First Stage of Adventrx CoFactor Meets Endpoints in Phase II Study

Adventrx Pharmaceuticals has announced that the primary endpoint for response rate and the secondary endpoint for safety were met in the first stage of its Simon two-stage design Phase II trial using CoFactor to modulate the effect of 5-fluorouracil (5-FU) in patients with metastatic colorectal cancer.

The company further announced that patient enrollment is complete in this Phase II study. The company currently expects to announce a complete summary of study results in the second quarter of this year.

The Phase II study, titled "COFU: A multicenter Phase II clinical trial to evaluate the safety and efficacy of weekly treatment with CoFactor and 5-fluorouracil in patients with metastatic colorectal carcinoma," is an open-label, single-arm study to evaluate safety, tumor response, time-to-tumor progression and overall survival in metastatic colorectal cancer patients treated with CoFactor and 5-FU. A total of 50 patients were recruited for this trial.