San Diego, Calif., January 16, 2012 – MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market (Trading Symbol: MNOV) and the Jasdaq Market of the Osaka Securities Exchange (Code Number: 4875), and the University of Colorado (CU) Boulder disclosed a license agreement for the use of ibudilast (MN-166/AV411) for the treatment of post-traumatic brain injury (TBI). Led by the research of Daniel Barth, Ph.D., Professor of Neuroscience and Psychology at CU-Boulder, ibudilast demonstrated significant efficacy in a model of post-TBI anxiety, one of the most common disorders caused by TBI.
Dr. Barth and colleague, Krista Rodgers, discovered that a short course of systemic ibudilast administered over a month after concussion injury reversed post-TBI anxiety in rats for a 3 month measurement period following treatment. “While we had initially observed impressive reduction of anxiety behavior when ibudilast was administered just prior to head injury, we were, frankly, surprised that a few days of treatment so long after injury could provide notable efficacy for up to three months thereafter. This finding suggests that post-traumatic anxiety in humans may have a strong physiological basis in neuro-inflammation and that the ongoing neuropathy may be treatable with drugs like ibudilast that attenuate and perhaps interrupt the brain’s inflammatory response,” commented Dr. Barth.
Traumatic brain injury (TBI) is a major public health concern, with approximately 1.7 million people in the United States alone sustaining a TBI each year. The long-term consequences of TBI include neuropsychiatric disorders, of which anxiety disorders are the most prevalent. Little is known about the neural mechanisms of post-traumatic stress disorders (PTSD) including anxiety and effective pharmacotherapy options for individuals suffering such a disorder are limited. Dr. Barth and colleagues have hypothesized that unchecked activation of glial cells in the brain may contribute to some of the post-TBI disorders. Ibudilast is a selective inhibitor of macrophage-migration inhibitory factor (MIF) and certain phosphodiesterases with well-recognized activity as an attenuator of glial cell activation.
MediciNova is developing ibudilast (MN-166) for several neurological disorders. Recognizing both the unmet need and potential strategic fit with the University of Colorado, Yuichi Iwaki, M.D., Ph.D., President and CEO of MediciNova commented, “we are excited to participate in research aimed at better understanding the traumatic brain injury disease process and in further exploring the potential for MN-166 as a pharmacotherapy.”
Ibudilast has been used in asthma and post-stroke disorders in Japan for around 20 years. MediciNova has demonstrated utility of ibudilast in neurological disorders at higher doses with encouraging outcomes in company-sponsored clinical trials in multiple sclerosis (MS) and neuropathic pain. Collaborative trial planning with drug addiction investigators at organizations like Columbia/NYSPI and UCLA has led to National Institute on Drug Abuse (NIDA)-supported clinical investigations with ibudilast for both opioid and methamphetamine addiction. An investigator-sponsored trial in chronic medication overuse headache (MOH) pain is also ongoing in Australia. Corporate priorities include implementation of Phase 2 proof-of-concept trials in Progressive MS and/or Neuropathic Pain.
MediciNova, Inc. is a publicly traded biopharmaceutical company founded upon acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet need with a commercial 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 coverage of commercially adequate scope. MediciNova’s pipeline includes six clinical-stage compounds for the treatment of acute exacerbations of asthma, chronic obstructive pulmonary disease exacerbations, multiple sclerosis and other neurologic conditions, 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 on its two prioritized product candidates, MN-221, for the treatment of acute exacerbations of asthma and chronic obstructive pulmonary disease exacerbations, and Ibudilast (MN-166/AV411). Each drug candidate is involved in clinical trials under U.S. and Investigator INDs. MediciNova is engaged in strategic partnering discussions to support further development of the MN-221 and Ibudilast programs. Additionally, MediciNova will seek to monetize opportunistically its other pipeline candidates. For more information on MediciNova, Inc., please visit www.medicinova.com.
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