MediciNova and University of Colorado Boulder Collaborate on Potential Novel Therapy for Traumatic Brain Injury


SAN DIEGO, Jan. 16, 2012 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market (Nasdaq:MNOV) and the Jasdaq Market of the Osaka Securities Exchange (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."

About Ibudilast

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. 

About MediciNova

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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About University of Colorado

The CU Technology Transfer Office pursues, protects, packages, and licenses to business the intellectual property generated from research at CU. The TTO provides assistance to faculty, staff, and students, as well as to businesses looking to license or invest in CU technology. For more information about technology transfer at CU, visit www.cu.edu/techtransfer.

The University of Colorado is a premier public research university with four campuses: the University of Colorado Boulder, the University of Colorado Colorado Springs, the University of Colorado Denver and the University of Colorado Anschutz Medical Campus. Some 60,000 students are pursuing CU academic degrees. Academic prestige is marked by the university's four Nobel laureates, seven MacArthur "genius" Fellows, 18 alumni astronauts and 19 Rhodes Scholars. For more information, go to www.cu.edu.

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 our portfolio of clinical and preclinical product candidates and statements regarding the proposed study of ibudilast for medication overuse headache and the potential utility of ibudilast as a treatment for neurological disorders. These forward-looking statements may be preceded by, followed by or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "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, 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, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, 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 regulatory authorities, 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, 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, 2010 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.



            

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