Adventrx Gets CoFactor Protocol Final Advice Letter From EMEA
Adventrx Pharmaceuticals has received a final advice letter from the European Medicines Agency (EMEA) for its proposed CoFactor trial protocol in pancreatic cancer.
Based on this information, the company plans to file a clinical trial application for a pivotal Phase III multinational study in patients with advanced pancreatic cancer in the second quarter of 2005 and will initiate the trial following regulatory clearance.
CoFactor is a biomodulator designed to enhance the activity of the widely used cancer drug 5-fluorouracil. The final advice letter was sent following a recent meeting between Adventrx and the EMEA in which the company sought assistance on the trial design protocol. Protocol assistance with the EMEA was provided without additional cost to the company under the Orphan Drug Act. CoFactor was granted orphan drug status for pancreatic cancer in both the European Union and U.S. in October of last year.