CoFactor is Adventrx’s biomodulator designed to enhance the effects and reduce associated toxicity of the widely used cancer drug, 5-fluorouracil (5-FU). The company began dosing patients in the phase IIb trial in May 2005.
The clinical trial is a multi-center, 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. Adventrx plans to open an additional nine clinical sites for patient enrollment by the end of October.
“We are delighted by the rate of patient enrollment in this trial, which has so far exceeded our expectations,” said Evan Levine, president and CEO of Adventrx. “We believe this trial will further establish CoFactor’s favorable safety and efficacy profile in a direct comparison to leucovorin.”
Adventrx is also completing its US-based phase II CoFactor trial (COFU) in metastatic colorectal cancer and expects to report follow-up study data, including a third-party assessment of efficacy data, from this trial in the first quarter of 2006.
Additionally, the company is currently recruiting clinical sites for a US-based pivotal phase III trial in the same indication, and plans to begin dosing patients in the first quarter of 2006.