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MediciNova Initiates Dosing in Phase II Asthma Trial

Posted on: Tuesday, 24 June 2008, 09:03 CDT

MediciNova has initiated dosing in a Phase II clinical trial to determine the safety and efficacy of MN-221 in patients with moderate to severe, but stable asthma.

This is the second Phase II trial currently underway to evaluate MN-221 in various populations of asthma patients. This randomized, open-label, placebo-controlled Phase II clinical trial will involve approximately 15 to 25 patients in two dose cohorts at four clinical sites in the US.

Each patient will receive MN-221 at doses of up to 1,125 micrograms or placebo in a continuous intravenous infusion of up to two hours. Safety and preliminary efficacy data, including changes in forced expiratory volume in one second, will be collected and summarized; however, the data will not be subjected to inferential statistical analysis.

The data from this clinical trial, along with the other Phase II clinical trial in severe, acute exacerbations of asthma, will aid in the design of a larger Phase IIb emergency department (ED) clinical trial, which is anticipated to begin toward the end of 2008, as well as a future Phase III ED clinical trial, the company said.

Yuichi Iwaki, president and CEO of MediciNova, said: "This clinical trial will provide us with an initial observation into the potential safety and efficacy of MN-221 with more prolonged infusions and with different infusion rates in patients with stable, moderate to severe asthma."

Source: Datamonitor

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