Pro-Pharmaceuticals, Inc. today announced that a pre-New Drug Application (“NDA”) meeting with the U.S. Food & Drug Administration (“FDA”) is scheduled for December 22nd for DAVANAT® under Section 505 (b)(2) to be co-administered with 5-Fluorouracil (5-FU) to treat late-stage colorectal cancer patients.
“Our goal is to commercialize DAVANAT® and to generate revenue in 2009,” said Theodore Zucconi, Ph.D., President, Pro-Pharmaceuticals, Inc. “In pre-clinical and clinical studies, DAVANAT® has improved efficacy and reduced toxicity of chemotherapies and biologics. We also are working on potential licensing agreements and have regional agreements in place to market DAVANAT® internationally.”
The Company is using DAVANAT®, a galactomannan, to obtain more timely and efficient marketing approval of new formulations of previously approved therapeutics which incorporate the Company’s proprietary drug through Section 505 (b)(2). The FDA has approved galactomannans for other uses, such as oral or topical delivery. The Company is seeking approval for co-administration of DAVANAT® (a galactomannan) with 5-FU for intravenous injection for the treatment of advanced colorectal cancer.
About DAVANAT® DAVANAT®, a new chemical entity, is a proprietary carbohydrate compound that is administered with chemotherapies and biologics to treat cancer. DAVANAT®'s mechanism of action is based on binding to lectins. DAVANAT® targets specific lectin receptors (Galectins) on cancer cells. Current research indicates that Galectins affect cell development and play important roles in cancer, including tumor cell survival, angiogenesis and tumor metastasis.
Pro-Pharmaceuticals, Inc. – Advancing Drugs Through Glycoscience®
Pro-Pharmaceuticals is engaged in the discovery, development, and commercialization of carbohydrate-based, targeted therapeutics for advanced treatment of cancer, liver, microbial, and inflammatory diseases. Initially, the product pipeline is focused on developing targeted therapeutics to treat cancer. The Company’s technology also is being developed to explore the treatment of liver and kidney fibrosis. The Company is headquartered in Newton, Mass.
Contact:
Pro-Pharmaceuticals, Inc.
Anthony D. Squeglia, 617-559-0033
squeglia@pro-pharmaceuticals.com
Source: Pro-Pharmaceuticals, Inc.
“Our goal is to commercialize DAVANAT® and to generate revenue in 2009,” said Theodore Zucconi, Ph.D., President, Pro-Pharmaceuticals, Inc. “In pre-clinical and clinical studies, DAVANAT® has improved efficacy and reduced toxicity of chemotherapies and biologics. We also are working on potential licensing agreements and have regional agreements in place to market DAVANAT® internationally.”
The Company is using DAVANAT®, a galactomannan, to obtain more timely and efficient marketing approval of new formulations of previously approved therapeutics which incorporate the Company’s proprietary drug through Section 505 (b)(2). The FDA has approved galactomannans for other uses, such as oral or topical delivery. The Company is seeking approval for co-administration of DAVANAT® (a galactomannan) with 5-FU for intravenous injection for the treatment of advanced colorectal cancer.
About DAVANAT® DAVANAT®, a new chemical entity, is a proprietary carbohydrate compound that is administered with chemotherapies and biologics to treat cancer. DAVANAT®'s mechanism of action is based on binding to lectins. DAVANAT® targets specific lectin receptors (Galectins) on cancer cells. Current research indicates that Galectins affect cell development and play important roles in cancer, including tumor cell survival, angiogenesis and tumor metastasis.
Pro-Pharmaceuticals, Inc. – Advancing Drugs Through Glycoscience®
Pro-Pharmaceuticals is engaged in the discovery, development, and commercialization of carbohydrate-based, targeted therapeutics for advanced treatment of cancer, liver, microbial, and inflammatory diseases. Initially, the product pipeline is focused on developing targeted therapeutics to treat cancer. The Company’s technology also is being developed to explore the treatment of liver and kidney fibrosis. The Company is headquartered in Newton, Mass.
Contact:
Pro-Pharmaceuticals, Inc.
Anthony D. Squeglia, 617-559-0033
squeglia@pro-pharmaceuticals.com
Source: Pro-Pharmaceuticals, Inc.
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