CytRx (CYTR) Reports Favorable Progress Update for Ongoing Phase 2 STAR-1 Trial of Tamibarotene
CytRx Corporation (NASDAQ: CYTR) today provided a favorable progress update for its ongoing Phase 2 STAR-1 registration clinical trial to evaluate the efficacy and safety of orally administered tamibarotene as a third-line treatment for acute promyelocytic leukemia.
The primary endpoint of the open-label, non-randomized STAR-1 trial is to determine 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 and arsenic trioxide. A durable complete response is achieved when no leukemia cells can be found in the bone marrow (morphologic leukemia-free state or MLFS), the patient's neutrophil and platelet counts (blood cells) are increased to a certain level, and there is no sign of disease outside of the blood and bone marrow. All of these criteria must be satisfied for at least 28 days to be considered a durable complete response.
Of the 11 patients enrolled in the STAR-1 trial to date, two patients have achieved durable complete response and one has achieved MLFS, but withdrew from the trial to receive a bone marrow transplant before the durable complete response could be confirmed. One patient achieved a complete response, but did not maintain MLFS for the required 28 days to be considered a durable complete response. Another patient achieved a durable MLFS, but did not have the necessary increases in blood cells to be considered a durable complete response.
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