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www.fdanews.com/articles/81535-adventrx-reports-patient-enrollment-progress-in-cofactor-trial

ADVENTRX REPORTS PATIENT ENROLLMENT PROGRESS IN COFACTOR TRIAL

October 10, 2005

Adventrx Pharmaceuticals announced that it has completed approximately 25 percent of the planned enrollment in its European Union-based CoFactor Phase IIb clinical trial for the treatment of metastatic colorectal cancer. The company began dosing patients in this trial in May. CoFactor is a biomodulator designed to enhance the effects and reduce associated toxicity of the widely used cancer drug, 5-fluorouracil (5-FU).

The Phase IIb clinical trial is a multicenter, open-label, randomized study to evaluate the safety and efficacy of CoFactor and 5-FU versus leucovorin and 5-FU in first-line treatment for metastatic colorectal cancer. Approximately 300 patients in this study will be randomized to receive either CoFactor plus 5-FU or leucovorin plus 5-FU. To date, 21 clinical sites have been opened for patient enrollment in the UK, India, Serbia, Poland and Romania. The company plans to open an additional nine clinical sites for patient enrollment by the end of October.