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CombinatoRx'S Synavive (CRx-102) Maintains Efficacy Throughout 12 Month Phase 2 Knee OA Extension Trial.


-- Synavive-Naive Subjects Also Experienced Statistically Significant Benefits -

-- No Treatment-Related Increase in Glucocorticoid-Associated Adverse Events Observed --

CAMBRIDGE, Mass. -- CombinatoRx, Incorporated (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: CRXX) today announced the results of a 12 month knee osteoarthritis (OA) Phase 2 extension trial for Synavive([TM]) (CRx-102) at the American College of Rheumatology rheumatology /rheu·ma·tol·o·gy/ (-tol´ah-je) the branch of medicine dealing with rheumatic disorders, their causes, pathology, diagnosis, treatment, etc.

rheu·ma·tol·o·gy
n.
 (ACR See riser card. ) 2009 Annual Meeting in Philadelphia. The data demonstrated that Synavive-treated subjects maintained efficacy levels throughout the 12 month extension trial. These findings further support the core study data, which was presented at EULAR in June 2009, in which knee OA efficacy was observed early in treatment and sustained throughout the three month core study in all WOMAC WOMAC Western Ontario McMaster University Osteoarthritis Index Rheumatology An arthritic pain scoring system ranging from 0–no pain/disability to 100–most severe pain/disability  measurement subscales including pain, physical function and stiffness. Synavive is a novel dissociated dis·so·ci·ate  
v. dis·so·ci·at·ed, dis·so·ci·at·ing, dis·so·ci·ates

v.tr.
1. To remove from association; separate:
 glucocorticoid glucocorticoid /glu·co·cor·ti·coid/ (-kor´ti-koid)
1. any of the group of corticosteroids predominantly involved in carbohydrate metabolism, and also in fat and protein metabolism and many other activities (e.g.
 product candidate designed to enhance the anti-inflammatory benefits of glucocorticoids Glucocorticoids
Any of a group of hormones (like cortisone) that influence many body functions and are widely used in medicine, such as for treatment of rheumatoid arthritis inflammation.
, without associated side effects. Synavive contains the cardiovascular agent dipyridamole dipyridamole /di·py·rid·a·mole/ (di?pi-rid´ah-mol) a platelet inhibitor and coronary vasodilator used to prevent thromboembolism associated with mechanical heart valves, to treat transient ischemic attacks, and as an adjunct in  and a very low dose of the glucocorticoid prednisolone prednisolone /pred·nis·o·lone/ (pred-nis´ah-lon) a synthetic glucocorticoid derived from cortisol, used in the form of the base or the acetate, sodium phosphate, or tebutate ester in replacement therapy for adrenocortical insufficiency,  and is being developed as a uniquely engineered oral, once-daily formulation.

In addition to maintaining efficacy for the Synavive-treatment group, placebo-treated subjects in the core study also experienced statistically significant improvements in all WOMAC measurement subscales upon crossing over to Synavive in the extension trial. Importantly, no treatment-related increase in glucocorticoid associated adverse events were observed in Synavive-treated subjects.

"Synavive appears to be well-tolerated and efficacious in reducing the signs and symptoms of knee OA over a 3 to 12-month period," said Robert Forrester, Interim President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of CombinatoRx. "These findings support the knee OA core study results and supplement the positive hand OA core study data, providing an attractive risk/benefit ratio warranting further development of Synavive in inflammatory conditions such as osteoarthritis and rheumatoid arthritis".
[TABLE OMITTED]


About Synavive (CRx-102)

Synavive is a novel dissociated glucocorticoid product candidate designed to enhance the anti-inflammatory benefits of glucocorticoids, without associated side effects. Synavive contains the cardiovascular agent dipyridamole and a very low dose of the glucocorticoid prednisolone and is being developed as a uniquely engineered formulation. Synavive is thought to act through a novel multi-target mechanism of action in which dipyridamole synergistically syn·er·gis·tic  
adj.
1. Of or relating to synergy: a synergistic effect.

2. Producing or capable of producing synergy: synergistic drugs.

3.
 and selectively amplifies prednisolone's anti-inflammatory and immunomodulatory activities by inhibiting key cell mediators of inflammation. In prior proof-of-concept clinical trials, Synavive demonstrated a powerful anti-inflammatory effect and rapid onset of action onset of action Pharmacology The length of time needed for a medicine to become effective. See Therapeutic drug monitoring.  in patients with osteoarthritis and rheumatoid arthritis and was generally well-tolerated. Synavive is in Phase 2 clinical development for the treatment of immuno-inflammatory conditions.

About CombinatoRx

CombinatoRx, Incorporated (CRXX) is pioneering the new field of synergistic combination pharmaceuticals. Going beyond traditional combinations, CombinatoRx creates product candidates with novel mechanisms of action, striking at the biological complexities of human disease. The CombinatoRx proprietary drug discovery technology provides a renewable and previously untapped source of novel drug candidates. The Company was founded in 2000 and is located in Cambridge, Massachusetts. To learn more about CombinatoRx, please visit www.combinatorx.com.

Forward-Looking Statement:

This press release contains forward-looking statements within the meaning 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 concerning CombinatoRx and its Synavive product candidate. These forward-looking statements about future expectations, plans and prospects of CombinatoRx, and its Synavive product candidate involve significant risks, uncertainties and assumptions, including risks related to CombinatoRx's ability to further develop and obtain regulatory approval for the sale of Synavive and those other risks that can be found in the "Risk Factors" section of the CombinatoRx Annual Report on Form 10-K on file with the Securities and Exchange Commission and the other reports that CombinatoRx periodically files with the Securities and Exchange Commission. Actual results may differ materially from those CombinatoRx contemplated by these forward-looking statements. These forward looking statements reflect management's current views and CombinatoRx does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release.

(c) 2009 CombinatoRx, Incorporated. All rights reserved.
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Publication:Business Wire
Date:Oct 21, 2009
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