Data From MediciNova's Two-Year Phase II Clinical Trial of MN-166 in Multiple Sclerosis Presented At the World Congress for Treatment and Research in MS (WCTRIMS)

La Jolla, California, UNITED STATES

SAN DIEGO, Sept. 18, 2008 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market (Nasdaq:MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number: 4875), today announced that data from the completed two-year Phase II clinical trial of orally administered MN-166 for the treatment of multiple sclerosis (MS) was presented today in two poster presentations at the World Congress for Treatment and Research in MS being held in Montreal, Canada.

The first presentation entitled "Clinical Effect of the Neuroprotectant MN-166 in Relapsing Forms of MS: Year 2 Data" (Poster 48), given by Dr. Richard Gammans, Chief Development Officer of MediciNova, reported that MN-166 treatment resulted in positive findings on three independent measures indicative of a potential disease-progression modifying effect. The poster can be accessed at: The findings include:

 * Sustained disability progression was significantly less likely (by
   approximately 50 percent) in those patients receiving MN-166 at
   either 30 or 60 mg per day for 24 months than in those patients
   receiving the drug for 12 months (p=0.026).  Sustained disability
   progression was measured as a greater than or equal to 1.0 point
   increase from baseline in the Expanded Disability Status Scale
   (EDSS) score for four consecutive months. This positive clinical
   finding was corroborated by positive findings on two separate
   radiologic measures.

 * The Phase II clinical trial demonstrated that the significant
   reduction in brain volume loss (p=0.035), as measured by cranial
   magnetic resonance imaging (MRI) scans, observed after 12 months
   in patients treated with 60 mg per day of MN-166 compared to
   placebo was again demonstrated in year two of the study. Brain
   volume loss was significantly less (p=0.030) in patients who
   received 60 mg per day of MN-166 for 24 months compared to the
   other treatment groups.

The second presentation entitled "Ibudilast Reduces Conversion of New Inflammatory Lesions to Persistent Black Holes in Active Relapsing Multiple Sclerosis" (Poster 271), given by Dr. Hanneke Hulst of VU University Medical Center, Amsterdam, The Netherlands, reported that the Phase II data demonstrated that MN-166 treatment resulted in positive findings on independent MRI measures indicative of a neuroprotective effect. The findings include:

 * MN-166 treatment at 60 mg per day significantly reduced the
   relative risk for conversion of new inflammatory lesions identified
   at month two to Persistent Black Holes (PBH), an MRI indicator of
   neuronal loss, eight months later at month ten by 37 percent
   (p=0.011); such lesions that remain unchanged for eight months are
   considered PBHs as compared to transient inflammatory lesions that
   are more closely associated with relapses.  MN-166 treatment at 30
   mg per day resulted in a trend toward reducing evolution to PBH
   (p=0.074).  Loss of brain volume and development of PBHs on MRI
   have been shown to correlate with clinical progression and
   disability in MS patients.

"We are pleased that the WCTRIMS Scientific Program Committee accepted two presentations on different aspects of the results from our recently completed Phase II clinical trial of MN-166," said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc. "The significant favorable effects on measures of disability progression and reduced neuronal damage observed in the study, as described in these presentations, are quite exciting and representative of the type of new treatment being sought by the MS scientific community according to our advisors. We are excited to be part of advancing MS treatment in a new direction and look forward to confirming these findings in future clinical trials with the assistance of a corporate partner."

The two-year randomized, double-blind, placebo-controlled Phase II clinical trial included 297 patients with relapsing MS. In the second year of the study, all patients were on drug. Patients who received 30 or 60 mg of MN-166 per day during the first 12 months of the study remained on the assigned dose for the second 12 months of the study; patients who received placebo during the first 12 months of the study were randomized to receive either 30 or 60 mg of MN-166 per day (double-blind maintained) during the second 12 months of the study. Clinical and radiological outcomes were evaluated.

MN-166 was well tolerated at all doses over the 24 months of this Phase II clinical trial. Of the 297 patients enrolled in the study, 82.5 percent, or 245 patients, completed the full 24 months of the study. The most common adverse events possibly related to MN-166 included mild, transient gastrointestinal disturbances and depression.

First-year efficacy results of this clinical trial were announced in March 2007 and described more completely at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in November 2007. Clinical results from the completed two-year clinical trial were announced in April 2008.

About MN-166

MN-166 is a novel, orally administered compound being evaluated for the treatment of MS. MN-166 increases the release of neuronal growth factors and inhibits leukotriene activity, phosphodiesterases and nitric oxide synthase. MN-166 may also suppress the production of pro-inflammatory cytokines (IL-1beta, TNF-alpha) and may enhance the production of the anti-inflammatory cytokines (IL-4, IL-10).

MediciNova acquired an exclusive, worldwide (excluding Japan, China, Taiwan and South Korea), sublicensable license to MN-166 for the treatment of MS, excluding ophthalmic solution formulations, from Kyorin Pharmaceutical Co. Ltd. For the past 18 years, MN-166 has been marketed in Japan and South Korea as Ketas(r) 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(r) is well tolerated.

About MediciNova

MediciNova, Inc. is a publicly-traded biopharmaceutical company focused on acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet need with a specific focus on the U.S. market. Through strategic alliances primarily with Japanese pharmaceutical companies, MediciNova holds rights to a diversified portfolio of clinical and preclinical product candidates, each of which MediciNova believes has a well-characterized and differentiated therapeutic profile, attractive commercial potential and patent assets having claims of commercially adequate scope. MediciNova's pipeline includes six clinical-stage compounds for the treatment of acute exacerbations of asthma, multiple sclerosis, asthma, interstitial cystitis, solid tumor cancers, Generalized Anxiety Disorder, preterm labor and urinary incontinence and two preclinical-stage compounds for the treatment of thrombotic disorders. MediciNova's current strategy is to focus its resources on the development and commercialization of two prioritized assets in its development pipeline: MN-221 for the treatment of acute exacerbations of asthma and MN-166 for the treatment of multiple sclerosis. MediciNova will seek to monetize its other product candidates at key value inflection points. For more information on MediciNova, Inc., please visit

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