The phase IIb clinical trial is a multi-center, randomized study to evaluate the safety and efficacy of infusional CoFactor and 5-FU versus infusional leucovorin and 5-FU in subjects with metastatic colorectal cancer. Currently there are approximately 250 patients enrolled in the clinical trial.
The interim safety and efficacy analysis was based on data from 150 patients, which represents half of the planned total enrollment of 300 patients. Since the data are masked, results from the analysis will not be made available to the company until the study is completed.
The data safety monitoring board (DSMB) is comprised of medical, surgical and statistical experts in colorectal cancer and in clinical trials who were selected by the company to serve as an independent monitoring board. The DSMB is responsible for monitoring patient safety in the phase IIb clinical trial and for conducting periodic analyses of trial safety and efficacy results.
“We are pleased to have received a positive recommendation from the DSMB which supports the continuation of this trial,” said James Merritt, chief medical advisor for Adventrx. “We are enthusiastic about comparing CoFactor against leucovorin as a 5-FU biomodulator in first line treatment of metastatic colorectal cancer.”