SAN DIEGO, Aug. 10, 2011 (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 (Code Number: 4875), disclosed a clinical trial collaboration with Paul Rolan, M.D., FRACP. Professor Rolan is a headache and pain specialist in the Clinical Pharmacology department at the University of Adelaide, Australia, and is initiating a Phase 2 trial of ibudilast (MN-166/AV411) as a potential new pharmacotherapy for medication overuse headache (MOH). He previously collaborated with MediciNova's subsidiary, Avigen, in a Phase 1b/2a trial of ibudilast in chronic neuropathic pain. The Investigator-initiated (and Investigator-funded) MOH trial has cleared necessary reviews and MediciNova will provide regulatory support and active drug and placebo product for the trial.
Medication overuse headache is a chronic condition, is the third most common form of headache, following tension-type headache and migraine, and is estimated to affect 1-2% of the general adult population. The basis for considering ibudilast in MOH is founded upon the premise that MOH derives from a cumulative effect of over-activation of brain and spinal cord pain-sensing pathways and activation of glial cells in the brain by opioid analgesics such as codeine. Ibudilast is a well-recognized attenuator of glial cell activation and has additionally been shown in clinical studies to modify opioid analgesic and withdrawal phenomena.
"Of all the patients that I see with chronic headache, medication overuse headache represents the greatest combination of frequency and burden. We have few evidence-based treatments for this condition, and unlike ibudilast, most of the drugs I would try have significant cognitive and sedative adverse effects. This novel approach being tested in the trial applies current state of the art knowledge of the role of glia in chronic pain to address an unmet medical need. A key part of obtaining the necessary ethical and regulatory clearances has been critical information supplied by MediciNova," said Prof. Rolan. "Participation in this clinical trial is a natural follow-on of prior leading-edge collaborative preclinical and clinical research with Prof. Rolan and University of Adelaide colleagues for new pain utilities for ibudilast," noted Kirk Johnson, Ph.D., Chief Scientific Officer, MediciNova.
The Phase 2 study is double-blind involving at least 40 patients, randomized 1:1 to placebo or 80 mg/day ibudilast (as the delayed-release PinatosR capsule format of MN-166) for 8 weeks. The study will include headache surveys, quantitative sensory testing (QST), and plasma and blood cell biomarkers. Headache endpoints will additionally be assessed at 6 months post-therapy onset.
"Due to the novel mechanism of action of ibudilast as a macrophage migration inhibitory factor (MIF) and phosphodiesterase (PDE) inhibitor, study outcomes may yield new clinical applications for this perplexing and disabling condition as well as mechanistic insights to the syndrome," noted Yuichi Iwaki, M.D., Ph.D., President and CEO of MediciNova.
About Ibudilast
Ibudilast has been used in asthma and post-stroke disorders in Japan for nearly 20 years. MediciNova has recognized 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 between drug addiction investigators at organizations like Columbia/NYSPI and UCLA has led to National Institute on Drug Abuse, or NIDA-supported pre-clinical and clinical investigations with ibudilast for both opioid and methamphetamine addiction. Our priorities include support of the drug addiction indications and, pursuant to funding, implementation of Phase 2 proof-of-concept trials in Progressive MS and 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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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.