CombinatoRx Publishes Clinical Study Results of CRx-102 in Hand Osteoarthritis.Results Published in Annals of Rheumatic Diseases Finds CRx-102 Effective at Reducing Pain in Hand OA 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 that Annals of the Rheumatic Diseases has published the results of its CRx-102 Phase 2a hand osteoarthritis osteoarthritis or osteoarthrosis or degenerative joint disease Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first. trial. The manuscript entitled "Efficacy and Safety of a Novel Synergistic Drug Candidate - CRx-102 - in Hand Osteoarthritis", Kvien, et.al. was pre-published on-line (http://ard.bmj.com/onlinefirst.dtl) and will run in an upcoming print edition. Annals of Rheumatic Diseases is the peer reviewed European League Against Rheumatism rheumatism (r `mətĭzəm), general term for a number of disorders that cause inflammation and pain in muscles, bones, joints, or nerves. (EULAR) journal for
rheumatic disease health professionals and researchers.
"This study demonstrated that the synergistic combination drug candidate, CRx-102, is effective at reducing pain in hand osteoarthritis, and warrants further clinical investigation," commented Tore K. Kvien, MD, Professor 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. , Diakonhjemmet Hospital, Oslo, Norway, and principal investigator of the study. "Based on the encouraging data summarized in Dr, Kvien's article, we have recently initiated a Phase 2b trial, COMET-1 (CRx-102 Osteoarthritis Multi-center Evaluation Trial), to evaluate the efficacy of CRx-102 in subjects with symptomatic knee osteoarthritis. The COMET-1 trial will further examine the role CRx-102 could play in filling the gap in treatment options for patients with osteoarthritis," added Daniel Grau, Chief Operating Officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. of CombinatoRx. CRx-102 will also be tested in rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. in the Phase 2b MARS-1 study (Multi-center Active RA Study), set to initiate in the 4th quarter of 2007. About CRx-102 CRx-102 is an oral synergistic combination drug candidate with a novel multi-target mechanism that inhibits key cell mediators of inflammation. CRx-102 combines 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 an unconventionally low dose of the glucocorticosteroid 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, . CRx-102 works through a novel mechanism of action in which dipyridamole selectively amplifies prednisolone's anti-inflammatory and immunomodulatory activities without replicating its side effects Side effects Effects of a proposed project on other parts of the firm. . In Phase 2 clinical trials, CRx-102 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. CRx-102 is being developed in a modified-release commercial formulation to provide enhanced clinical benefit across multiple immuno-inflammatory diseases. CRx-102 is currently in Phase 2b development as an alternative to standard of care anti-inflammatory and pain therapies for the treatment of rheumatoid arthritis and osteoarthritis. To date, CRx-102 has demonstrated positive results in three placebo-controlled Phase 2 clinical trials. In a previous study of hand osteoarthritis, CRx-102 demonstrated a statistically significant reduction in pain and stiffness (31% vs. 7%) as well as improvements in tender and swollen joints. In a rheumatoid arthritis trial, CRx-102 demonstrated statistically significant improvements in ACR See riser card. 20 (63% vs. 30%) and DAS28 scores (-1.6 vs. -0.7). The anti-inflammatory effect of CRx-102 was further demonstrated in an inflammatory biomarker study, in which subjects treated with CRx-102 experienced a statistically significant reduction in C-reactive protein compared with placebo (-0.65mg/L vs. 0mg/L). About Osteoarthritis Osteoarthritis is the most common degenerative joint disease degenerative joint disease n. Abbr. DJD See osteoarthritis. degenerative joint disease Osteoarthritis, see there and a frequent cause of physical disability among older adults. According to the Arthritis Foundation, more than 21 million people in the United States suffer from the disease. Osteoarthritis affects the hands, lower back, neck, and weight-bearing joints such as the knees, hips, and feet. Symptoms of osteoarthritis range from stiffness and intermittent mild pain to severe joint pain and impaired biomechanical function. There is no cure for most forms of osteoarthritis. Currently available therapies that are designed to help patients manage symptoms include analgesics Analgesics Definition Analgesics are medicines that relieve pain. Purpose Analgesics are those drugs that mainly provide pain relief. , anti-inflammatory drugs such as non-steroidal anti-inflammatory drugs Non-steroidal anti-inflammatory drugs (NSAIDs) Aspirin, ibuprofen, naproxen, and many others. Mentioned in: Mastocytosis (NSAIDs) and COX-2 inhibitors, opioids such as morphine, intra-articular corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and injection and surgery. About CombinatoRx CombinatoRx, Incorporated (CRXX) is pioneering the new field of synergistic combination pharmaceuticals and has a broad product portfolio in phase 2 clinical development. Going beyond traditional combinations, CombinatoRx creates product candidates with novel mechanisms of action striking at the biological complexities of human disease. The lead programs in the CombinatoRx portfolio are advancing into later stage clinical trials based on the strength of multiple positive Phase 2a results. This portfolio is internally generated from the CombinatoRx proprietary drug discovery technology which 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, its product candidate CRx-102, its clinical, commercial and therapeutic potential, its plans for clinical and formulation development of CRx-102, its business plans and its drug discovery technology. These forward-looking statements about future expectations, plans and prospects of CombinatoRx and CRx-102 involve significant risks, uncertainties and assumptions, including risks related to the Company's ability to enroll and successfully complete its clinical trials of CRx-102, the Company's ability to develop a proprietary formulation of CRx-102, potential difficulty and delays in obtaining regulatory approval for the sale and marketing of CRx-102, the unproven nature of the CombinatoRx drug discovery technology, the Company's ability to obtain additional financing or funding for its research and development 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. 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) 2007 CombinatoRx, Incorporated. All rights reserved. |
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