Daiichi Sankyo Announces Completion of Phase I Trial on the Anti-influenza Drug CS-8958.Tokyo, Japan, Apr 19, 2007 - (JCN JCN Japan Corporate News JCN Journal of Cognitive Neuroscience JCN Journal of Cardiovascular Nursing JCN Journal of Christian Nursing JCN Job Control Number JCN Journal of Child Neurology JCN joint communications network (US DoD) Newswire) - Daiichi Sankyo Company, Limited announced today that it has completed a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I in Japan on the Daiichi Sankyo-originated anti-influenza drug CS-8958 and expects to start Phase II trials this fall. CS-8958 is a long-acting neuraminidase inhibitor that is expected to be used as single administration for treatment and once a week for prophylaxis. The compound is under development as an inhalant inhalant /in·hal·ant/ (in-hal´ant) 1. something meant to be inhaled; see inhalation (def. 3). 2. a class of psychoactive substances whose volatile vapors are subject to abuse. that will act directly on the pulmonary and tracheal tracheal pertaining to or emanating from trachea. tracheal aspiration see transtracheal aspiration. tracheal band sign on contrast radiography of a dilated esophagus, the impression made ventrally by the trachea. sites of infection. Non-clinical studies have confirmed its effectiveness against the H5N1 avian influenza virus in addition to its effectiveness against both A and B type seasonal influenza viruses. CS-8958 was designated as a priority consultation product by the Pharmaceuticals and Medical Devices Agency (PMDA PMDA Plastics Machinery Distributors' Association (United Kingdom) PMDA Plutonium Management and Disposition Agreement (US-Russia) PMDA Pharmaceuticals and Medical Device Agency (Japan) ) in August 2006, which will give it priority for consultations on clinical trial planning and other issues. Daiichi Sankyo aims to file an NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any at the end of 2009 and is pursuing development in full consultation with the regulatory authorities and specialists. As measures to deal with new strains of influenza virus are enhanced, CS-8958 may make an important contribution by increasing the range of options available for treating and preventing flu infections. In Europe and the US, Australia-based Biota Holdings Ltd., a joint development company, is conducting Phase I trials for CS-8958. About Daiichi Sankyo Co., Ltd. Daiichi Sankyo Company, Limited (TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). : 4568), was established on September 28, 2005 as the joint holding company of two major Japanese pharmaceutical companies - Sankyo Company, Limited and Daiichi Pharmaceutical Co., Ltd. Daiichi Sankyo is a global pharmaceutical innovator, continuously generating innovative drugs and services and maximizing its corporate value. Sankyo and Daiichi Pharmaceutical have a broad range of major drug products on the Japanese market, including the antihypertensive antihypertensive /an·ti·hy·per·ten·sive/ (-ten´siv) counteracting high blood pressure, or an agent that does this. an·ti·hy·per·ten·sive adj. Reducing high blood pressure. n. Benicar (olmesartan medoxomil) and the synthetic antibacterial agent Cravit (levofloxacin). Both companies have used their cumulative knowledge and expertise in the field of cardiovascular disease as a foundation for developing an abundant product lineup and R&D pipeline. For more information, please visit www.daiichisankyo.co.jp. Source: Daiichi Sankyo Co., Ltd. Contact: Daiichi Sankyo Company, Limited Corporte Communications Department Tel: +81-3-6225-1111 Copyright [c] 2007 JCN Newswire. All rights reserved. A division of Japan Corporate News Network K.K. |
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