Pivotal meeting

How Cornerstone’s CPI-613 leapfrogged to pivotal trials in AML, pancreatic cancer

Cornerstone Pharmaceuticals Inc. was planning a traditional development pathway for CPI-613 in acute myelogenous leukemia and pancreatic cancer, but FDA nudged the company to go from Phase I to pivotal trials for both indications.

According to COO Sanjeev Luther it was FDA, not the company, that suggested an accelerated development timeline based on the strength of the Phase I data.

Cornerstone is finalizing its pivotal study protocols and plans to launch two trials this year to evaluate CPI-613 plus standard of care (SOC). One will enroll relapsed and refractory AML patients aged 60 and older, and the other newly diagnosed stage IV pancreatic cancer patients.

CPI-613 is an analog of alpha-lipoic acid that disrupts abnormal metabolic pathways specific to cancer cells.

In normal cells, the primary metabolic goal is to generate energy in the form of ATP, which is produced in mitochondria. In most types of

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