Axys Pharmaceuticals Announces Bayer AG's Decision to Discontinue Development of BAY 44-3428 for Asthma.Business Editors/Health & Medical Writers 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)--May 24, 2000 Axys' Phase II Clinical Trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II of APC (1) (American Power Conversion Corporation, West Kingston, RI, www.apcc.com) The leading manufacturer of UPS systems and surge suppressors, founded in 1981 by Rodger Dowdell, Neil Rasmussen and Emanual Landsman, three electronic power engineers who had worked at MIT. 2059 in 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. Will Not Be Affected by this Decision Axys Pharmaceuticals, Inc. (Nasdaq:AXPH) announced today that its collaboration partner Bayer AG Bayer AG German chemical and pharmaceutical company. Founded in 1863 by Friedrich Bayer (1825–1880), it now operates plants in more than 30 countries. Bayer has originated scores of pharmaceuticals, chemicals, and synthetic materials; it was the first developer and has decided to discontinue development of BAY 44-3428. Bayer AG had previously selected BAY 44-3428 for development as an oral treatment for asthma based on the demonstrated in vivo in vivo /in vi·vo/ (ve´vo) [L.] within the living body. in vi·vo adj. Within a living organism. in vivo adv. efficacy of the compound in primate models of asthma. Bayer's decision to discontinue development of BAY 44-3428 was based on its view that the toxicological properties of this specific compound precluded advancement into clinical development. Axys and Bayer AG are in discussions about the future of their collaboration in tryptase inhibition in light of this decision. Today's announcement does not affect Axys' Phase II clinical trial of APC 2059, a tryptase inhibitor currently being developed for the treatment of acute 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. . APC 2059, which is a second generation tryptase inhibitor developed in the collaboration with Bayer AG, is from a chemically distinct class of compounds from the third generation compound BAY 44-3428, and does not demonstrate the toxicological properties that were found with BAY 44-3428. Axys previously demonstrated proof of principle for tryptase as a target in inflammation in two Phase II trials of a first generation compound, APC 366. Those trials, completed in the United Kingdom, demonstrated that APC 366 could alleviate symptoms associated with allergen-induced asthma, with statistically significant results in the reduction of the late airway response as measured against both baseline and placebo. John Walker, chairman and chief executive officer of Axys, stated, "While we are disappointed with the discontinuation dis·con·tin·u·a·tion n. A cessation; a discontinuance. Noun 1. discontinuation - the act of discontinuing or breaking off; an interruption (temporary or permanent) discontinuance of development of BAY 44-3428, we support Bayer's decision with respect to this compound. We continue to believe that tryptase inhibition is a viable mode of therapeutic intervention for the treatment of asthma, acute inflammatory bowel disease, specifically ulcerative colitis, and other mast cell mast cell n. A cell found in connective tissue that contains numerous basophilic granules and releases substances such as heparin and histamine in response to injury or inflammation of bodily tissues. Also called labrocyte, mastocyte. mediated inflammatory disorders. We are exploring with Bayer AG whether they are interested in pursuing for development as a treatment for asthma other compounds developed in the collaboration that lack the toxicological properties of BAY 44-3428." Axys Pharmaceuticals, Inc. is an integrated small molecule drug discovery and development company. Axys has a broad pipeline of products for chronic therapeutic applications that are partnered with world-class pharmaceutical companies and a proprietary product portfolio in oncology. Axys is also building shareholder value through affiliated businesses that leverage the Axys technologies in order to provide capital for Axys' drug discovery and development programs. In addition to the minority interest in Discovery Partners International, Inc., which recently acquired Axys Advanced Technologies, Inc., Axys' technology leveraging businesses are: PPGx, a majority-owned pharmacogenomics Pharmacogenomics is the branch of pharmacology which deals with the influence of genetic variation on drug response in patients by correlating gene expression or single-nucleotide polymorphisms with a drug's efficacy or toxicity. company, and Akkadix Corporation, a minority-owned agricultural biotechnology company. Except for the historical information contained herein, this press release contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. that involve risks and uncertainties which could cause Axys' actual results to differ materially from those discussed here, including the risks inherent in early stage development and the reliance on the efforts of collaborative partners, the risk that this or other Axys collaborations will not be successful, the risk that clinical trials will not proceed as anticipated or may not be successful, the risk that Axys will not be successful in entering into new collaborations, competition and marketing risk, the risk of unexpected difficulties and delays in the development of new technologies and in expanding its manufacturing capabilities, 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 "What Factors Could Cause Our Results to Differ Significantly from Those You Might Expect?" and "What Other Matters Should Stockholders Consider with Respect to Axys?" in the Axys' SEC Reports, including Axys' report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the fiscal year ended December 31, 1999. |
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