On March 31, 2014 Curis reported that the U.S. Food and Drug Administration (FDA) has notified the Company 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 (Press release Curis, MAR 31, 2014, View Source [SID:1234500345]). The FDA also indicated that detailed official correspondence regarding the determination will be released in the near future. Curis will provide additional details, if applicable, based upon further communications from the FDA as they become available.
In November 2013, CUDC-427’s Phase 1 study (NCT01908413) in patients with solid tumors or lymphoma was placed on partial clinical hold following the death of a patient who progressed to liver failure approximately one month following the discontinuation of CUDC-427 dosing. Under the partial clinical hold, no new patients were to be enrolled in the study until Curis provided the FDA with the requested data and analyses of all patients treated with CUDC-427, together with a protocol amendment found to be acceptable to the FDA.