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New Lesions at Month 2 72 64 56 # Patients w. = 1 PBH (% of Pts. w. New Lesions) 41 (56.9%) 33 (51.6%) 28 (50%) Mean Proportion of Lesions Evolving to PBH 0.24 0.20 0.16 Median Proportion of Lesions Evolving to PBH 0.17 0.08 0.04 Relative Risk (for Evolution to PBH) vs. placebo 0.74 0.63 p Value 0.074 0.011 New T1 gadolinium enhancing or new T2 lesions were defined as NL in the first on study MRI at month 2 Lesions that were hypointense and inactive at month 10 were PBH Relative Risk (RR) of NL evolution to PBH was analyzed using a general linear model with the error term from the Poisson distribution Reduction of Persistent Black Hole Reduction of Persistent Black Hole (PBH) Formation (PBH) Formation MediciNova, Inc. 2008 MN 166 had no effect on RL lesion evolution as defined in this study MN 166 treatment reduced the Relative Risk that a new inflammatory lesion would evolve to a PBH At 60 mg/d the RR was reduced to 0.63, a 37% reduction, p=0.011 At 30 mg/d the RR was reduced to 0.74, a 26% reduction, p=0.074 Summary Summary MediciNova, Inc. 2008 The findings of this investigation suggest that the main effect of MN 166 treatment in Relapsing MS patients is to protect neurons from the persistent damage that results form inflammatory lesions Further study of the effect of MN 166 on sustained disability progression including markers of neuroprotection is warranted Conclusions Conclusions
New Lesions at Month 2 72 64 56 # Patients with = 1 Recovering Lesion 42 (58.3%) 40 (62.5%) 34 (60.7%) Mean Proportion of Recovering Lesions 0.24 0.28 0.26 Median Proportion of Recovering Lesions 0.20 0.23 0.22 Relative Risk (for Recovering Lesion Rates) vs. placebo 1.135 0.970 p Value 0.376 0.836 New T1 gadolinium enhancing or new T2 lesions were defined as NL in the first on study MRI at month 2 Hypointense lesions at month 2 or 4 that were isointense at month 10 were RL Relative Risk (RR) of NL evolution to PBH and RL per patient was analyzed using a general linear model with the error term from the Poisson distribution Assessment of Recovering Lesions Assessment of Recovering Lesions MediciNova, Inc. 2008 T1 with gadolinium Visit 4 T1 without gadolinium Visit 4 T1 without gadolinium Visit 5 T1 without gadolinium Visit 8 Month 4 Month 2 Month 10 Persistent Black Hole Persistent Black Hole Axonal Loss Axonal Loss MediciNova, Inc. 2008 Parameter Treatment Groups Placebo 30 mg/day 60 mg/day # Patients w.
Milanov MD PhD DSci Ekaterina Titianova MD PhD Study conduct Accelsiors, Budapest Hungry Image Analysis Center, VU Medial Center, Amsterdam Netherlands Institute for Laboratory Medicine, Clinical University of Leipzig, Germany eRT Inc, Philadelphia PA USA MDSL, Maidenhead UK Sponsor MediciNova Inc, San Diego CA USA MN 166 CL 001 Investigators MN 166 CL 001 Investigators MediciNova, Inc. 2008 Neuroprotective Inhibits nitric oxide and reactive oxygen species production Stimulates neurotrophic factor release (NGF, GDNF, NT 4) Cerebrovasodilator (via PGI 2 and/or adenosine receptors) Anti inflammatory Phosphodiesterase 3A, 4, 10, 11 inhibitor Leukotriene inhibitor Inhibits Th1 cytokine production (IFN , TNF , IL 1 , IL 6) Stimulates Th2 cytokine production (IL 4, IL 10) MN 166 (ibudilast) MN 166 (ibudilast) Mechanism(s) of Action Mechanism(s) of Action MediciNova, Inc. 2008 297 RMS Patients Randomized 967 Patients Screened Placebo N=100 30 mg/d N=94 60 mg/d N=98 30 mg/d 30 mg/d 60 mg/d 60 mg/d 0 12 Month 12 24 Month Primary endpoint : cumulative