Adventrx completes enrollment in CoFactor colorectal cancer trial

By E. Janene Geiss

Philadelphia, Sept. 25 - Adventrx Pharmaceuticals, Inc. said Monday that it has completed patient enrollment in a phase 2b clinical trial 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.

The trial is a 300-patient study that began in the second quarter of 2005, the San Diego biopharmaceutical company said in a news release. The company said it expects to announce results in the second half of 2007.

The trial is designed to compare the safety and efficacy of CoFactor plus 5-FU to leucovorin plus 5-FU in first line treatment of patients with metastatic colorectal carcinoma. The primary endpoint is reduction of grade 3 or greater toxicity in the CoFactor/5-FU arm over the leucovorin/5-FU arm. Secondary endpoints are response rate, time to progression and quality of life.

The company said CoFactor also is being tested in a phase 3 pivotal trial in the United States in combination with 5-FU and Avastin (bevacizumab).

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