Array BioPharma's p38 Inhibitor for Inflammatory Disease to Advance into Human Clinical Trials.Phase 1 Trial Expected to Commence in Fall 2006 BOULDER, Colo. -- Array BioPharma Inc. (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 : ARRY) filed an Investigational New Drug (IND) application for ARRY-797 with the U.S. Food & Drug Administration and is now able to proceed with human clinical studies. ARRY-797 is a potent, selective, orally active inhibitor of p38 MAP kinase and has demonstrated good tolerability and significant efficacy in preclinical models of human inflammatory diseases. The compound will initially be evaluated in dose escalation studies in normal, healthy volunteers for safety, exposure and inhibition of mechanism-related biomarkers. "Advancing ARRY-797, our small molecule p38 inhibitor, into clinical trials is a significant achievement for Array and marks our third drug to enter clinical development during 2006," said Kevin Koch, Ph.D., President and Chief Scientific Officer. "This novel p38 inhibitor, derived from our computational de novo [Latin, Anew.] A second time; afresh. A trial or a hearing that is ordered by an appellate court that has reviewed the record of a hearing in a lower court and sent the matter back to the original court for a new trial, as if it had not been previously heard nor decided. design technology platform, holds promise for the treatment of patients with arthritis and other inflammatory diseases." About Inflammatory Disease Inflammation is a natural biologic response to injury or infectious attack to the human body. Unregulated inflammation results in a broad range of conditions, most of which are classified by the tissue or organ where the inflammation occurs. These conditions include 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. (RA) in the joint, psoriasis in the skin, chronic obstructive pulmonary disease chronic obstructive pulmonary disease n. Abbr. COPD A chronic lung disease, such as asthma or emphysema, in which breathing becomes slowed or forced. in the lung, fibrotic disease in the liver and kidney, Crohn's disease Crohn's disease: see colitis. in the intestine, and congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. and arteriosclerosis arteriosclerosis (ärtĭr'ēōsklərō`sis), general term for a condition characterized by thickening, hardening, and loss of elasticity of the walls of the blood vessels. in the arteries, among others. Currently, some of the most effective treatments for these diseases are injectable protein therapeutics, which have significant cost and patient compliance issues. Injectable protein therapeutics currently on the market - such as Enbrel[R], Remicade[R], Humira[R] and Kineret[R] - bind to and/or modulate the activity of the inflammatory 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. TNF-[eth] or IL-1 and are utilized for the treatment of RA, psoriasis and Crohn's disease. The TNF TNF abbr. tumor necrosis factor TNF, n an abbreviation for tumor necrosis f inhibition market alone, which is dominated by these therapeutics, is expected to grow from $9 billion in 2005 to $17 billion in 2010, according to analyst estimates. About ARRY-797 / p38 for Inflammation and Cancer p38 MAP kinase is an enzyme that regulates the production of numerous pro-inflammatory or growth promoting cytokines, in particular, TNF, IL-6 and IL-1. Up-regulation of TNF and IL-6 may be involved in certain tumor resistance mechanisms and has been observed in several malignancies including prostate and ovarian cancer ovarian cancer Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast and multiple myeloma multiple myeloma A malignant proliferation of abnormal plasma cells that populate the marrow-containing bones of the body. The affected plasma cells produce myeloma protein, a monoclonal antibody that replaces normal antibodies in the blood, thereby increasing susceptibility . ARRY-797, an orally active p38 inhibitor, has demonstrated good tolerability and significant efficacy in preclinical models of human inflammatory diseases and certain cytokine-driven cancers. About Array BioPharma: Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat life threatening and debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction diseases. Our proprietary drug development pipeline is focused on the treatment of cancer and inflammatory disease and includes clinical candidates that are designed to regulate therapeutically important protein targets. In addition, leading pharmaceutical and biotechnology companies collaborate with Array to discover and develop drug candidates across a broad range of therapeutic areas. For more information on Array, please go to www.arraybiopharma.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 that involve significant risks and uncertainties, including those discussed in our annual report filed on form 10-K for the year ended June 30, 2006, and in other reports filed by Array with the Securities and Exchange Commission. Because these statements reflect our current expectations concerning future events, our actual results could differ materially from those anticipated in these forward-looking statements as a result of many factors. These factors include, but are not limited to, our ability to continue to fund and successfully progress internal research efforts and to create effective, commercially viable drugs, our ability to achieve and maintain profitability, the extent to which the pharmaceutical and biotechnology industries are willing to in-license drug candidates for their product pipelines and to collaborate with and fund third parties on their drug discovery activities, our ability to out-license our proprietary candidates on favorable terms, risks associated with our dependence on our collaborators for the clinical development and commercialization of our out-licensed drug candidates, the ability of our collaborators and of Array to meet objectives tied to milestones and royalties, and our ability to attract and retain experienced scientists and management. We are providing this information as of October 31, 2006. We undertake no duty to update any forward-looking statements to reflect the occurrence of events or circumstances after the date of such statements or of anticipated or unanticipated events that alter any assumptions underlying such statements. |
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