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ARTICLE | Clinical News

Curis slides on partial clinical hold for CUDC-427

November 7, 2013 1:36 AM UTC

Curis Inc. (NASDAQ:CRIS) fell $1.03 (26%) to $2.86 on Wednesday after FDA placed a partial clinical hold on a Phase I trial evaluating the company's CUDC-427 to treat solid tumors or lymphoma. FDA placed the hold after a patient died from liver failure a month after discontinuing treatment with CUDC-427. According to Curis, the patient developed serious adverse events related to liver function, including elevated levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin that did not improve after discontinuing CUDC-427. Curis said no patients are currently being treated with CUDC-427, as all nine patients enrolled in the trial have discontinued treatment with the small molecule inhibitor of apoptosis (IAP) proteins due to disease progression or physician discretion. The company said it plans to submit additional data and analysis requested by FDA as well as a protocol amendment for the Phase I trial, but declined to provide a timeframe. ...