Introduction of Oxygen-based Product (EZ-646) to the Company’s
with 5-FU to Treat All Solid Tumors, especially Head & Neck, Breast &
This Study is in Addition to the Company’s
Ongoing Phase II Clinical Trials of DAVANAT©
with 5-FU to Treat Colorectal & Biliary Cancer
NEWTON, Mass.–(EMWNews)–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
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 hypoxiccells, due to uncontrolled cell growth and insufficient
vascularization. Oxygen measurements of several cancer typesshow a range of oxygenin the tumor
tissues, which is significantly lower thanthe
adjacent normal tissues. The reduction in oxygenwithin
tumors confers resistance to both radiotherapyand
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®
“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.”
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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