Adventrx Pharmaceuticals, Inc. has received clearance from the US FDA under a Special Protocol Assessment (SPA) to initiate a Phase III pivotal clinical trial with CoFactor for the treatment of metastatic colorectal cancer. CoFactor is the Company's biomodulator designed to enhance the activity of the widely used cancer drug 5-fluorouracil (5-FU).
The US Phase III pivotal clinical trial will be a randomized, open label multi-centre, parallel group, study of CoFactor as a first-line, combination therapy in patients with metastatic colorectal carcinoma. The two-arm study is expected to include approximately 600 patients, half of whom will be treated with CoFactor, 5-FU and bevacizumab (Avastin), compared with the other half of the patient population who will be treated with leucovorin, 5-FU and bevacizumab (Avastin). The primary end-point for this study is progression free survival (PFS), defined as the time from start of treatment to time of disease progression or death.
Adventrx recently received clearance in the UK to begin an international Phase IIb trial with CoFactor in metastatic colorectal cancer and plans to file in the first half of this year for clearance to initiate a EU-based Phase III CoFactor study in pancreatic cancer. Results from the Company's ongoing Phase II clinical trial using CoFactor and 5-FU for metastatic colorectal cancer are expected to be announced in Q2 2005, the release said.