Showing posts with label MN-166. Show all posts
Showing posts with label MN-166. Show all posts

Wednesday, October 01, 2008

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





SAN DIEGO, Sep 18, 2008 (GlobeNewswire via COMTEX News Network) -- 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: http://www.medicinova.com/MN-166-Relapsing-MS.html. 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 www.medicinova.com.

The MediciNova, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3135

Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding MediciNova's clinical trials supporting safety and efficacy of product candidates and the potential novelty of such product candidates as treatments for disease, plans and objectives for present and future clinical trials and product development, strategies, future performance, expectations, assumptions, financial condition, liquidity and capital resources. These forward-looking statements may be preceded by, followed by or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "would," or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements, include, but are not limited to, the risks and uncertainties inherent in clinical trials and product development and commercialization, such as the uncertainty in results of clinical trials for product candidates, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials and the timing, cost and design of future clinical trials and research activities, the timing of expected filings with the FDA, MediciNova's failure to execute strategic plans or strategies successfully, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to raise sufficient capital when needed, intellectual property or contract rights, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2007 and its subsequent periodic reports on Forms 10-Q and 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

This news release was distributed by GlobeNewswire, www.globenewswire.com

SOURCE: MediciNova, Inc.

MediciNova, Inc.
Shintaro Asako, Chief Financial Officer
858-373-1500
info@medicinova.com

Rx Communications, LLC
Rhonda Chiger
(917) 322-2569
rchiger@rxir.com

Wednesday, April 09, 2008

MediciNova Reports Clinical Results from





- MN-166 Slows Disability Progression; Significant Neuroprotective Effects Observed by MRI -

SAN DIEGO, Calif. – April 7, 2008 – MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market (Trading Symbol: MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number: 4875), today
announced positive clinical findings from the completed two-year Phase II clinical trial of orally administered MN-166 for the treatment of multiple sclerosis (MS). The second year findings expand upon the results from the first year of this study reported previously. MN-166 treatment resulted in positive findings on three independent measures indicative of a potential disease-progression modifying effect. 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 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 receiving 60 mg per day of MN-166 for 24 months compared to the other treatment groups, for more information on Percent Brain Volume loss for each of the treatment groups in year two of the study, see graph:

PERCENT BRAIN VOLUME LOSS AT 24-MONTHS





• 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. MN-166 was well tolerated at all doses over the 24 months of this 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.

“After an extensive review of these data our Scientific Advisory Board recommended that MN-166 be advanced into pivotal design studies with clinical and MRI evaluations of MS progression as the primary objectives,” 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 this study 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. 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. Briefly, MN-166 at 60 mg per day significantly reduced brain volume loss by 33 percent and median time to first relapse by 157 days compared to placebo. The median time to first on-study relapse was 244 days for placebo, 255 days on MN-166 at 30 mg per day and 401 days (which could only be calculated after the full study unblinding) on MN-166 at 60 mg per day. MN-166 did not significantly reduce cumulative brain lesion count on MRI in year one of this clinical trial, which was the protocol-defined primary endpoint of the study.

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-1β, TNF-α) 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® for the treatment of asthma and cerebrovascular disorders. Data from the existing clinical trial and postmarketing surveillance databases, which includes treatment of an estimated 3.2 million patients with these disorders, indicate that Ketas® 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 status asthmaticus, 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 status
asthmaticus, an acute, severe asthma attack, 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
www.medicinova.com.

Statements in this press release that are not historical in nature constitute forwardlooking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include,
without limitation, statements regarding MediciNova’s clinical trials supporting safety and efficacy of product candidates and the potential novelty of such product candidates as treatments for disease, plans and objectives for present and future clinical trials and product development, strategies, future performance, expectations, assumptions, financial condition, liquidity and capital resources. These forward-looking statements may be preceded by, followed by or otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “estimates,” “projects,” “can,” “could,” “may,” “would,” or similar expressions.

