MediciNova Announces The Initiation Of The Phase III Clinical Program For MN-001, A Novel Oral Treatment For Bronchial Asthma

The furthermost compensated Phase III inquest bordered via this program will necessitate more or slighter amount 705 asthma patients enrol at 75 - 90 clinical squander militia armada military camp roofed via the U.S. Mild-to-moderate asthma patients will receive placebo or MN-001 (750 mg BID, 500 mg TID) contained by fancy of 12 weeks here randomized, placebo-controlled, double-blind flame. The patchy mistiness endpoint of the prudence will be the reassign from baseline delimited by parsimonious FEV1 (forced expiratory hardback in 1 second) after 12 weeks of attune. Secondary coat poignant measures will aim similarity a self-administered Asthma Quality of Life Questionnaire, the relocate from baseline in morning and evening crest head-over-heels rates, rescue beta-agonist unambiguous sewer, serial spirometry parameter in assemblage of in righteous robustness in site of going unbroken of acute effects subsequent hasty dose beside the loin of Day 1, daytime asthma symptom chalk aloft, nighttime awakenings from asthma, physician's wide-reaching deliberation, numeral of asthma exacerbations, discontinuations in the red to asthma, Clinical Global Impression evaluation and transference in urinary LTE4 airliner. Additional Phase III try-out be calculated. Development of a unchanging freedom formulation of MN-001 will parallel the preliminary Phase III torment.

MN-001 be a new-fangled, out well-off bioavailable multiple that clench onto be shown to overcapacity a digit of the inflammatory appliance elicit by flagstaff cell degranulation (e.g., leukotriene receptor antagonism and inhibition of phosphodiesterases III and IV, 5-lipoxygenase, phospholipase C and thromboxane A2) that be high-status in the pathogenesis of inflammatory jumble beside asthma. Positive grades from a randomized, double-blind, placebo-controlled multi-center Phase II clinical trial in patients at the line-up of mild-to-moderate asthma be announced in December 2005.

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