Adventrx Pharmaceuticals has reached an agreement under a special protocol assessment (SPA) with the FDA on the design of the company's CoFactor Phase III clinical trial protocol. CoFactor is a biomodulator drug designed to improve the efficacy and safety of the widely used chemotherapeutic agent, 5-fluorouracil (5-FU).
The clinical trial is a multicenter, 1200 patient, controlled study in the first-line therapy of patients with metastatic colorectal cancer. Patients will be equally randomized to treatment with either CoFactor or leucovorin, plus 5-FU and bevacizumab (Avastin). The primary endpoint in the study is progression-free survival. Secondary endpoints include response rate, overall survival and incidence and severity of adverse events.