Cornerstone to start pivotal trials in AML, pancreatic cancer

Cornerstone Pharmaceuticals Inc. (Cranbury, N.J.) plans to start two pivotal studies this year of lead candidate CPI-613 to treat relapsed/refractory acute myelogenous leukemia (AML) patients aged 60 and older and stage IV pancreatic cancer patients.

The company reported Phase I data from both programs last year. COO Sanjeev Luther said Cornerstone's decision to pursue pivotal studies immediately was based on discussions with FDA during end-of-Phase I meetings. ...