Pro-Pharmaceuticals Granted Pre-IND Meeting for Anti-Hypoxia Drug
06 August 2008 - 1:00PM
Business Wire
Pro-Pharmaceuticals, Inc. (AMEX: PRW), a bio-pharmaceutical company
developing proprietary polysaccharide-based therapeutic compounds
in the treatment of cancer and fibrosis, today announced that a
pre-Investigational New Drug (IND) meeting with the U.S. Food and
Drug Administration (�FDA�) is scheduled for October to present the
clinical development plan for a anti-hypoxia drug to be used in
combination with DAVANAT� and 5-FU to treat advanced solid tumors,
including head and neck, breast and colorectal cancers. The
proposed clinical plan is in direct response to current studies
indicating tumors resistance to chemotherapy and radiation are
linked to hypoxia. Hypoxia is a condition in which there is a
decrease in the oxygen supply to a tissue. Many tumors contain a
significant fraction of hypoxic cells, due to insufficient
vascularization. The reduction in oxygen within tumors confers
resistance to both radiotherapy and chemotherapy, and in many cases
correlates with a poor prognosis. �The human trials will evaluate
the ability of this unique combination to treat patients who failed
all standard anti-cancer therapies and their tumors are refractory
to further treatment,� said Dr. Hana Chen-Walden, Consulting
Medical Director, Pro-Pharmaceuticals. �This population represents
a significant number of cancer patients who do not have other
options.� About DAVANAT� DAVANAT� is a proprietary carbohydrate
drug that is administered with other drugs, including
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 therapeutic
compounds 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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