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news.Pro-Pharmaceuticals has received regulatory clearance to initiate a European phase III clinical trial for its drug Davanat, a second line treatment of patients with metastatic colorectal cancer.
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The study will evaluate the safety and efficacy of Davanat with 5-Fluorouracil (5-FU) in combination with irinotecan or oxaliplatin for second line treatment of patients with metastatic colorectal cancer. The primary endpoint is progression free survival. Secondary endpoints are response rate, time to progression, and quality of life.
The company is collaborating with a clinical research organization that is currently working with investigators and investigational review boards in France and Germany.
The trial will be conducted at clinical sites in the European Union and countries outside of the EU following regulatory and ethics approval in each country. The company expects to begin patient enrollment for this trial in the first quarter of 2006.
“We continue to be encouraged by our Davanat clinical program progress,” said Dr David Platt, CEO, Pro-Pharmaceuticals. “We are encouraged with the anti-tumor activity of Davanat /5-FU and look forward to confirming the benefit of this combination therapy in phase II/III trials for colorectal cancer and cholangiocarcinoma.”