CytRx Reports Update For Phase 2 Leukemia Trial With Tamibarotene

Published: 29-Jun-2009

Trial to determine rate of durable complete response for tamibarotene therapy

CytRx has 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 (APL).

The primary endpoint of the 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.

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 responsem, said the company.

Steven Kriegsman, President and CEO, CytRx, said: “We are highly encouraged by the trial patients’ response to tamibarotene, with five of the 11 APL patients, or 45%, achieving MLFS after failing on two other drug therapies.”

“We are aggressively working to achieve our goal of completing this trial by the end of the current year, which may include acceleration of the trial through a negotiation with the FDA regarding the total number of patients ultimately enrolled, and filing an NDA submission with the FDA in 2011,” he added.

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