Pro-Pharmaceuticals announced that the FDA has agreed to the design of its Phase 3 trial of Davanat co-administered with standard chemotherapy for second line treatment of patients with metastatic colorectal cancer. The study will be a controlled and blinded trial whose primary end point will be increased survival with a secondary end point of reduced serious side effects of chemotherapy.
Davanat is a polysaccharide polymer that targets galectin receptors on cancer cells and interferes with their activity. Peer-reviewed studies have demonstrated that galectins affect cell development and play important roles in cancer, including tumor cell survival, angiogenesis, tumor metastasis and give the tumor the ability to evade the immune system.
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