active lesions by MRI Secondary endpoints: clinical relapses and other MRI measures MN 166 CL 001 Scheme MN 166 CL 001 Scheme (MRI and Clinical evaluations bi monthly) (MRI and Clinical evaluations bi monthly) MediciNova, Inc. 2008 MN 166 was well tolerated at doses up to 60 mg/d MN 166 treatment at a dose of 60 mg/d did not significantly reduce Cumulative Lesion Count ( 18%, NS), the Primary Study Endpoint MN 166 treatment at a dose 60 mg/d significantly prolonged time to first relapse (median =401) by 157 d vs. placebo (median =401, p=0.04) MN 166 treatment at a dose 60 mg/d significantly attenuated brain volume shrinkage ( 34%, p=0.03) Sustained disability progression (EDSS increase 1 for 4 mo) on MN 166 60 mg/d was less (4%) than on Placebo (8%, NS) Main Year 1 Study Findings Main Year 1 Study Findings (ECTRIMS 2007) (ECTRIMS 2007) MediciNova, Inc. 2008 Hypothesis: Based on its modest effect on inflammatory lesion count, its pharmacology, attenuating brain volume loss, and early trend to reduce sustained disability progression we hypothesized that MN 166 s clinical benefit at 60 mg/d may result primarily from protecting neurons from damage rather than reducing occurrence of inflammatory lesions Objective: To measure the effect of MN 166 on evolution of inflammatory lesions to recovered lesions or persistent black holes, MRI measures of neuroprotection, in formal retrospective study of MRIs collected during year 1 of the MN 166 CL 001 study Hypothesis and Objective Hypothesis and Objective MediciNova, Inc. 2008 Blinded MRI data from year 1 was evaluated by a new rater not previously involved in the study New T1 gadolinium enhancing or new T2 lesions were identified as NL (new lesions) in the first on study drug MRI at month 2 These lesions were then followed in the month 4 and 10 MRI, and classified as PBH or RL by pre defined criteria: PBH = Lesions that were hypointense and inactive at month 10 RL = Hypointense lesions at month 2 or 4 that were isointense at month 10 The relative risk of NL in month 2 evolving to RL or PBH per patient was analyzed (Note: lesions within a patient are assumed not to be independent) Methods Methods Evolution of new lesions to Persistent Black Holes Evolution of new lesions to Persistent Black Holes (PBH) or Recovered Lesions (RL) (PBH) or Recovered Lesions (RL) MediciNova, Inc. 2008 T1 with gadolinium Visit 4 T1 without gadolinium Visit 4 T1 without gadolinium Visit 5 T1 without gadolinium Visit 8 Month 2 Month 10 Month 4 Example of RL (red box) Example of RL (red box) MediciNova, Inc. 2008 Parameter Treatment Groups Placebo 30 mg/day 60 mg/day # Patients w.
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. Forward Looking Statements Forward Looking Statements MediciNova, Inc. 2008 Serbia Congor Nad, MD PhD Slobodan Vojinovic, MD PhD Evica Dincic, MD PhD Jelena Drulovic, MD PhD Branislava Mr ulja, MD PhD Vladimir Bojovic, MD PhD Gordana Toncev, MD PhD Jagoda Potic, MD Romania Dan Minea, MD PhD Byelorussia Ponomarev Vladimirovich, MD PhD Ukraine Kostyantyn Loganovskyy Mykolayovich, DMN Bulgaria Penko Shotekov, MD Dsci Lyubomir Haralanov, MD PhD Ivan G.
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MediciNova, Inc. 2008 MN 166 Reduces Conversion of New Lesions to Persistent Black Holes in Multiple Sclerosis Patients R. Gammans PhD, F. Barkof MD PhD, H. Hulst MD, R. Landin PhD for the MN 166 CL 001 investigators Exhibit 99.1 MediciNova, Inc. 2008 Statements in this presentation 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.