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news.Cornerstone Pharmaceuticals has commenced a Phase I clinical trial of its lead altered energy metabolism directed (AEMD) drug candidate, CPI-613, to treat patients with relapsed or refractory B-cell Non-Hodgkin lymphoma (NHL).
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The trial is designed to evaluate CPI-613, in combination with bendamustine and rituximab, in these NHL patients.
CPI-613 is a first-in-class anticancer compound designed to disrupt the altered energy-production pathways in cancer cells by targeting mitochondrial metabolism.
Sponsored by Wake Forest Baptist Medical Center in collaboration with the National Cancer Institute, the single site, open label, dose-escalating Phase I trial is designed to establish the maximum tolerated dose of CPI-613 when used in combination with bendamustine and rituximab.
Cornerstone chief executive officer Steve Carchedi said: "Initiating this Phase I trial marks the fourth ongoing trial evaluating our lead compound CPI-613 in advanced hematologic malignancies and overall the eighth study being sponsored by notable, National Cancer Institute-designated comprehensive cancer center, Wake Forest Baptist Medical Center.
"Furthermore, this study represents the continued interest in CPI-613 by the medical community as a unique approach to fighting cancer by blocking the energy producing pathways that support the growth and development of many cancer cells.
"We look forward to the active enrollment of B-cell Non-Hodgkin Lymphoma patients in this study as we seek to demonstrate the potential of our lead product candidate as part of a combination therapy."
According to the company, secondary outcomes including response rate, overall survival rate, disease control rate and progression-free survival will also be evaluated in the trial.