Pro-Pharmaceuticals' Pre-NDA Meeting Scheduled with FDA
October 06 2008 - 6:00AM
Business Wire
Pro-Pharmaceuticals, Inc. (Amex: PRW) 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. Additional information is available
at www.pro-pharmaceuticals.com. FORWARD LOOKING STATEMENTS: Any
statements in this news release about future expectations, plans
and prospects for the Company, including without limitation,
statements containing the words believes, anticipates, plans,
expects, and similar expressions, constitute forward-looking
statements as defined in the "safe harbor" provisions of the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements are based on management's current
expectations and are subject to a number of factors and
uncertainties, which could cause actual results to differ
materially from those, described in such statements. We caution
investors that actual results or business conditions may differ
materially from those projected or suggested in forward-looking
statements. More information about those risks and uncertainties is
contained in the Company's most recent quarterly or annual report
and other reports filed with the Securities and Exchange
Commission. While the Company anticipates that subsequent events
may cause the Company's views to change, the Company disclaims any
obligation to update such forward-looking statements. DAVANAT and
Advancing Drugs Through Glycoscience are registered trademarks of
Pro-Pharmaceuticals.
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