Axys Pharmaceuticals Initiates Phase I Clinical Trial of its Tryptase Inhibitor for Acute Inflammatory Bowel Disease, APC-2059.SOUTH SAN FRANCISCO South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , Calif.--(BW HealthWire)--Dec. 1, 1998--Axys Pharmaceuticals, Inc. (Nasdaq:AXPH) announced today that it has initiated a Phase I double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability and pharmacokinetics (how the human body absorbs, metabolizes, distributes and excretes a drug) of its lead drug candidate, APC-2059, in 42 healthy subjects. APC-2059 has been developed to inhibit tryptase, a serine protease which has a demonstrated involvement in inflammation. The company is developing APC-2059 as a potential treatment for diseases associated with inflammation including inflammatory bowel disease inflammatory bowel disease n. Abbr. IBD Any of several incurable and debilitating diseases of the gastrointestinal tract characterized by inflammation and obstruction of parts of the intestine. (IBD IBD abbr. inflammatory bowel disease Inflammatory bowel disease (IBD) Disease in which the lining of the intestine becomes inflamed. Mentioned in: Amebiasis IBD 1. ). Inflammatory bowel disease generally refers to two diseases, Crohn's Disease Crohn's disease: see colitis. and Ulcerative Colitis ulcerative colitis Inflammation of the colon, especially of its mucous membranes. The inflamed membranes develop patches of tiny ulcers, and the diarrhea contains blood and mucus. . Over 300,000 people in the U.S. suffer from IBD, however, none of the current therapies, which include the use of corticosteroids Corticosteroids Definition Corticosteroids are group of natural and synthetic analogues of the hormones secreted by the hypothalamic-anterior pituitary-adrenocortical (HPA) axis, more commonly referred to as the pituitary gland. and immunosuppressants immunosuppressants, n.pl the agents that lower or reduce immune response; useful in organ transplant surgery to prevent organ rejection. Corticosteroid hormones given in large amounts; cytotoxic drugs, including antimetabolites and alkylating agents; such as cyclosporine cyclosporine /cy·clo·spor·ine/ (-spor´en) a cyclic peptide from an extract of soil fungi that selectively inhibits T cell function; used as an immunosuppressant to prevent rejection in organ transplant recipients and to treat severe and methotrexate methotrexate, drug used in halting the growth of actively proliferating tissues. Introduced in the 1950s, it is used in the treatment of leukemia, psoriasis, and non-Hodgkin's lymphoma. , offer a cure for the disease. Tryptase is released by mast cells in response to different stimuli, including allergens. When released, tryptase contributes to a cascade of biological events which result in inflammation. "By inhibiting tryptase, through the use of APC-2059, we hope to slow or halt the inflammatory process at an early stage, thereby slowing the progression of the disease as well as alleviating the symptoms," stated Jean Warner, M.D., Axys' vice president of medical affairs. "We believe that inhibition of tryptase represents an important new mechanism that will allow the development of a new class of compounds for the treatment and prevention of a host of inflammatory diseases and disorders," stated John Walker, chairman and chief executive officer of Axys. "Upon successful completion of our Phase I studies of APC-2059 for acute inflammatory bowel disease, we anticipate initiating Phase II clinical trials in 1999." Axys Pharmaceuticals is a leader in the integration of life science technologies with a focus on transforming gene discoveries into drugs. The company has research collaborations with world-class pharmaceutical companies, covering a broad range of therapeutic areas, including respiratory, cardiovascular, and infectious disease, as well as oncology and central nervous system disorders Nervous system disorders A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency . Except for the historical information contained herein, this press release contains forward-looking statements that involve risks and uncertainties which could cause Axys' actual results to differ materially from those discussed here, including the risk that clinical trials will not proceed as anticipated or may not be successful, the risk of Axys' early stage of development, Axys' reliance on the efforts of its collaborative partners, the risk that Axys' collaborations will not be successful, the risk that Axys will not be successful in entering into new collaborations, competition, the risk of unexpected difficulties and delays in the development of new technologies, and general economic conditions that may affect Axys' actual results and developments. Additional factors that could cause or contribute to such differences include, but are not limited to, those discussed in the sections entitled "Business" and "Additional Risk Factors" in the company's SEC Reports, including the company's report on Form 10-K for the fiscal year ended December 31, 1997. For more information on Axys Pharmaceuticals, Inc., please visit the company's website at http://www.axyspharm.com. |
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