To: scaram(o)uche who wrote (269 ) 5/26/1999 10:38:00 AM From: bob zagorin Respond to of 455
Axys Pharmaceuticals Initiates Phase II Human Clinical Trials of Topical Tryptase Inhibitor for the Treatment of Psoriasis SOUTH SAN FRANCISCO, Calif.--(BW HealthWire)--May 26, 1999--Axys Pharmaceuticals Inc. (Nasdaq:AXPH) today announced that it has initiated a Phase II study of APC 2059 to evaluate the safety and effectiveness of a topically administered cream formulation for the treatment of mild to moderate psoriasis. The company has successfully completed Phase Ia and Phase Ib studies of APC 2059 for this indication and, in March 1999, Axys also successfully completed Phase Ib testing of an injectable formulation of APC 2059 for the treatment of inflammatory bowel disease. APC 2059 is a proprietary Axys compound and a member of a class of synthetic small molecule compounds designed to inhibit tryptase, which is an enzyme found in mast cells that have been demonstrated to be involved in inflammatory diseases. In this Phase II human clinical study, APC 2059 will be evaluated in a placebo control designed study focused on the bilateral component of psoriasis. A cream will be applied to matched psoriatic lesions of each subject. One side will receive APC 2059 and the other will receive placebo. An independent dermatologist will evaluate and compare the treated areas to determine relative improvement between the two sides. "With APC 2059 for psoriasis entering Phase II human studies, our tryptase program continues to make solid progress," said John Walker, chairman and chief executive officer of Axys Pharmaceuticals Inc. "This compound demonstrated an excellent safety profile in Phase I studies and we continue to have high expectations that the inhibition of tryptase represents a novel approach to the treatment of a number of diseases associated with mast cell mediated inflammation." Psoriasis is an autoimmune skin disorder resulting in excessive skin cell reproduction. The disease has several different clinical presentations, which are most often characterized by raised, inflamed lesions covered with a scaly white buildup of dead skin cells. Nearly seven million people in the U.S. suffer from various forms of psoriasis, however, none of the current treatments, including topical steroids and immunosuppressants, offer reliable relief. Axys Pharmaceuticals is a leader in the integration of life science technologies with a focus on transforming gene discoveries into drugs. Axys is building shareholder value through (1) a broad and diversified pipeline of research and development programs partnered with world-class pharmaceutical companies; (2) expansion of a non-partnered research and development franchise in oncology; and (3) the spin out of affiliated businesses that leverage the company's technologies in order to provide capital for Axys' drug discovery and development programs. Axys' technology-leveraging businesses are: The Advanced Technologies Division, a combinatorial chemistry oriented business; PPGx Inc., a majority owned pharmacogenomics company; and Xyris Corporation, a majority owned agricultural biotechnology company. 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, Axys' reliance on the efforts of its collaborative partners, the risk that Axys' collaborations will not be successful, the risk of Axys' early stage of development, 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?" in the company's SEC Reports, including the company's report on Form 10-K for the fiscal year ended Dec. 31, 1998. For more information on Axys Pharmaceuticals Inc., please visit the company's website at axyspharm.com . --30--pw/sf* mr/sf CONTACT: Axys Pharmaceuticals Inc., South San Francisco John Walker or David Gennarelli, 650/829-1000 or Burns McClellan Inc. John Nugent, 212/213-0006