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news.Adventrx Pharmaceuticals has reported that it has met the primary endpoint in its phase II clinical trial evaluating the safety and efficacy of CoFactor and 5-fluorouracil in patients with metastatic colorectal cancer.
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The two-stage design phase II CoFactor clinical trial included patients with surgically incurable, metastatic colon or rectal adenocarcinoma. CoFactor is a biomodulator developed to enhance the activity of the widely used cancer drug 5-fluorouracil (5-FU).
Response rate, the trial’s primary endpoint, was defined in this trial as the tumor shrinking at least 50%, based on World Health Organization criteria, or complete response following treatment as measured by CT or MRI scans. Other endpoints being evaluated were safety, time-to-tumor-progression and overall survival.
“We are exceptionally pleased to see continued positive results in patients treated with CoFactor in combination with 5-FU in this phase II trial as we prepare to initiate three additional clinical trials with CoFactor this year,” said Evan Levine, Adventrx president and CEO.
Adventrx has filed clinical trial applications in the EU, including the UK and Germany, and in countries outside the EU for clearance to evaluate CoFactor in a phase IIb trial for metastatic colorectal cancer. The company also plans to file in the first half of 2005 for clearance with the FDA to launch a phase III randomized controlled trial in metastatic colorectal cancer.