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Pro-Pharmaceuticals Collaborates with Chemwerth to Scale-up Production of DAVANAT(R) for Initial Marketing Needs.


Chemwerth Scales-up DAVANAT([R]) to 100 Kilos per Batch

NEWTON, Mass. -- Pro-Pharmaceuticals, Inc. (Amex: PRW "Parents are watching." See digispeak. ), a developer of novel carbohydrate compounds, today announced it is collaborating with Chemwerth, Inc. to scale-up production of its lead drug candidate, DAVANAT([R]) to 100 kilograms for initial marketing needs. DAVANAT[R] is a carbohydrate polymer composed of mannose mannose /man·nose/ (man´os) a six-carbon sugar epimeric with glucose and occurring in oligosaccharides of many glycoproteins and glycolipids.

man·nose
n.
 and galactose (galactomannan). Chemwerth, Inc. is an Active Pharmaceutical Ingredient (API) development and supply company specializing in generic drugs that include oral, injectable in·ject·a·ble
adj.
Capable of being injected. Used of a drug.

n.
A drug or medicine that can be injected.
, topical and veterinary products.

"Our goal is to provide Pro-Pharmaceuticals with a clinical-grade quality product that meets the FDA's requirements for an NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any  submission," said Peter Werth Peter Werth is an upmarket clothing retailer located in the United Kingdom. The brand won FHM's 2002 Brand of the Year and has subsequently expanded into a womens collection, footwear and more. A flagship store has opened in The Met Quarter Liverpool in October. 2006. , Chief Executive Officer, Chemwerth, Inc. "We believe in Pro-Pharmaceuticals' DAVANAT([R]) product and look forward to helping them gain marketing approval."

"The ability to scale-up manufacturing of DAVANAT([R]) is an important step in the process to commercialize DAVANAT([R])," said Eliezer Zomer, Ph.D., Executive Vice President, Manufacturing & Product Development, Pro-Pharmaceuticals, Inc. "Chemwerth has been supplying the pharmaceutical industry with quality generic drugs for more than 20 years. To gain marketing approval for our lead compound DAVANAT([R]) would be a major milestone in the development of our technology."

Chemwerth offers one of the broadest lines of injectable grade oncology products in the U.S., including, Amifostine, Carboplatin USP USP - unique sales point , Cisplatin cisplatin /cis·plat·in/ (sis´plat-in) DDP; a platinum coordination complex capable of producing inter- and intrastrand DNA crosslinks; used as an antineoplastic.

cis·plat·in
n.
 USP, Doxorubicin doxorubicin /doxo·ru·bi·cin/ (dok?so-roo´bi-sin) an antineoplastic antibiotic, produced by Streptomyces peucetius, which binds to DNA and inhibits nucleic acid synthesis; used as the hydrochloride salt and as a liposome-encased  HCl USP, Epirubicin HCl EP, Etoposide USP, Fludarabine Phosphate, Gemcitabine HCl USP, Ifosfamide USP, Irinotecan HCl 3H2O, Mitoxantrone HCl USP/PhEur and Thiotepa thiotepa /thio·tepa/ (-tep´ah) a cytotoxic alkylating agent, used as an antineoplastic in the treatment of breast, ovarian, or bladder cancer, Hodgkin's disease, and malignant pleural or pericardial effusion.  USP.

The Company is using DAVANAT([R]) to obtain more timely and efficient marketing approval of new formulations of previously approved therapeutics which incorporate the Company's proprietary drug target delivery compound through Section 505(b)(2). The FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 has approved galactomannans for oral and topical applications. The Company is seeking approval for co-administration of DAVANAT([R]) (a galactomannan) with 5-Fluorouracil (5-FU) for intravenous injection in the treatment of cancer. FDA-approved, 5-FU is one of the world's most widely used chemotherapeutic drugs.

About DAVANAT([R])

DAVANAT([R]), the Company's lead drug candidate, is a polysaccharide polysaccharide: see carbohydrate.
polysaccharide

Any of a large class of long-chain sugars composed of monosaccharides. Because the chains may be unbranched or branched and the monosaccharides may be of one, two, or occasionally more kinds,
 (carbohydrate polymer) composed of mannose and galactose (galactomannan). The Company believes DAVANAT([R])'s mechanism of action is based upon binding to lectins Lectins

A class of proteins of nonimmune origin that bind carbohydrates reversibly and noncovalently without inducing any change in the carbohydrate. Lectins bind a variety of cells having cell-surface glycoproteins (carbohydrate bound proteins) or glycolipids
 on the cell surface. Lectins are carbohydrate-binding proteins found in increased amounts on cell surfaces. DAVANAT([R]), when injected into humans, recognizes and attaches to lectins. It is theorized that DAVANAT([R]) targets specific lectin lectin /lec·tin/ (lek´tin) any of a group of hemagglutinating proteins found primarily in plant seeds, which bind specifically to the branching sugar molecules of glycoproteins and glycolipids on the surface of cells.  receptors (Galectins) that are over-expressed on cancer cells. Current research indicates that Galectins affect cell development and play important roles in cancer, including tumor cell survival, angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization.

an·gi·o·gen·e·sis
n.
 and tumor metastasis metastasis /me·tas·ta·sis/ (me-tas´tah-sis) pl. metas´tases  
1. transfer of disease from one organ or part of the body to another not directly connected with it, due either to transfer of pathogenic microorganisms or to
. This form of targeted delivery may allow for higher doses of chemotherapy administration with no increase in toxicity.

