ADVENTRX INITIATES PHASE II BREAST CANCER STUDY

Adventrx Pharmaceuticals has begun a Phase II clinical trial using CoFactor in the treatment of refractory metastatic breast cancer. CoFactor (ANX-510) is a folate-based biomodulator drug designed to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-fluorouracil (5-FU).

This study builds on the results of earlier studies and will more fully investigate the efficacy and safety of CoFactor for patients with previously treated, advanced breast cancer.

The trial is a single-arm, multicenter study to evaluate the safety and efficacy of treatment with CoFactor plus 5-FU in advanced breast cancer patients who have failed anthracycline and taxane chemotherapies. Patients will be treated with CoFactor followed by 5-FU administered by intravenous bolus weekly for six weeks, with tumor and safety assessments every eight weeks. The primary endpoint for the study is objective response rate, and secondary endpoints are duration of response, progression-free survival, overall survival and incidence and severity of adverse events. A total of 31 patients are expected to be enrolled at six clinical sites.

Compared with leucovorin, CoFactor creates more stable binding of the active form of 5-FU to the target enzyme, thymidylate synthase, according to the company. CoFactor bypasses the chemical pathway required by leucovorin to deliver the active form of folate, allowing 5-FU to work more effectively. In addition to the Phase II breast cancer trial, CoFactor is being studied in first-line treatment of metastatic colorectal cancer in a Phase IIb and pivotal Phase III clinical trial.