Arris Pharmaceutical Begins Phase Ib Trials.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.--(BUSINESS WIRE)--March 21, 1995-- Arris ar·ris n. pl. arris or ar·ris·es The sharp edge or ridge formed by two surfaces meeting at an angle, as in a molding. [Alteration of Old French areste, fishbone, spine Pharmaceutical Corporation (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 : ARRS ARRS American Roentgen Ray Society. ) Tuesday announced it has begun Phase Ib multiple dose tolerance studies in human subjects on 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. 366, a tryptase inhibitor for the treatment of asthma, at Guy's Drug Research Unit, London. The Principal Investigator for the Phase Ib trial is Dr. Timothy Mant in collaboration with Professor Tak H. Lee. The Phase Ib study will be a double-blind, placebo-controlled multiple dose tolerance study with 30 subjects. APC 366 will be administered by inhalation three times per day in subjects with hyperresponsive airways, including mild asthmatics, over a four day period. APC 366 will be administered at doses of up to 5 mg, with daily totals of up to 15 mg per day. The highest tolerated dose will be carried into the Phase IIa allergen allergen /al·ler·gen/ (al´er-jen) an antigenic substance capable of producing immediate hypersensitivity (allergy).allergen´ic pollen allergen challenge studies which are expected to begin mid-year. The phase II studies will be the first studies designed to show the effect of tryptase inhibitors in man. The Company has completed three 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. , double-blind phase Ia studies of APC 366 carried out in over 100 healthy volunteers and mild asthmatics in the U.K. and the U.S. Mild asthmatic subjects were selected on the basis of bronchial hyperresponsiveness bronchial hyperresponsiveness Exaggerated bronchial constriction most common in asthma, in response to nonspecific provocation, inhalation of various bronchoconstrictors, but also to physical challenges–eg, exercise, dry or cold air, hypertonic or hypotonic aerosols to inhaled histamine or methacholine as measured by a corresponding drop in pulmonary function (FeV1). "APC 366 appears to be well tolerated at dose levels which have shown therapeutic benefits in preclinical experiments," said Heinz W. Gschwend, Arris' vice president, Research and Development, "These multiple dose tolerance studies will assist us in determining dosage levels for our Phase II allergen challenge studies." Arris' inflammation program focuses on development of novel therapeutics based on inhibiting tryptase and chymase. These proteases are regulatory enzymes believed to play important roles in initiating and amplifying inflammatory events in the body, thus contributing to diseases such as asthma, allergic rhinitis and allergic conjunctivitis. Arris has developed a number of highly potent and selective inhibitors of tryptase and has a collaboration with Bayer AG to develop orally active inhibitors of both enzymes. Arris retains the responsibility to develop APC 366 through the initial Phase IIa studies and Bayer will have the responsibility for the pre-clinical and clinical development of new compounds. Arris Pharmaceutical is engaged in the discovery and development of synthetic small molecule therapeutics that modulate the activity of medically important proteins. The company is focusing its initial product development programs on protease-based therapies for human inflammatory diseases and on oral 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). and growth factor mimetics. The company's structure-based drug design approach is supported by a proprietary artificial intelligence technology designed to shorten the drug discovery and development cycle. CONTACT: Arris Pharmaceutical John P. Walker or Patty Lord, 415/737-8600 |
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