MediciNova completes enrollment in a phase 2 multiple sclerosis trial of MN-166

By E. Janene Geiss

Philadelphia, Feb. 6 - MediciNova, Inc. announced Monday the completion of enrollment of 297 patients with relapsing multiple sclerosis in its phase 2 clinical trial of MN-166.

MN-166 is a novel, orally administered compound being evaluated for the treatment of multiple sclerosis, officials said in a company news release.

In July 2005, MediciNova began a randomized, double-blind, placebo-controlled multi-center phase 2 clinical trial of MN-166 in multiple sclerosis patients in Eastern Europe.

In this trial, 297 patients have been randomized to receive a placebo or one of two doses of MN-166, officials said.

Efficacy data is expected after one year of treatment in the first quarter of 2007.

MN-166 inhibits leukotriene activity, phosphodiesterases and nitric oxide synthase, all inflammatory mechanisms known to be involved in multiple sclerosis, officials said.

Recently, MN-166 was found to have beneficial effects in several pilot clinical trials conducted in multiple sclerosis patients in Japan.

These findings led to the issuance of a new U.S. method-of-use patent for MN-166 in 2002.

"MN-166 may be an effective new approach to treating multiple sclerosis with the added advantage of oral dosing. Rapid completion of enrollment in this relatively large trial demonstrates our commitment to advancing our clinical programs efficiently though the phase 2 proof-of-concept stage and beyond," Yuichi Iwaki, executive chairman and acting chief executive officer of MediciNova, said in the release.

MediciNova acquired the rights to MN-166 from Kyorin Pharmaceutical Co. Ltd. for global markets excluding Japan, China, Taiwan and South Korea.

For the past 16 years, MN-166 has been marketed in Japan and South Korea as Ketas for the treatment of asthma and cerebrovascular disorders.

Data from the existing clinical trial and post-marketing surveillance databases, which includes treatment of an estimated 3.2 million patients with these disorders, indicate that Ketas is well-tolerated, officials said.

MediciNova is a San Diego specialty pharmaceutical company involved in development and commercialization of pharmaceutical products with a focus on cancer, asthma, anxiety disorder, multiple sclerosis, interstitial cystitis, preterm labor and urinary incontinence.

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