CombinatoRx Reports Preliminary Data for Drug Candidate CRx-119 in an Exploratory Immuno-Inflammatory Disease Model; Does Not Meet Primary Endpoint of Reduction of C-Reactive Protein, Analysis of Cytokines is Ongoing.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 preliminary 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 clinical trial of CRx-119 in 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. , an immuno-inflammatory disease model. This study was designed as an exploratory study to allow CombinatoRx to compare and contrast the immuno-inflammatory properties of our portfolio of immuno-modulating product candidates. The study did not show a 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. (CRP C-reactive protein (CRP) A protein present in blood serum in various abnormal states, like inflammation. Mentioned in: Pelvic Inflammatory Disease CRP, n.pr See C-reactive protein. ), the primary endpoint, or a reduction of periodontal pocket depth, one of the secondary endpoints. Other secondary endpoints in the study include a panel of immuno-modulatory cytokines Cytokines Chemicals made by the cells that act on other cells to stimulate or inhibit their function. Cytokines that stimulate growth are called "growth factors. , the analysis of which is ongoing. CRx-119 is a novel synergistic combination drug candidate discovered using the CombinatoRx combination High Throughput Screening (cHTS(TM)) technology with potential therapeutic use in a broad range of immuno-inflammatory conditions. CRx-119 is a combination of 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, , 3mg, and amoxapine. CRx-119 was generally well tolerated and there were no drug-related serious adverse events reported. The most common adverse event observed with CRx-119 was drowsiness drows·i·ness n. A state of impaired awareness associated with a desire or inclination to sleep. Also called hypnesthesia. drowsiness Medtalk Semiconsciousness; grogginess, sleepiness , a known side-effect of amoxapine. "While the preliminary results of CRx-119 in chronic periodontal disease Periodontal Disease Definition Periodontal diseases are a group of diseases that affect the tissues that support and anchor the teeth. Left untreated, periodontal disease results in the destruction of the gums, alveolar bone (the part of the jaws where are disappointing, the product candidate demonstrates a good safety profile. This exploratory study was designed to evaluate the cytokine Cytokine Any of a group of soluble proteins that are released by a cell to send messages which are delivered to the same cell (autocrine), an adjacent cell (paracrine), or a distant cell (endocrine). modulating profile of CRx-119 in a model of immuno-inflammatory disease. Our selection of indications for development will be based on the ongoing analysis of this study and a comparison of the results across the multiple biomarker studies of our other product candidates." said Dr. Jan Lessem, Chief Medical Officer of CombinatoRx. "This is one of several exploratory immuno-inflammatory disease model studies currently underway. It would be premature to arrive at conclusions prior to analyzing the cytokine data from this and the other studies. We are also looking forward to the CRx-119 Phase 2 results 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. available early next year," commented 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. CRx-119 is currently in a phase 2 clinical trial phase 2 clinical trial Phase 2 study. See Phase study. in patients with rheumatoid arthritis. CRx-119 is one of a portfolio of six product candidates that CombinatoRx is currently testing in phase 2 clinical trials. About the Trial Design This clinical trial was a multi-center, blinded, placebo-controlled, randomized study of the effect of a 6-week treatment of CRx-119 in combination with scaling and root planning (SRP SRP - A data link layer protocol. ) compared to placebo and SRP in a 1:1 ratio. The primary endpoint was CRP reduction in patients with adult periodontitis, a bacterial disease of the gums with an inflammatory component. Secondary endpoints of the study included reduction in periodontal pocket depth and changes in inflammatory cytokine levels. Patients were enrolled into the trial with chronic periodontitis, defined as a minimum of 10 pockets between the teeth and gum measuring greater than 5mm in depth with at least 4 pockets greater than 6mm. Half of all the pockets must bleed on probing. Baseline CRP levels upon enrollment had to be greater than 1.8mg/L. CRx-119 was dosed in this trial using 3mg of prednisolone and three different doses of amoxapine. Patients received the first ratio for the first week of treatment, the second ratio for the second week, and the third ratio for the following four weeks. SRP of the subjects' teeth was conducted prior to dosing with CRx-119. Inflammatory cytokine levels were measured throughout the study. Sixty-two patients were enrolled in the trial at four study centers in the United States. About CRx-119 CRx-119 is a novel orally available 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 in clinical development for immunoinflammatory diseases. A syncretic drug comprises two compounds that are designed to act together 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-119 contains a low dose of the steroid prednisolone and amoxapine. The target product profile for CRx-119 is to selectively amplify certain elements of prednisolone's anti-inflammatory and immunomodulatory effects, without replicating steroid toxicity. About CRP and Periodontitis Periodontitis is a bacterial disease of the gums with an inflammatory component that is associated with an increase in plasma C-reactive protein (CRP), an acute phase protein Acute-phase proteins are a class of proteins whose plasma concentrations increase (positive acute phase proteins) or decrease (negative acute phase proteins) in response to inflammation. This response is called the acute-phase reaction (also called acute phase response). and marker of systemic inflammation. The relationship between inflammatory processes and elevation of CRP has been established in periodontitis and in other immuno-inflammatory diseases. 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 immunoinflammatory disease, oncology, metabolic disease, neurodegenerative disease, and infectious disease. We are currently developing a portfolio of 6 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 CombinatoRx's clinical trial results for CRx- 119, its plans for further research and development of its CRx-119 product candidate, the predictive value of CRP and clinical trials in chronic adult periodontitis for other immunoinflammatory diseases, its plans with respect to the research and development of the other product candidates in its portfolio, its timeframe for the announcement of results from clinical trials of its other product candidates and its drug discovery technology. These forward-looking statements about the future development of CRx-119 and future expectations, plans and prospects of CombinatoRx involve significant risks, uncertainties assumptions, including risks related to whether a clinical trial in chronic adult periodontitis or the measure of CRP is predictive of efficacy in other immuno-inflammatory diseases, the ability of CombinatoRx to design future clinical trials of CRx-119 in other immuno-inflammatory diseases based on data from a clinical trial from a different immuno-inflammatory disease, CombinatoRx's ability 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 CombinatoRx's 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 CombinatoRx'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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