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Pro-Pharmaceuticals Has Requested a Pre-IND Meeting with the U.S. Food and Drug Administration

2008-07-15 06:00:00

Introduction of Oxygen-based Product (EZ-646) to the Company’s

Galactomannan-C (DAVANAT©)

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

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 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 companys

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.



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 Companys

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

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.

Pro-Pharmaceuticals, Inc.
Anthony D. Squeglia, 617-559-0033
[email protected]

Investor Relations Group
Investor Relations
Conrad F. Mir,

[email protected]

A. Berni
[email protected]

Laura Colontrelle
[email protected]

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