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news.Adventrx Pharmaceuticals' shares have risen over 5% after it achieved positive results in the first stage of a phase II cancer study, meeting its primary endpoint for response rate and secondary endpoint for safety.
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Both endpoints were met in the first stage of Adventrx’ two-stage design phase II trial using CoFactor to modulate the effect of 5-fluorouracil (5-FU) in patients with metastatic colorectal cancer. The company further announced that patient enrollment is complete in this phase II study.
The phase II study is an open-label, single-arm study to evaluate safety, tumor response, time-to-tumor progression and overall survival in metastatic colorectal cancer patients treated with CoFactor and 5-FU. A total of 50 patients were recruited for this trial.
“We are pleased with our clinical progress and we currently plan to report summary clinical results from the entire phase II trial this spring,” said Dr Cellia Habita, Adventrx’ senior vice president of clinical and medical affairs.
“We initiated this trial on the strength of earlier phase I/II results that demonstrated CoFactor administered with 5-FU appeared to show improvement of objective response and time-to-tumor progression and reduced toxic side effects in colorectal, pancreatic, gastric and breast cancers.”
The company is currently in the process of applying for additional clinical studies with CoFactor in combination with other regimens in metastatic colorectal, advanced pancreatic, and late stage gastric cancers, and aims to file an new drug application (NDA) in 2007.