial. ...