FDA calls partial halt to Phase I trial of Curis cancer drug


The FDA has placed a partial clinical hold on the Phase I trial of Curis' (CRIS) CUDC-427 treatment for advanced and refractory solid tumors or lymphomas.

The FDA ordered the halt following the death a patient who suffered liver failure a month after discontinuing treatment with CUDC-427.

Curis won't be able to enroll new patients for the study until it has met various FDA requirements; all the subjects in the trial have stopped taking the drug due to disease progression, or patient or physician discretion

The company licensed CUDC-427 from Roche's (RHHBY) Genentech.

Curis' shares sink 10.5%.

Curis' Q3 results. (PR)

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