Product Pipeline

DAVANAT([R]) is a powerful target delivery technology that may enhance the safety and efficacy profile of a variety of FDA-approved chemotherapy drugs. The Company continues to develop and expand its pipeline of drug candidates using DAVANAT([R]) and 5-FU in combination with other chemotherapeutics and biologics, such as irinotecan and AVASTIN([R]). The Company also is using its carbohydrate technology to develop novel liver anti-fibrosis drugs through a research collaboration with Mount Sinai School of Medicine
This page is about a medical school in New York. For other uses, please see: Mount Sinai (disambiguation)


Mount Sinai School of Medicine is a medical school found in the borough of Manhattan in New York City.
. The Company also is developing new chemical entities based on anti-fungal drugs and statin stat·in
n.
Any of a class of drugs that inhibit a key enzyme involved in the synthesis of cholesterol and promote receptor binding of LDL cholesterol, resulting in decreased levels of serum cholesterol.
 molecules.

Phase II Clinical Trials

The Company is conducting two Phase II clinical trials that are actively recruiting patients at 8 sites. The studies are evaluating DAVANAT([R]) with 5-FU in first line therapy in biliary and colorectal cancers. AVASTIN([R]) and Leucovorin are also being administered in treating colorectal patients. The company expects additional sites to become active shortly. Additional information on these clinical trials can be found at www.clinicaltrials.gov. Key word: DAVANAT([R]). The Company successfully completed a Phase I trial for end-stage cancer patients with all solid tumors and a Phase II trial for end-stage colorectal cancer patients.

About Chemworth, Inc.

Chemwerth is a full service Active Pharmaceutical Ingredient (API) development and supply company specializing in oral, injectable, topical and veterinary products at competitive prices. Founded in 1982 to supply the pharmaceutical industry with sources of reliable, high quality APIs, Chemwerth represents numerous FDA approved facilities in China, as well as current good manufacturing practices (cGMP) facilities in the United States, Europe and India. Additional information is available at www.chemwerth.com.

About Pro-Pharmaceuticals, Inc. - Advancing Drugs Through Glycoscience([R])

Pro-Pharmaceuticals is a development stage pharmaceutical company engaged in the discovery, development and commercialization of carbohydrate-based therapeutic compounds for advanced treatment of cancer, liver, microbial microbial

pertaining to or emanating from a microbe.


microbial digestion
the breakdown of organic material, especially feedstuffs, by microbial organisms.
, cardiovascular and inflammatory diseases. Initially, the product pipeline is principally focused on increasing the efficacy and decreasing the toxicity of approved chemotherapy drugs. The Company has been conducting clinical and pre-clinical studies with its lead compound, DAVANAT([R]), in combination with 5-FU, leucovorin, irinotecan, doxorubicin, oxaliplatin, paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia); , cisplatin, and bevacizumab (AVASTIN([R])). Results show that DAVANAT([R]) exhibits a broad spectrum of activity with tested drugs. The Company is developing other carbohydrate-based therapeutic compounds that are currently in the pre-clinical stage of development. Founded in 2000, 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 Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
" provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 as a result of various factors including, but not limited to, the following: uncertainties as to the utility and market for our potential products; uncertainties associated with pre-clinical and clinical trials of our product candidates; our limited experience in product development and expected dependence on potential licensees and collaborators for commercial manufacturing, sales, distribution and marketing of our potential products; possible development by competitors of competing products and technologies; lack of assurance regarding patent and other protection of our proprietary technology; compliance with and change of government regulation of our activities, facilities and personnel; uncertainties as to the extent of reimbursement for our potential products by government and private health insurers; our dependence on key personnel; our history of operating losses and accumulated deficit; and economic conditions related to the biotechnology and bio-pharmaceutical industry. We cannot assure you that we have identified all the factors that create uncertainties. Readers should not place undue reliance on forward-looking statements.

More information about those risks and uncertainties is contained and discussed in the "Management Discussion and Analysis of Financial Condition and Results of Operations" and "Risk Factors" sections of the Company's most recent quarterly or annual report and in the Company's other reports filed with the Securities and Exchange Commission. The forward-looking statements represent the Company's views as of the date of this news release and should not be relied upon to represent the Company's views as of a subsequent date. 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. CARBOSOME is a trademark of Pro-Pharmaceuticals. AVASTIN is a registered trademark of Genentech, Inc.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Feb 20, 2007
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