These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forwardlooking statements, include, but are not limited to, the risks and uncertainties inherent in clinical trials and product development and commercialization, such as the uncertainty in results of clinical trials for product candidates, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials and the timing, cost and design of future clinical trials and research activities, the timing of expected filings with the FDA, MediciNova’s failure to execute strategic plans or strategies successfully, MediciNova’s collaborations with third parties, the availability of funds to complete product development plans and MediciNova’s ability to raise sufficient capital when needed, intellectual property or contract rights, and the other risks and uncertainties described in MediciNova’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2007. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

Monday, October 15, 2007

MN-166 (Ibudilast) Shows Efficacy in Relapsing Forms of Multiple Sclerosis: Presented at ECTRIMS





By Chris Berrie PRAGUE, CZECH REPUBLIC -- October 14, 2007 -- The anti-inflammatory and neuroprotective oral agent MN-166 (ibudilast) shows an excellent safety profile at 60 mg/day and provides significantly prolonged time-to-first relapse and attenuated brain volume shrinkage in patients with relapsing-remitting (RR) and/or secondary progressive (SP) multiple sclerosis (MS). Sponsor trial coordinator Richard E. Gammans, PhD, Chief Development Officer, MediciNova Inc., San Diego, California, presented the findings from a multicenter, randomised, double-blind, placebo-controlled, phase 2 study here on October 12 at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). "Pharmacologically, MN-166 has mechanisms that include anti-inflammatory effects, such as phosphodiesterase inhibition, and neuroprotective effects, such as inhibition of [nitric oxide] synthesis and reduction in reactive oxygen species," he said. This study was thus designed to evaluate the effects of MN-166 in patients with MS. The study enrolled patients aged 18 to 55 years who were diagnosed with RRMS or SPMS using McDonald criteria, with continued relapses. They had one or more Gd-enhancing lesion on MRI scan taken 2 weeks before treatment start; and expanded disability status scale (EDSS) no greater than 5.5 at screening. The main exclusion criteria were based around no use of various immunosuppressants within 6 months, or of interferons -- corticosteroids and adrenocorticotropic hormone -- within 45 days of the initial magnetic resonance imaging (MRI) scan. The primary endpoint was cumulative active lesions on MRI. The secondary endpoints were clinical relapse and other MRI measures. Of 967 patients screened, 100 were randomized to placebo, 94 were randomized to 30 mg/day of MN-166, and 96 were randomized to 60 mg/day of MN-166 for the first 12 months of treatment, with clinical and MRI evaluations every 2 months. The 12-months extension phase was designed to evaluate the effects of continuation of MN-166 dosing, with placebo patients switched to MN-166 30 mg/day or 60 mg/day. Baseline clinical characteristics across these three treatment groups were similar for percent RRMS, percent spinal or cerebrum location of lesions, and number of relapses in previous 24 months. There were indications that time since both MS diagnosis and onset of symptoms were longer in the treated groups (39, 50, 60 months; 73, 96, 98 months; respectively). In terms of primary outcome of cumulative active lesions over the first 12 months, there was no significant difference amongst treatments. However, there was a modest difference between the highest dose of MN-166 and placebo, with an 18% reduction in cumulative active lesions, although this difference was not significant, indicated Dr. Gamman. Similarly, there were no significant differences between treatment group in the percent of patients with sustained disability progression on EDSS (8.0%, 5.3%, 4.1%). In contrast, for other MRI assessments over the 12 months, MN-166 at 60 mg/day showed not only a significant improvement in the percentage of brain volume reduction ([P =.035), but also a significant increase in the median time to first relapse (P =.04). Thus, the percentage of patients who were relapse-free at year 1 was significantly greater at the higher MN-166 dose (41% vs 41.5% vs 56.0% (P =.03).

Dr. Gammans said that MN-166 was very well tolerated, with 89% of patients completing the first 12 months of treatment. "The side effects were generally mild, and resolved without intervention, and there were no adverse observations on laboratory or [electrocardiographic] findings as well," he added.

When the two MN-166 treatment groups were combined, gastrointestinal side effects were the only adverse events to occur at 2-fold or greater times those of placebo (7.6% vs 14.7% vs 22.2%), although tolerance to these effects occurred rapidly (2-4 days). There were no deaths in the study.

Due to these modest effects of MN-166 on inflammatory lesion counts and based on its pharmacology, Dr. Gamman said that the clinical benefits of MN-166 60 mg/day arise primarily from its actions towards protection of neurons from damage, rather than towards reduction of inflammatory lesions.

At the same time, the excellent safety profile at 60 mg/day and the effects that reached significance in this study suggest that future studies with MN-166 should evaluate higher doses on disease progression and MRI measures of neuroprotection, rather than inflammation.

Funding for this study was provided by MediciNova Inc.


[Presentation title: Clinical Effect of the Neuroprotectant MN-166 in Relapsing Forms of MS. Abstract 52]

Copyright © 2007 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content.

