SAN DIEGO, Dec. 18, 2006 (PRIME NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company that is publicly traded on NASDAQ (Nasdaq:MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number: 4875), today announced the initiation of the Phase II clinical program to determine the safety and efficacy of MN-221, its novel intravenous product candidate for status asthmaticus. Status asthmaticus is an acute, long-lasting and severe asthma episode that does not respond to initial standard treatments and is potentially fatal.
MN-221 is highly-selective Beta2-adrenergic receptor agonist under development by MediciNova for the treatment of status asthmaticus. Preclinical testing in vitro and in vivo shows MN-221 to be more selective for the Beta2-adrenergic receptor than other Beta2-adrenergic receptor agonists used to treat status asthmaticus. This improved selectivity may result in fewer cardiovascular side effects than are commonly observed with these other agents. Importantly, MediciNova has developed an intravenous formulation of MN-221 that may effectively bypass the constricted airways in status asthmaticus to deliver effective concentrations of the drug to the lungs. The first Phase II trial in the status asthmaticus program will involve 28 mild-to-moderate asthma patients who will receive a 15-minute intravenous infusion of MN-221 or placebo in this randomized, placebo-controlled, dose-escalating crossover-design study. The primary endpoint of the trial will be the change from baseline in mean FEV1 (forced expiratory volume in 1 second) after a 15-minute infusion of MN-221.
"MN-221 represents a potential paradigm-changing treatment for status asthmaticus," said Yuichi Iwaki, M.D., Ph.D., Executive Chairman and CEO of MediciNova, Inc. "We are committed to developing compounds such as MN-221 that we hope will fill significant unmet medical needs for large underserved markets."
MediciNova acquired a license to MN-221 from Kissei Pharmaceutical Co., Ltd. for global markets excluding Japan. The intellectual property acquired from Kissei included extensive preclinical and clinical safety data. MN-221 is also under development by MediciNova for the treatment of preterm labor.
About Status Asthmaticus
Status asthmaticus is a long-lasting and severe asthma episode in which asthma symptoms are not responsive to initial bronchodilator or corticosteroid therapy. Status asthmaticus is an emergency situation that can lead to emergency department treatment, hospitalization and in some cases death. Beta-adrenergic receptor agonists (e.g., albuterol) are the mainstays of acute treatment for these attacks. However, there may be too little airflow for adequate delivery of these agents via the standard inhaled or nebulized routes of administration. According to the National Center for Health Statistics, there were 1.9 million emergency room visits, nearly 500,000 hospitalizations and over 4,000 deaths due to asthma in 2004. Thus, there remains a significant unmet medical need for a safe and effective treatment of this condition.
About MediciNova
MediciNova, Inc. is a publicly-traded biopharmaceutical company focused on accelerating the global development and commercialization of innovative pharmaceutical products. MediciNova's pipeline, which includes six compounds in clinical testing, targets a variety of prevalent medical conditions, including asthma, multiple sclerosis, status asthmaticus, interstitial cystitis, cancer, Generalized Anxiety Disorder, insomnia, preterm labor, urinary incontinence and thrombotic disorders. For more information on MediciNova, Inc., please visit www.medicinova.com.
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This press release may contain "forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include statements regarding clinical trials supporting efficacy of one of our product candidates as well as the potential novelty of that candidate as a treatment for disease. These statements are based on certain assumptions made by the Company's management that are believed to be reasonable at the time. Such statements are subject to a number of risks and uncertainties, many of which are beyond the control of the Company, including the results of clinical studies and other risks and uncertainties, including those described in the Company's filings with the Securities and Exchange Commission. These assumptions, risks and uncertainties could cause the Company's actual results to differ materially from those implied or expressed by the forward-looking statements.