Cornerstone to Conduct Phase I/II Cancer Trial

Cornerstone Pharmaceuticals has received FDA clearance to begin a Phase I/II clinical trial evaluating its Altered Energy Metabolism-Directed compound, CPI-613, in multiple cancer types.

The open-label, dose-escalation trial will evaluate safety, tolerability, maximum-tolerated dose, efficacy and pharmacokinetics of the drug in various types of cancer patients. In preclinical studies, the compound targeted distinctive changes in the energy-generating processes associated with the majority of solid tumor types, Cornerstone said.

The compound has been granted orphan drug status for treating pancreatic cancer.