Tuesday, June 26, 2007

MediciNova Announces New Strategic Initiative





SAN DIEGO, Jun 26, 2007 (PrimeNewswire via COMTEX News Network) -- 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 based on recent clinical successes and evaluation of market opportunities, it will focus its resources on development and commercialization of two key assets in its development pipeline, MN-221 and MN-166. MediciNova believes that MN-221, now in Phase IIa clinical testing, has the potential to become the new standard of care for the treatment of severe, acute exacerbations of asthma (status asthmaticus) in emergency facility settings. Data from the Phase IIa trial is expected during the fourth quarter of 2007. MN-166, an oral treatment for multiple sclerosis, demonstrated positive clinical benefits and a superior safety profile after one year of treatment in a two-year randomized, double-blind, placebo-controlled Phase II trial in 297 relapsing multiple sclerosis patients.

Adhering to its strategy to focus investment on key assets such as MN-221 and MN-166, and in order to bring these assets substantially forward towards commercialization, MediciNova will limit its expenditures on other development programs to only those activities necessary to maximize each asset's value, while aggressively pursuing a variety of initiatives to monetize these development programs. As part of this strategy, MediciNova will discontinue development of MN-001 in its current immediate-release formulation. As such, the current Phase III trial of MN-001 in bronchial asthma patients will be stopped. To date, approximately 200 patients have been enrolled in that trial with no reported serious adverse events. The formulation currently being tested requires a multiple dosing per day schedule. Market and competitive analyses point to the desire for a once-a-day therapy for bronchial asthma and, thus, MediciNova will continue its work on developing a once-a-day preparation of MN-001. MediciNova anticipates that this reallocation of resources will provide substantial cash savings over the next 12 months.

"MediciNova's strategy has always been to select and develop product candidates that fill an unmet medical need and offer competitive market advantages. To that end, we have built an attractive pipeline that provides us with multiple opportunities from which to realize value," said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc. "In focusing our resources, we are in the enviable position to dedicate investment to two commercially attractive development candidates that we can potentially commercialize on our own with a small, focused sales force, while we simultaneously continue efforts to monetize the remainder of our pipeline through business development initiatives, including potential partnering opportunities. We believe this new strategy will provide even greater value in the realization of our key clinical assets."

About MediciNova

MediciNova, Inc. is a publicly-traded biopharmaceutical company that acquires well characterized small-molecule drugs through strategic alliances with Japanese and other international pharmaceutical companies and accelerates their development in a diversified portfolio of therapeutic product candidates targeting significant disease markets. MediciNova's pipeline, which includes six compounds in clinical testing, targets a variety of prevalent medical conditions, including asthma, multiple sclerosis, status asthmaticus, interstitial cystitis, cancer, Generalized Anxiety Disorder, insomnia, preterm labor, urinary incontinence and thrombotic disorders. MediciNova's strategy is to commercialize selected product candidates in the United States and to monetize other programs at key value inflection points. For more information on MediciNova, Inc., please visit www.medicinova.com.

The MediciNova, Inc. logo is available at http://www.primenewswire.com/newsroom/prs/?pkgid=3135

Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding MediciNova's clinical trials supporting efficacy of product candidates and the potential novelty of such product candidates as treatments for disease, plans and objectives for present and future clinical trials and product development, strategies, future performance, expectations, assumptions, financial condition, liquidity and capital resources. These forward-looking statements may be preceded by, followed by or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "would," or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements, include, but are not limited to, the risks and uncertainties inherent in clinical trials and product development and commercialization, such as the uncertainty in results of clinical trials for product candidates, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, MediciNova's reliance on third parties and the timing, cost and design of future clinical trials and research activities, the failure to execute strategic plans or strategies successfully, MediciNova's collaborations with third parties, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2006 and its subsequent periodic reports on Forms 10-Q and 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

This news release was distributed by PrimeNewswire, www.primenewswire.com

SOURCE: MediciNova, Inc.

MediciNova, Inc.
Shintaro Asako, Chief Financial Officer
858-373-1500
info@medicinova.com

Rx Communications, LLC
Rhonda Chiger
(917) 322-2569
rchiger@rxir.com
(C) Copyright 2007 PrimeNewswire, Inc. All rights reserved.

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Tuesday, March 27, 2007

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





Conference Call to Discuss Results On Thursday, March 29, 2007, At 2:00 p.m. Pacific Time

SAN DIEGO, Mar 27, 2007 (PrimeNewswire via COMTEX News Network) -- 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 positive clinical findings from the 12-month core period of a Phase II clinical trial of MN-166 that measures both surrogate (radiological) and clinical outcomes over two years of treatment in 297 patients with relapsing multiple sclerosis (MS).

