Adventrx Initiates Patient Treatment in Metastatic Colorectal Cancer Trial

Adventrx Pharmaceuticals has initiated patient treatment in its international, 300-patient Phase IIb clinical trial to evaluate the safety and efficacy of the company's lead drug candidate, CoFactor, used in combination with 5-fluorouracil (5-FU) for the treatment of metastatic colorectal cancer.

The company also has received the necessary regulatory and ethics approvals from the individual countries' regulatory agencies to initiate the trial in the UK, Germany, Romania, Serbia and India. These individual country approvals are required in addition to clearance from the Medicines and Healthcare products Regulatory Agency (MHRA), which Adventrx received in April 2005. Applications to conduct this trial in Croatia and Poland are pending.

The approximate 300 patients in this multicenter, open-label, randomized, controlled study will be randomized to receive either CoFactor plus 5-FU, or leucovorin plus 5-FU. The primary endpoint for this trial is defined as reduction of Grade 3 or greater toxicity, as defined by the NCI Common Terminology Criteria for Adverse Events, Version 3, in the CoFactor/5-FU arm, compared with the leucovorin/5-FU control arm. Secondary endpoints in the trial are response rate, time to tumor progression and quality of life.