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news.Adventrx Pharmaceuticals has begun treating patients as part of an international phase II trial to evaluate the safety and efficacy of CoFactor, in combination with 5-fluorouracil, for the treatment of metastatic colorectal cancer.
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Adventrx has also received the necessary regulatory and ethical approvals to begin trialing the drug, its lead drug candidate, in the UK, Germany, Romania, Serbia and India. Applications to conduct trials in Croatia and Poland are pending.
Approximately 300 patients will be recruited in this multi-center phase II study. Participants will be randomized to receive either CoFactor in combination with 5-fluorouracil (5-FU), or leucovorin and 5-FU. Adventrx hopes the results will show a reduction of toxicity in the CoFactor/5-FU participants, compared with the control group. The trial will also measure response rate, time to tumor progression and quality of life.
Adventrx has also been given the go-ahead to begin a phase III pivotal study of CoFactor in the same patient population. The company plans to file this year for clearance to initiate a European Union-based phase III CoFactor study in pancreatic cancer.
“Based on the strength of earlier studies in which CoFactor has demonstrated enhanced antitumor activity with significantly lower associated systemic toxicity in colorectal cancer compared with historic leucovorin and 5-FU-based treatment regimens, we are moving into this phase II trial as the next important step toward gaining market approval,” said Evan Levine, president and CEO of Adventrx.