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news.Cornerstone Pharmaceuticals has received clearance from the FDA to begin a Phase I/II clinical trial evaluating the safety and early efficacy of its first-in-class altered energy metabolism-directed compound, CPI-613, in a variety of cancer types.
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The approved clinical trial will be open to patients with a variety of tumor types who have failed previous therapies. It will be conducted at a limited number of clinical trial sites in North America.
The CPI-613 trial is designed as an open label, dose-escalation study to evaluate safety, tolerability, maximum tolerated dose, efficacy, and pharmacokinetics of CPI-613 in multiple types of cancer patients.
Cornerstone has been granted orphan drug designation by the FDA for the use of CPI-613 in the treatment of pancreatic cancer.
Robert Shorr, CEO of Cornerstone, said: “We are optimistic that this approval will mark the next important step towards establishing these drugs as a safer, more effective way to treat a wide variety of cancer types, which could make a significant difference in the lives of cancer patients everywhere.”