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LONDON, UK / ACCESSWIRE / February 05, 2018 / Active-Investors.com has just released a free research report on MediciNova, Inc. (NASDAQ: MNOV). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=MNOV as the Company's latest news hit the wire. On February 01, 2018, the Company, a biopharmaceutical organization with a primary commercial focus on the US market, declared the presentation of additional positive clinical data from the SPRINT-MS Phase-2b Trial of MN-166 (ibudilast) in progressive multiple sclerosis (progressive MS), which was conducted through the National Institutes of Health (NIH)-sponsored NeuroNEXT network. In the study, MN-166 exhibited a 26% reduction in the risk of confirmed disability progression compared to placebo (hazard ratio = 0.74), as measured by the Expanded Disability Status Scale (EDSS). Register today and get access to over 1000 Free Research Reports by joining our site below:

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Active-Investors.com is currently working on the research report for Pacific Biosciences of California, Inc. (NASDAQ: PACB), which also belongs to the Healthcare sector as the Company MediciNova. Do not miss out and become a member today for free to access this upcoming report at:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, MediciNova most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

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Dr. Robert Naismith, Associate Professor of Neurology at Washington University School of Medicine and an investigator of the SPRINT-MS trial, presented the data at the Americas Committee for Treatment and Research in MS (ACTRIMS) Forum in San Diego, California, on February 01, 2018 at 6:00 p.m. ? 8:00 p.m.

Progressive MS, A Severe Disability

The National MS Society estimates that MS affects approximately 2.3 million people worldwide. Of these, 85% are originally diagnosed with relapsing remitting MS (RRMS) and the majority of the RRMS patients eventually transition into SPMS, wherein there are fewer relapses but gradual worsening of neurologic function.

Around 15% of MS patients are diagnosed with PPMS at onset. As a result, they show gradually increasing disability in walking, vision, mental acuity, and other bodily functions without experiencing relapses or remissions. The existing therapies for MS affect the inflammatory response but provide limited relief for the neuro-degeneration seen in progressive MS. Thus, there is considerable medical need for agents that could offer neuro-protection in progressive MS.

Treating Neurological Conditions with MN-166

MediciNova is developing MN-166 for progressive MS and other neurological conditions such as ALS and substance abuse/addiction. It is basically a first-in-class, orally bio-available, small molecule phosphodiesterase (PDE) inhibitor (-4 and -10), and a macrophage migration inhibitory factor (MIF) inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. It weakens activated glia cells, which play a major role in certain neurological conditions. The anti-neuroinflammatory and neuro-protective actions of MN-166 justify its therapeutic utility in neuro-degenerative diseases (e.g., progressive MS and ALS), substance abuse/addiction, and chronic neuropathic pain.

The Progressive MS Trial

The Phase-2b Secondary and Primary Progressive Ibudilast NeuroNEXT trial in Multiple Sclerosis (SPRINT-MS) was specifically designed to evaluate the safety, tolerability, and activity of MN-166, which was administered orally twice daily to subjects with primary progressive or secondary progressive multiple sclerosis (PPMS or SPMS, respectively). The Study had 28 enrolling clinical sites across the US and a total of 255 qualifying subjects were randomly assigned 1:1 to inactive control (placebo) or MN-166 (ibudilast) administered at a dose of up to 100 mg/day (50 mg twice daily). The progressive MS subjects were either untreated with long-term disease modifying therapy (DMT) or continued on either glatiramer acetate (GA) or interferon beta (IFN?-1a or IFN?-1b) treatment. As a result, randomization was controlled by two factors: therapy status (IFN/GA vs. no DMT) and disease status (PPMS vs. SPMS). The primary objectives of the study were to:

  • Assess the performance of MN-166 versus placebo at 96 weeks as measured by quantitative magnetic resonance imaging (MRI) analysis for whole brain atrophy using brain parenchymal fraction (BPF), and
  • Assess the safety and tolerability of MN-166 versus placebo in subjects with PPMS or SPMS.

Secondary measures include disability, imaging analyses of brain and retinal tissue integrity, cortical atrophy, cognitive impairment, quality-of-life, and neuropathic pain, while the exploratory objectives include pharmacokinetic and biomarker analyses.

A Collaborative Effort

NIH National Institute of Neurological Diseases and Stroke (NINDS)'s Network for Excellence in Neuroscience Clinical Trials, or NeuroNEXT, was created to conduct studies of treatments for neurological diseases through partnerships with academia, private foundations, and industry.

The NeuroNEXT network conducted the SPRINT-MS study, with funding from the NINDS, the National Multiple Sclerosis Society, and MediciNova.

Both Primary Endpoints Achieved

In-line with MediciNova's announcement in October 2017, the SPRINT-MS Phase-2b Trial of MN-166 (ibudilast) in progressive MS achieved both its primary endpoints.

  • MN-166 showed a statistically significant 48% reduction in the rate of progression of whole brain atrophy compared to placebo (p=0.04). This was measured by MRI analysis using BPF.
  • MN-166 exhibited a favorable safety and tolerability profile. MN-166 did not have an increased rate of serious adverse events, in comparison to the placebo group. That is, there were no opportunistic infections, no cancers, no cardiovascular events, and no deaths related to MN-166 treatment. Also, there was no statistically significant difference in tolerability between the MN-166 and placebo. In fact, the most common treatment-emergent adverse events in the study were gastro-intestinal adverse events, which were observed in a higher frequency in the MN-166 group. On the other hand, upper respiratory tract infections occurred more in the placebo group.

The confirmed disability progression, which was a secondary endpoint in this Phase-2b trial, would now be taken as the primary endpoint in the Phase-3 trial. On the basis of the positive results from the Phase-2b trial, MediciNova expects that the Phase-3 trial of MN-166, which will enroll approximately 700 subjects, will be adequately powered to achieve statistical significance for confirmed disability progression.

Yuichi Iwaki, MD, PhD, President and Chief Executive Officer (CEO) of MediciNova expressed his pleasure on the positive results. The magnitude of reduction in disability progression reported for MN-166 was better than the data reported for the only drug approved for progressive MS and also better than the data reported for the other drugs being developed for progressive MS. Thus, he believes that the drug is well-positioned to become the best-in-disease drug. The Company intends to get formal feedback from the US Food and Drug Administration (FDA) so that it can proceed with this program.

Stock Performance Snapshot

February 02, 2018 - At Friday's closing bell, MediciNova's stock fell 1.04%, ending the trading session at $9.52.

Volume traded for the day: 256.83 thousand shares, which was above the 3-month average volume of 90.51 thousand shares.

Stock performance in the last month ? up 43.81%; previous three-month period ? up 48.75%; past twelve-month period ? up 57.62%; and year-to-date - up 47.14%

After last Friday's close, MediciNova's market cap was at $347.29 million.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry.

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