CombinatoRx Drug Candidate CRx-102 Demonstrates Statistically Significant Improvement in Pain and Other Clinical Measures.CAMBRIDGE, Mass. -- --New Data Presented on Stiffness, Physical Function, Joint Pain and Patient Global Assessment Scores -- 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 additional results of its randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , blinded, placebo-controlled Phase 2 clinical trial phase 2 clinical trial Phase 2 study. See Phase study. of CRx-102 in patients with 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. of the hand. In a poster presented on June 22, 2006 by Tore Kvien, MD at the 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) Annual Congress 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. Meeting in Amsterdam, The Netherlands, entitled "Efficacy and Safety of a Novel Syncretic syn·cre·tism n. 1. Reconciliation or fusion of differing systems of belief, as in philosophy or religion, especially when success is partial or the result is heterogeneous. 2. Drug Candidate - CRx-102 - in Hand Osteoarthritis" (Abstract THUO396), CRx102 demonstrated a statistically significant mean improvement in pain relief, the primary endpoint of the study, as well as improvements in additional clinical measures including stiffness, physical function, joint pain and patient global assessment scores.
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Clinical CRx-102 Placebo CRx-102 CRx-102 CRx-102
Measure Mean Mean P Value Mean Improvement
Improvement Improvement Baseline from
Baseline(3)
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Pain(1) 102.4mm 31mm 0.006(2) 309.3mm 33%
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Stiffness 20.3mm 8.3mm 0.023(2) 62.9mm 32%
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Physical
Function 115.8mm 53.1mm 0.081 584.2mm 20%
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Joint Pain 23.5mm 6.3mm 0.002(2) 59.8mm 39%
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Patient
Global 23.4mm 4.6mm <0.001(2) 61.5mm 38%
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Notes: (1)Primary endpoint (2)Statistically significant
(3)Calculation (mean improvement/ mean baseline x 100)
CRx-102 was well tolerated with no serious adverse events reported in patients treated in this study. Headache and nausea were the only adverse events that occurred at a frequency of greater than 5%, and both are known side effects Side effects Effects of a proposed project on other parts of the firm. of 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 . There were no increases in infection or blood glucose levels observed in the CRx-102 treated population as compared to placebo. "In this six week study, CRx-102 demonstrated efficacy in reducing pain in hand osteoarthritis," commented Tore K. Kvien, MD, Professor of Rheumatology, Diakonhjemmet Hospital, Oslo Norway, and principal investigator of the study. "Importantly, indicators of joint involvement, including tenderness and soft tissue swelling were also improved in this study, further demonstrating that additional studies are warranted to examine whether CRx-102 can fill the gap in available treatments for patients with osteoarthritis." "These data clearly show that CRx-102 is broadly clinically active in osteoarthritis as measured by an overall mean improvement in joint pain, not just finger joints, and as measured by patient global assessment score improvements, where patients are asked to evaluate their osteoarthritis taking all symptoms into consideration," commented Dr. Jan Lessem, Chief Medical Officer of CombinatoRx, Incorporated. "Based on this compelling data with CRx-102, we are eager to begin further clinical studies in both hand osteoarthritis and a broader osteoarthritis patient population," said Alexis Borisy, 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. "It is especially encouraging to see the successful translation of the CombinatoRx technology and discovery approach, from screen to animal and now confirmed through positive human clinical studies." About CRx-102 CRx-102 is a novel orally available syncretic drug candidate in Phase 2 clinical development for immuno-inflammatory diseases. A syncretic drug comprises two compounds that are designed to act 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. through multiple pathways to provide a novel therapeutic effect which neither component alone can achieve. CRx-102 contains a low dose of the steroid 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, with dipyridamole. The target product profile for CRx-102 is to selectively amplify certain elements of prednisolone's anti-inflammatory and immunomodulatory activities, without replicating steroid side effects. CRx-102 is a novel synergistic combination drug candidate discovered using the CombinatoRx combination High Throughput Screening (cHTS(TM)) technology. We plan to develop CRx-102 in a unique formulation for the treatment of a broad range of immuno-inflammatory conditions. To date, CRx-102 has been studied in two Phase 2 clinical trials, including patients with osteoarthritis of the hand in which CRx-102 demonstrated a statistically significant effect in pain relief, as well as improvements in stiffness, physical function, joint pain and patient global scores and in a study of patients with chronic adult periodontitis periodontitis Inflammation of soft tissues around the teeth (see tooth). Poor dental hygiene leads to deposition of bacterial plaque on the teeth below the gum line, irritating and eroding nearby tissues. in which CRx-102 demonstrated a statistically significant reduction in C-reactive protein C-Reactive Protein Definition C-reactive protein (CRP) is a protein produced by the liver and found in the blood. Purpose C-reactive protein is not normally found in the blood of healthy people. . In addition, CRx-102 is currently being evaluated in a Phase 2 clinical trial in patients with 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. . CRx-102 is one of a portfolio of six product candidates that CombinatoRx is currently testing in Phase 2 clinical trials. 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 foot joints. Symptoms of osteoarthritis range from stiffness and intermittent mild pain to severe joint pain and impaired biomechanical function. Although there is no cure for most forms of osteoarthritis, various therapies can help patients manage symptoms such as non-steroidal anti-inflammatory drugs Non-steroidal anti-inflammatory drugs (NSAIDs) Aspirin, ibuprofen, naproxen, and many others. Mentioned in: Mastocytosis , COX-2 inhibitors Cox-2 Inhibitors Definition Cox-2 inhibitors are non-steroidal anti-inflammatory drugs (NSAIDs) which selectively inhibit cyclooxygenase-2. The cyclooxygenases are required for the creation of prostaglandins. , local analgesics Analgesics Definition Analgesics are medicines that relieve pain. Purpose Analgesics are those drugs that mainly provide pain relief. , 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 is a biopharmaceutical company focused on developing new medicines built from synergistic combinations of approved drugs, designed to attack disease on multiple fronts. CombinatoRx applies its proprietary combination drug discovery technology to identify new combination product candidates in a number of disease areas, including immuno-inflammatory disease, oncology, metabolic disease, neurodegenerative disease, and infectious disease. We are currently developing a portfolio of six product candidates targeting multiple diseases which were discovered by applying our proprietary screening technology. For further information, please visit the CombinatoRx website at 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 the clinical trial results for CRx-102, the Company's plans for further research and development of its CRx-102 product candidate, its plans with respect to the research and development of the other product candidates in its portfolio and its drug discovery technology. These forward-looking statements about the future development of CRx-102 and future expectations, plans and prospects of CombinatoRx involve significant risks, uncertainties and assumptions, including risks and uncertainties related to completing additional successful clinical trials of CRx-102 in osteoarthritis, risks related to the ability of CombinatoRx to initiate and successfully complete clinical trials of its product candidates, potential difficulty and delays in obtaining regulatory approval for the sale and marketing of its product candidates, the unproven nature of the Company's drug discovery technology, the Company's ability to obtain additional funding for its research and development and those other risks that can be found in the "Risk Factors" section of the CombinatoRx Annual Report 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 projects. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. 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) 2006 CombinatoRx, Incorporated. All rights reserved. |
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