ADVENTRX Pharmaceuticals has reported disappointing results for its Phase IIb trial of CoFactor, a treatment for metastatic colorectal cancer. CoFactor/5-FU did not demonstrate statistically significant improved safety in the trial's primary endpoint--a reduction in the proportion of patients reporting at least one hematological or gastrointestinal adverse event of grade 3 or greater.
"The results of this trial are disappointing in that we were unable to demonstrate better safety with CoFactor plus 5-FU versus leucovorin plus 5-FU in the infusional setting," stated Evan M. Levine, chief executive of ADVENTRX. "We will carefully analyze the full set of data and our assumptions underlying the development of CoFactor for the treatment of metastatic colorectal cancer in determining the future of this program."
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