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news.Pro-Pharmaceuticals has received positive feedback from the US Food and Drug Adminstration regarding the design of a Phase III pivotal, randomized, controlled, and blinded trial of Davanat co-administered with standard chemotherapy for second line treatment of patients with metastatic colorectal cancer.
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Davanat is a polysaccharide polymer that targets Galectin receptors on cancer cells and interferes with their activity.
Pro-Pharma has fixed the primary endpoint of the trial as the increased survival with a secondary end point of reduced serious side effects of chemotherapy.
Pro-Pharma chief medical officer Peter Traber said that this successful meeting with the FDA clears the way for Pro-Pharmaceuticals to begin the Phase III development program following submission and approval of the final protocol.
Pro-Pharma CEO Theodore Zucconi said that they are encouraged by the findings of the previous clinical studies, which suggest that Davanat may be an effective anti-cancer agent that also reduces side effects.
"The positive feedback from the FDA meeting validates our strategy for approval in the US.
"This adds to our overall approach to commercialization of Davanat which includes expected approval in Colombia, South America in 2011, and the expanded application of Davanat in cancer vaccine, being developed in collaboration with the Ludwig Institute in Brussels. Blocking Galectins is a significant new tool in the fight against cancer.