Eisai Successfully Completes Phase II Trial of Eritoran, Drug Candidate for Severe Sepsis.Tokyo, Japan, Aug 30, 2005 - (JCNN JCNN Japan Corporate News Network ) - Eisai announced on August 29 successful results of its phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II of E5564 (generic name eritoran), a drug candidate for treating sever sepsis. In the trial conducted in the US, the company compared three groups: one with high-dose eritoran (105mg per 6 days), another with low-dose eritoran (45mg per 6 days) and a placebo group. The results showed a certain reduction in the absolute mortality rate of the group with high-dose eritoran. Specifically, the rate was reduced by 6.4% compared to the placebo group. E5564, which was developed by the Eisai Research Institute of Boston, is a Lipid A derivative. By antagonizing with TLR TLR Trailer TLR Toll Like Receptor (immunological research) TLR Temple (University) Law Review TLR Twin Lens Reflex TLR Texas Law Review TLR The Last Resort (gaming clan) 4 differentially, E5564 blocks the receptor signal transduction. Subsequently, it inhibits the release of inflammatory cytokines IL-1 and TNF TNF abbr. tumor necrosis factor TNF, n an abbreviation for tumor necrosis f , and suppresses the development of severe sepsis. After consulting with the regulatory authorities in the US and Europe, Eisai aims to start a phase III trial within this fiscal year. The US Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) gave E5564 a fast track designation in July 1999. Source: JCN http://www.japancorp.net Copyright [c] 2005 Japan Corporate News Network. All rights reserved. |
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