The trial is a multi-center 1,200-patient study in the first-line treatment of patients with metastatic colorectal cancer. Patients will be equally randomized to two arms containing either CoFactor or leucovorin, each in combination with 5-FU and bevacizumab, which is marketed by Roche and Genentech as Avastin.
The primary endpoint for the study is progression-free survival. Secondary endpoints include response rate, overall survival and incidence and severity of adverse events.
Patient eligibility screening for the pivotal trial has begun at several clinical sites. A total of 100 clinical sites in the US are planned for the phase III study, following institutional review board (IRB) approval of the clinical protocol, credentialing of the investigational team and an on-site inspection and procedural review by the company prior to drug shipment to the site pharmacy.
“The initiation of this phase III pivotal clinical trial for CoFactor in metastatic colorectal cancer represents an important milestone for our lead product development program and our business as a whole,” said Evan Levine, president and CEO of Adventrx. “We are very encouraged by the efficacy and safety data we have seen to date from the CoFactor phase II trial, which has surpassed most historical 5-fluorouracil plus leucovorin efficacy and safety results from multi-institutional studies.”