Adventrx completes enrolment for breast cancer trial

The Phase II clinical trial is a single arm, multicenter study to evaluate the safety and efficacy of treatment with CoFactor plus 5-fluorouracil (5-FU) in advanced breast cancer patients who have failed anthracycline and taxane chemotherapies. Patients are treated with CoFactor followed by 5-FU administered by IV bolus weekly for six weeks, with tumor and safety assessments every eight weeks.

The primary endpoint for the study is objective response rate as defined by response evaluation criteria in solid tumors (RECIST) criteria, and secondary endpoints are duration of response, progression free survival, overall survival and incidence and severity of adverse events, as defined by the National Cancer Institute (NCI) common terminology criteria. A total of 32 patients were enrolled in this study.

CoFactor is a folate-based biomodulator drug designed to replace leucovorin as the preferred method to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-FU.

Evan Levine, CEO of Adventrx, said: “Data on the primary endpoint in this study, along with overall survival data from our Phase IIb study and available data from our discontinued Phase III study, all of which we expect in the second quarter of 2008, will expand our understanding of CoFactor’s safety and efficacy.”