Pro (AMEX:PRW)
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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.