Pro-Pharmaceuticals, Inc., the leading developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced that on December 17, 2010, Company representatives met with officials from the U.S. Food & Drug Administration (FDA) to present its Phase III clinical development program for DAVANAT®. Agreement was reached on the design of a pivotal, randomized, controlled, and blinded Phase III clinical trial of DAVANAT® co-administered with standard chemotherapy for second line treatment of patients with metastatic colorectal cancer. The primary end point for the trial will be increased survival with a secondary end point of reduced serious side effects of chemotherapy.
“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”
"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," said Peter G. Traber, M.D., Chief Medical Officer, Pro-Pharmaceuticals. "Extending patient survival, while decreasing severe adverse effects of chemotherapy, is significant and unique. The successful meeting with the FDA is an essential step in the DAVANAT® development program and we look forward to implementing it in 2011."
"The Phase III development program is an important milestone towards achieving our goal of commercializing DAVANAT®, an innovative approach to treating cancer patients," said Theodore Zucconi, Ph.D., Chief Executive Officer, Pro-Pharmaceuticals. "We are highly encouraged by the findings of our previous clinical studies, which suggest that DAVANAT® may be an effective anti-cancer agent that also reduces side effects. We are optimistic that our novel Galectin-targeting compound may improve treatment for metastatic colorectal cancer.
"The positive feedback from the FDA meeting validates our strategy for approval in the U.S. 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," Zucconi said.
Results to date show that the Company's Galectin-targeting compounds also have reversed liver fibrosis in animal models, demonstrating that Galectins are involved in multiple diseases. The ability to block Galectins is a potential therapy even for diseases that have no present effective therapy, such as fibrosis/cirrhosis of the liver. The Company is developing its GM and GR Series of compounds for treating liver fibrosis/cirrhosis by collaborating with Dr. Scott Friedman at the Mount Sinai School of Medicine, a world leader in liver research.