US-based Cornerstone Pharmaceuticals has started 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).
The trial is designed to evaluate CPI-613, in combination with bendamustine and rituximab, in these 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.
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 haematologic 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 an 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."
Sponsored by Wake Forest Baptist Medical Center and 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.
The company said that secondary outcomes including response rate, overall survival rate, disease control rate and progression-free survival will also be evaluated in the trial.
In clinical trials, chemotherapy drug ‘bendamustine’ has shown single agent activity in heavily pretreated patients with rituximab-refractory (resistant), indolent NHL, showing an overall response rate of about 77%.
The company said that rituximab, an immunotherapy agent, was the first monoclonal antibody approved for cancer treatment.
Rituximab targets a specific antigen called CD-20 found on most B-cell lymphomasii and has been shown to result in a 40-50% response rate in patients who relapse with indolent B-cell lymphomas.