Adventrx begins phase 3 pivotal trial of CoFactor in metastatic colorectal cancer

By Lisa Kerner

Charlotte, N.C., June 28 - Adventrx Pharmaceuticals, Inc. said it began a randomized, controlled 1,200 patient phase 3 pivotal clinical trial to investigate the efficacy and safety of CoFactor in metastatic colorectal cancer.

Eligibility screening started at several clinical sites, with a total of 100 U.S. clinical sites planned.

Patients will be equally randomized to two arms containing either CoFactor or leucovorin, each in combination with 5-FU and bevacizumab (Avastin).

Progression-free survival is the primary endpoint of the study.

"The initiation of this phase 3 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," president and chief executive officer Evan M. Levine said in a company news release.

"We are very encouraged by the efficacy and safety data we have seen to date from the CoFactor phase 2 trial, which has surpassed most historical 5-fluorouracil plus leucovorin efficacy and safety results from multi-institutional studies."

Adventrx is a San Diego-based biopharmaceutical research and development company focused on treatments for cancer and infectious disease.

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