Adventrx Pharmaceuticals, Inc. has completed patient enrolment in a phase IIb clinical trial. The trial is designed to compare the safety and efficacy of 5-fluorouracil (5-FU) plus CoFactor to 5-FU plus leucovorin in first line treatment of metastatic colorectal cancer.

"We are pleased that we have completed enrolment in this 300 patient phase IIb trial, which began in the second quarter of 2005, and we currently expect to announce results in the second half of 2007, as originally planned," said James A. Merritt, MD, president and chief medical officer of Adventrx. "This trial is significant for us in that it will compare the safety and efficacy of CoFactor/5-FU with leucovorin/5-FU in an infusional setting, a common method of administration of 5-FU for treatment of metastatic colorectal cancer in Europe."

"We believe the phase IIb clinical study will reveal important information regarding the direct delivery of the active form of folate through the use of CoFactor," commented Evan M. Levine, Adventrx's CEO. "We continue to be enthusiastic about CoFactor's potential for enhancing the efficacy and safety of 5-FU chemotherapy in metastatic colorectal and other cancers, such as breast."

CoFactor is also being tested in a phase III pivotal trial in the US in combination with 5-FU and Avastin (bevacizumab).

CoFactor (ANX-510) is a folate-based biomodulator drug designed to replace leucovorin to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapy 5-fluorouracil (5-FU). In comparison to leucovorin, CoFactor creates more stable binding of the active form of 5-FU to the target enzyme, thymidylate synthase (TS). CoFactor bypasses the chemical pathway required by leucovorin to deliver the active form of folate, allowing 5-FU to work more effectively.