Indications -- Asthma/Allergy Message Board

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Biotech / Medical : Indications -- Asthma/Allergy

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To: scaram(o)uche who started this subject	3/27/2003 11:25:39 PM
From: tuck	of 86

[AVN - IgE & Th2] >>SAN DIEGO, March 17 /PRNewswire-FirstCall/ -- AVANIR Pharmaceuticals (Amex: AVN - News) announced today that the U.S. Food and Drug Administration (FDA) has allowed its Investigational New Drug (IND) application for its proprietary small molecule, AVP 13358. AVANIR is developing AVP 13358 as a potential treatment for allergy and asthma. Allowance of the IND permits AVANIR to initiate Phase I clinical trials. The initial Phase I clinical trial to determine single-dose safety of the drug in healthy volunteers is scheduled to begin in April 2003. AVANIR's orally active compound, AVP 13358, is designed to act early in the body's response to allergens by pre-empting the production or release of mediators involved in asthma and allergic rhinitis. The approach is unique because it selectively targets both the production of the IgE antibody that is released by the immune system in response to allergen exposure, and a critical group of cytokines (Th2) thought to regulate the production of the antibody. Existing drugs such as antihistamines act to suppress the symptoms of allergy but have little effect on the development or progression of the disease. "The initiation of this clinical trial represents the accomplishment of our goal of having active drug development programs in all phases of development. We now have an approved product and potential products in Phase III, Phase II and Phase I," said Gerald J. Yakatan, Ph.D., President and CEO of AVANIR Pharmaceuticals. "Our strategy is to initiate our clinical trials program and to partner with a pharmaceutical company interested in working with us to develop this platform technology." No orally active drugs are currently marketed for the treatment of excess IgE or Th2 cytokines, and AVANIR believes that a compound that acts on these critical mediators would provide a valuable new tool for the treatment of asthma and allergic rhinitis.<< snip Cheers, Tuck

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