Cornerstone Pharmaceuticals has started a Phase I clinical trial of its lead drug candidate CPI-613, in combination with bendamustine (Treanda), to treat patients with relapsed or refractory classic Hodgkin’s lymphoma (HL) or T-cell non-Hodgkin’s lymphoma (NHL) who may or may not have received haematopoietic cell transplant.
CPI-613 is based on the company’s altered energy metabolism directed (AEMD) platform, which disrupts the essential bioenergetic differences that support the growth and development of many types of cancer cells.
HL and NHL are two common types of cancers of the lymphatic system, part of the immune system, that compromise the body’s ability to fight infections.
Classic Hodgkin’s lymphoma is the more common type of HL, with about 95% of cases considered to be classic HL.
The single site trial is sponsored by Wake Forest Baptist Medical Center in collaboration with the National Cancer Institute (NCI).
The open label, dose-escalating Phase I trial is designed to establish the maximum tolerated dose of CPI-613 when used in combination with bendamustine.
Response and overall survival rates will also be evaluated in this trial, which will include patients with relapsed or refractory classic HL or T-cell NHL who may or may not have received haematopoietic cell transplant.
The company said that bendamustine has shown single agent activity in the relapsed lymphoma setting with response rates of about 50% for B and T-cell NHL as well as in classic HL.
Cornerstone president and chief operating officer Robert Rodriguez said: "This clinical trial is a key milestone for Cornerstone, further demonstrating the potential applicability of our lead product candidate, CPI-613, in these types of haematologic malignancies, and the first study to examine the drug in the classic Hodgkin’s or T-cell non-Hodgkin’s lymphoma-specific patient population when combined with bendamustine.
"We look forward to working with the investigators at Wake Forest Baptist Medical Center on this study as we continue to explore the use of our AEMD approach in the treatment of a wide array of cancers."
Currently, CPI- 613 is being evaluated in Phase I, I/II and II human clinical trials in solid tumours and haematological malignancies.