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news.Cornerstone Pharmaceuticals, a privately held pharmaceutical company, has started dosing patients in a recently approved safety and early efficacy clinical trial of CPI-613, its first-in-class altered energy metabolism-directed compound being evaluated for potential use in a wide array of cancers.
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Health Canada and the FDA have approved the initiation of studies of CPI-613, which will be conducted at clinical trial sites in both the US and Canada.
The approved trial is designed to be an open label, dose-escalation study to evaluate safety, tolerability, maximum tolerated dose, efficacy, and pharmacokinetics of CPI-613 in multiple types of cancer.
CPI-613 and related compounds are well tolerated in several different animal tumor models at doses that significantly exceed the effective anti-tumor doses in these models. These findings, among others, led to the decision to seek regulatory approval to begin clinical trials, the company said.
Robert Rodriguez, president and chief operating officer of Cornerstone, said: “The recent regulatory approvals and commencement of this clinical trial in both the US and Canada represent significant milestones in the global development of the company’s altered energy metabolism-directed compound platform.
“Given the novelty of the proposed mechanism of action and the highly encouraging preclinical efficacy and safety data, we look forward to advancing the development of this promising class of agents to therapeutic fruition for patients suffering from many types of cancer.”