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Cornerstone starts Phase I study of CPI-613 as therapy of Hodgkin or T-cell non-Hodgkin lymphoma
22 October 2014 - 22 October 2014 - US developer of cancer metabolism-based therapeutics Cornerstone Pharmaceuticals Inc reported Tuesday the launch of a Phase I study of CPI-613, plus bendamustine (Treanda), in patients with relapsed or refractory classic Hodgkin lymphoma or T-cell non-Hodgkin lymphoma who may or may not have received hematopoietic cell transplant.

CPI-613 is Cornerstone's lead Altered Energy Metabolism Directed (AEMD) drug candidate - a first-in-class anticancer compound designed to disrupt the altered energy-production pathways in cancer cells by targeting mitochondrial metabolism.

The single site trial is a Phase I, open label, dose-escalating trial intended to determine the maximum tolerated dose of CPI-613 when used in combination with bendamustine. The trial, sponsored by Wake Forest Baptist Medical Center and in collaboration with the National Cancer Institute (NCI), will also measure response and overall survival rates.

Bendamustine has demonstrated single agent activity in the relapsed lymphoma setting with response rates of approximately 50 percent for B and T-cell NHL as well as in classic HL. The study will include patients with relapsed or refractory classic HL or T-cell NHL who may or may not have received hematopoietic cell transplant.

CPI- 613 is currently being evaluated in Phase I, I/II and II human studies in solid tumours and haematological malignancies.
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