FDA Removes Partial Clinical Hold On Curis' CUDC-427 - Quick Facts

(RTTNews) - The U.S. Food and Drug Administration or FDA has notified Curis, Inc. (CRIS) that its complete response submission to the November 2013 partial clinical hold on CUDC-427 has been reviewed and that the FDA has determined that it is safe to proceed under the IND. Further, the FDA indicated that detailed official correspondence on the determination would be released in the near future. Curis would issue additional details, if applicable, based on further communications from the FDA as they become available.

CUDC-427 is an oral, small molecule Smac mimetic that is designed to promote cancer cell death by antagonizing inhibitor of apoptosis proteins.

Ali Fattaey, President and Chief Operating Officer of Curis, noted: "We continue to believe that CUDC-427 has significant potential as an anti-cancer agent and expect to proceed with CUDC-427's overall development plan, including our planned study to investigate CUDC-427 in combination with capecitabine in HER-2 negative advanced breast cancer patients."

In November 2013, CUDC-427's Phase 1 trial in patients with solid tumors or lymphoma was placed on partial clinical hold following the death of a patient, who progressed to liver failure nearly a month following the discontinuation of CUDC-427 dosing. As per the partial clinical hold, no new patients were enrolled in the study until Curis provided the FDA with the requested data and analyses of all patients treated with CUDC-427, along with a protocol amendment found to be acceptable to the FDA.