In the ongoing phase II colorectal cancer trial, patients with colon cancer, which has spread despite treatment with approved therapies, are receiving Davanat plus 5-fluorouracil in monthly cycles for at least two cycles or until their disease progresses. Dosing of patients began in May 2005. Further results of the investigation are expected in the second quarter of 2006.
Preliminary data shows that one patient had a significant response to the treatment, achieving at least a 50% reduction in total tumor size. Based on this preliminary data, the company expects to begin dosing patients in a Europe-based phase III trial for the second line treatment of colorectal cancer by the end of the second quarter of 2006.
The phase III study will enroll patients with metastatic colorectal cancer for second line treatment. This investigation will be a multi-center, randomized trial to evaluate the safety and efficacy of Davanat in combination with other therapies.