The randomized, double-blind, placebo-controlled trial showed a significant increase in the proportion of patients who remained relapse-free over the first 12 months of treatment with 60 mg per day of MN-166 compared to placebo (p=0.03). The time to first relapse was also significantly increased in patients treated with 60 mg of MN-166 per day compared to placebo (p=0.04). Positive trends were also observed in the annualized relapse rate (p=0.08) and number of relapses (p=0.10) among patients who completed the full first 12 months of treatment with 60 mg of MN-166 per day compared to those patients completing the first 12 months of treatment on placebo.

A significant reduction in brain volume loss (p=0.04), as measured by cranial magnetic resonance imaging (MRI) scans, was observed in patients treated with 60 mg per day of MN-166 compared to placebo. Loss of brain volume on MRI has been shown to correlate with clinical progression and disability in MS patients. Positive trends were also observed in several other radiological outcome measures, including the volume of gadolinium-enhancing (T1) lesions (p=0.09) in patients treated with 60 mg of MN-166 per day compared with placebo. However, no reduction in the cumulative number of active (gadolinium-enhancing (T1) and non-enhancing new/enlarging (T2)) lesions on cranial 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/enlarging (T2)) cranial MRI lesions (the primary endpoint of the trial) and other MRI-related, exacerbation and disability-related endpoints (relapse rate and Expanded Disability Status Scale (EDSS) score) after 12 months of treatment. Eligible patients who elected to continue their participation in the trial after 12 months of treatment will continue to receive treatment and will be assessed at months 13, 14, 16, 18, 20, 22 and 24 of the trial; patients who received placebo during the first 12 months of the trial were randomized to receive either 30 or 60 mg of MN-166 per day (double-blind maintained) during the second 12 months of the trial.

About Multiple Sclerosis and MN-166

Multiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system (CNS), affecting approximately 250,000 - 350,000 people in the U.S. The most obvious effect of MS is the progressive loss of muscle control, but multiple brain and CNS functions are also affected. There is no cure for the disease. Relapsing-remitting MS (RRMS), which is the most common type of the disease, affects approximately 65% of MS patients according to a Cognos study published by Decision Resources, Inc. Most patients with RRMS eventually progress to the secondary progressive (SPMS) form of the disease.

MN-166 is a novel, orally administered compound being evaluated for the treatment of MS. MN-166 inhibits leukotriene activity, phosphodiesterases and nitric oxide synthase, all inflammatory mechanisms known to be involved in MS. 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). In two pilot clinical trials sponsored by academic investigators in Japan, MN-166 was found to have certain beneficial effects with respect to the treatment of MS.

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 17 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.

Conference Call

Management will discuss the results in a conference call on March 29, 2007 at 2:00 p.m. Pacific Time. The dial-in numbers for the conference call are as follows: 800-479-9001 (Domestic); 719-457-2618 (International).

About MediciNova

MediciNova, Inc. is a publicly-traded biopharmaceutical company that acquires well characterized small-molecule drugs through strategic alliances with Japanese and other international pharmaceutical companies and accelerates their development in a diversified portfolio of therapeutic product candidates targeting significant disease markets. MediciNova's pipeline, which includes six compounds in clinical testing, targets a variety of prevalent medical conditions, including asthma, multiple sclerosis, status asthmaticus, interstitial cystitis, cancer, Generalized Anxiety Disorder, insomnia, preterm labor, urinary incontinence and thrombotic disorders. For more information on MediciNova, Inc., please visit www.medicinova.com.

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Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding MediciNova's clinical trials supporting efficacy of a product candidate and the potential novelty of such product candidate as a treatment for disease, plans and objectives for present and future clinical trials, and plans and objectives for product development. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements, include, but are not limited to, the risks and uncertainties inherent in clinical trials and product development and commercialization, including the results of clinical trials, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, and the timing, cost and design of future clinical trials and research activities, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2006 and its periodic reports on Forms 10-Q and 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

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SOURCE: MediciNova, Inc.

MediciNova, Inc.
Kenneth W. Locke, Ph.D., Chief Business Officer
locke@medicinova.com
Bonnie Feldman, D.D.S., M.B.A., Vice President of
Investor Relations
BFeldman@medicinova.com
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