FDAnews
www.fdanews.com/articles/107787-adventrx-sees-mixed-results-for-cancer-study

Adventrx Sees Mixed Results for Cancer Study

June 17, 2008

Adventrx Pharmaceuticals provided an update regarding overall survival from its Phase IIb clinical trial of CoFactor for the treatment of first-line metastatic colorectal cancer. 

The trial was an international, open-label, randomized, controlled, multicenter study evaluating the safety and efficacy of treatment with CoFactor/5-FU compared with leucovorin/5-FU in 300 patients. The CoFactor arm demonstrated comparable overall safety to the leucovorin arm, the company said.

However, it did not demonstrate statistically significant improved safety in the trial’s primary endpoint, which was a reduction of patients reporting hematological or gastrointestinal adverse events of Grade 3 or higher.