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MediciNova Announces Positive Clinical Results From MN-166 Phase II,Multiple Sclerosis Trial

al MRI scans over 12 months of treatment was observed in patients treated with MN-166 compared to placebo, which was the protocol-defined primary endpoint of the study. No clinical or radiological benefit was observed in patients treated with 30 mg per day of MN-166. MN-166 was well tolerated at all doses in this trial. Eighty-nine percent of patients completed the first 12 months of the trial with only mild gastrointestinal side effects observed with MN-166 compared to placebo (3-6% vs. 1-3%, respectively).

The independent Data Safety Monitoring Board (DSMB) has recommended that the trial continue beyond the first year of treatment without modification and was supportive of further clinical evaluation of MN-166 in MS patients.

"We are pleased with the benefit of MN-166 observed in MS patients in this trial; they confirm the results of previous pilot trials of MN-166 in MS patients conducted by Japanese academic investigators," said Yuichi Iwaki, M.D., Ph.D., Executive Chairman and CEO of MediciNova, Inc. "The divergence of clinical benefit and radiological findings suggest that MN-166 may be acting by a different mode of action than current treatments. We will carefully analyze the clinical data with our independent advisors to determine next steps in the development program and to advance this compound into Phase III clinical testing."

In July 2005, MediciNova initiated a randomized, double-blind, placebo-controlled multi-center Phase II clinical trial of MN-166 in MS patients in five Eastern European countries. A total of 297 patients with at least one gadolinium-enhancing lesion on a screening visit MRI scan were randomized to receive placebo or one of two doses of MN-166 (30 or 60 mg per day) in this trial. Safety and efficacy assessments were performed at months 1, 2, 4, 6, 8, 10 and 12 of the trial. Efficacy assessments were based on the evaluation of the cumulative number of active (gadolinium-enhancing (T1) and non-enhancing new/enlargi
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