Pro-Pharmaceuticals Has Requested a Pre-IND Meeting with the U.S. Food and Drug Administration
15 Juli 2008 - 1:00PM
Business Wire
Pro-Pharmaceuticals, Inc. (AMEX: PRW), a biopharmaceutical company
developing proprietary polysaccharide-based therapeutic compounds
in the treatment of cancer and fibrosis, has requested a
pre-Investigational New Drug (IND) meeting with the U.S. Food and
Drug Administration (�FDA�) to define the regimen for an
Oxygen-based product (EZ-646) to be used with Galactomannan-C
(DAVANAT�) and Fluorouracil (5-FU) to treat all solid tumors,
including new indications such as head & neck and breast
cancers. The proposed meeting agenda is in direct response to
current promising studies regarding the relationship between solid
tumor attenuation and hypoxia. Hypoxia is a condition in which
there is a decrease in the oxygen supply to a tissue. In cancer
treatment, the level of hypoxia in a tumor may help predict the
response of the tumor to the treatment. Many human tumors contain a
significant fraction of hypoxic cells, due to uncontrolled cell
growth and insufficient vascularization. Oxygen measurements of
several cancer types show a range of oxygen in the tumor tissues,
which is significantly lower than the adjacent normal tissues. The
reduction in oxygen within tumors confers resistance to both
radiotherapy and chemotherapy, and in many cases correlates with a
poor prognosis. On May 16, 2008, the company submitted a drug
master file application (Type II DMF No. 21629) as an important
step in its planned New Drug Application (NDA) filing to the FDA
for the company�s lead drug candidate, DAVANAT�. Based on the
completion of final reports of Phase I and Phase II clinical trials
(IND serials 0032 and 0051, September 22, 2006 and February 2,
2008, respectively) for all solid tumors and colorectal cancer,
published research, safety data, and new in vitro studies, the
company finds the results compelling and is exploring the promise
of this new combination therapy in addition to DAVANAT� with 5-FU.
�Oxygen therapy has been explored over the years but the underlying
implications are very exciting,� said Eliezer Zomer, Ph.D.,
Executive Vice President Product Development & Manufacturing.
�The current published data lends itself to what we believe to be
evolutionary in the field of solid tumor reduction.� David Platt,
Ph.D., Chairman and CEO of Pro-Pharmaceuticals, commented, �We
strongly believe the addition of EZ-646 can help increase efficacy.
There is much data supporting this move and we believe the FDA will
encourage our efforts.� About DAVANAT� DAVANAT� is a proprietary
carbohydrate polymer 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 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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