Adventrx gets FDA clearance to start CoFactor phase 3 chemotherapy trial

By Elaine Rigoli

Tampa, Fla., May 22 - Adventrx Pharmaceuticals, Inc. has reached an agreement under a Special Protocol Assessment with the Food and Drug Administration on the design of the company's CoFactor phase 3 clinical trial protocol.

The company also announced it remains on track to start the trial in the second quarter of 2006.

CoFactor is a biomodulator drug designed to improve the efficacy and safety of the widely used chemotherapeutic agent, 5-fluorouracil, or 5-FU.

The phase 3 trial is a multi-center, 1,200 patient, controlled study in the first-line therapy of patients with metastatic colorectal cancer, the company said in a news release.

Patients will be equally randomized to treatment with either CoFactor or leucovorin, plus 5-FU and bevacizumab (Avastin), the release said.

The primary endpoint in the study is progression-free survival. Secondary endpoints include response rate, overall survival and incidence and severity of adverse events.

Adventrx is a biopharmaceutical research and development company located San Diego.

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