FDA lifts a partial hold on Curis cancer drug

Lexington, MA-based Curis ($CRIS) says the FDA has lifted the partial clinical hold on CUDC-427, which was instituted after the death of a patient in a Phase I study of solid tumors and lymphoma. The biotech's stock popped early in the day but most of the gains quickly evaporated. The company snagged the drug in late 2012, paying Genentech $9.5 million up front and promising to pay milestones based on the first sales of an approved product. The drug (formerly GDC-0917) is designed to spur cancer cell death by blocking proteins that hit the brakes on apoptosis. "We have worked diligently with the FDA and anticipate re-opening the monotherapy Phase 1 study as soon as possible," said Curis President Ali Fattaey. "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." Release

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