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TANOX AND CIBA ANNOUNCE COMMENCEMENT OF CLINICAL TESTING OF NEW ALLERGY TREATMENT

 HOUSTON, June 16 /PRNewswire/ -- Tanox Biosystems Inc. (Houston) and Ciba-Geigy Ltd. (Basel, Switzerland) announced today the commencement of clinical testing under Phase I of a monoclonal antibody being developed for the treatment of IgE-mediated diseases, which include allergies.
 The product, identified under Ciba's nomenclature as CGP 51901 and referred to by Tanox as AL-901, is an anti-IgE monoclonal antibody developed by Tanox scientists. The product is being jointly developed for therapeutic use by Tanox and Ciba under an agreement signed in 1990. Preclinical studies performed with the product have shown that it has the ability to remove circulating IgE, the mediating agent in allergic reactions, and to mediate certain immune system functions that should eliminate or suppress the B cells responsible for producing IgE.
 According to Dr. Tse Wen Chang, Tanox's vice president of research and development, allergic reactions are triggered when an allergen binds to and cross-links the allergen-specific IgE antibodies that are bound to histamine-containing cells in the body known as mast cells and basophils. "Based on the trial design, we will be able to evaluate in our Phase I study whether or not CGP 51901 can successfully reduce IgE levels, as well as determine how long the effect will last. This information should provide us with an important indication of the product's potential for treatment of allergies and allergic asthma," said Dr. Chang.
 The planned study will take place in Southampton, England, under authority of a Clinical Trial Certificate Exemption (CTX), which has been approved by the United Kingdom's Medicines Control Agency and an Investigational New Drug Application (IND) approved by the Food and Drug Administration in the United States. The principal investigator for the study will be Professor Stephen T. Holgate, a widely regarded expert in the allergy field, who is MRC Clinical Professor of Immunopharmacology at the University of Southampton. The clinical trial is designed as a double-blind, single-intravenous dose, safety and tolerability study. The trial volunteers will be persons with elevated IgE levels and will be divided into four groups consisting of nine persons per group, six receiving CGP 51901 and three receiving placebo. The groups will be dosed consecutively with each group receiving a larger dose than the previous group.
 The primary aim of the Phase I study is to evaluate the safety and tolerability of the product; however, secondary aims will include assessing the ability of the product to decrease serum IgE, the duration of such decrease, and the effect of such decrease on skin reactivity to allergens. Final evaluation of the results of the Phase I study is expected to be completed by the end of 1993, although planning is already in progress for clinical trials to assess the product's efficacy in allergic rhinitis.
 Tanox Biosystems Inc., incorporated in 1986, is a biotechnology research and development company based in Houston. Tanox Biosystems is a leader in the development of novel monoclonal antibody-based treatments for diseases involving or affecting the human immune system.
 Ciba, headquartered in Switzerland, is one of the world's largest chemical and pharmaceutical companies. Ciba's Pharmaceutical Division is the world's fourth largest specialty pharmaceutical producer, with 1992 specialty sales of SFr. 6.441 million.
 -0- 6/16/93
 /CONTACT: David Anderson of Tanox Biosystems, 713-664-2288/


CO: Tanox Biosystems, Ciba-Geigy Ltd. ST: Texas IN: MTC SU:

LM-JB -- LA004 -- 2518 06/16/93 10:00 EDT
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Publication:PR Newswire
Date:Jun 16, 1993
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