MediciNova Reports Positive Phase IIa Clinical Study Results for MN-221, a Novel Treatment for Status Asthmaticus
Conference Call Scheduled for Today At 10:00 A.M., Eastern Time
SAN DIEGO, Oct. 9, 2007 (PRIME NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market (Nasdaq:MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number: 4875), today announced positive results from a Phase IIa clinical study of MN-221, its novel intravenous product candidate for the treatment of status asthmaticus (acute severe asthma attack). The study achieved statistical significance in its primary endpoint of mean change in FEV1 (forced expiratory volume in 1 second) from baseline at 15 minutes (the end of the infusion) at doses of 10, 16, 30 and 60 micrograms/min of MN-221 (p less than or equal to 0.0006) compared to placebo. There were no clinically significant cardiovascular, electrocardiogram (ECG), or vital sign changes, nor were there any other safety concerns observed at any dose tested.
"We are extremely pleased and encouraged by the Phase IIa clinical study results and believe that MN-221 has the potential to become a new standard of care for status asthmaticus," said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc. "The significant change in mean FEV1 demonstrates the drug's ability to quickly reduce bronchoconstriction in asthma patients. The improvements in FEV1 and favorable cardiac safety findings also suggest that MN-221 could be broadly useful in management of asthma and other obstructive lung diseases such as chronic obstructive pulmonary disease. We look forward to further progressing MN-221 through clinical development."
The randomized, double-blind, placebo controlled, dose-escalation Phase IIa study included 23 mild-to-moderate asthmatics at four clinical centers in the United States. At each dose level in the escalation, patients were randomized to receive either a 15-minute intravenous infusion of MN-221 or placebo. MN-221 produced a significant linear, dose-related increase in mean change in post-infusion FEV1 from baseline (p less than or equal to 0.0001) following a 15-minute intravenous infusion of MN-221. Significant improvements in mean change in post-infusion (15 minute) FEV1 from baseline were observed at doses of 10, 16, 30 and 60 micrograms/min (p less than or equal to 0.0006) and at the dose of 3.5 micrograms/min (p=0.0106), compared to placebo. In the protocol correct population, the dose-related increases in FEV1 were maintained for four hours (p=0.0393) and at eight hours (p=0.0424) following the 15-minute infusion of MN-221. MN-221 was well tolerated in this trial, with only the expected beta2-adrenergic receptor pharmacology (e.g., fall in serum potassium, elevation in plasma glucose, mild headache, mild tremors) noted in some patients. There were no clinically significant cardiovascular, ECG, or vital sign changes, nor were there any other safety concerns observed at any dose tested. No serious adverse effects were observed in this trial.
Dr. Iwaki continued, "MN-221 could potentially represent the first product in our pipeline to reach commercialization. Based on the results of this study, we expect to evaluate the effects of longer infusions in a second Phase IIa study in stable asthmatic patients and to advance MN-221 into a Phase IIb clinical trial in patients with status asthmaticus in an emergency department setting in early 2008."
MN-221 is highly-selective beta2-adrenergic receptor agonist. 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 currently used to treat status asthmaticus. Moreover, in vitro studies also suggest that MN-221 may act as only a partial beta1-adrenergic receptor agonist in cardiac tissue, while acting as a full beta2-adrenergic receptor in the lung. This improved receptor binding and functional selectivity may result in fewer cardiovascular side effects than are commonly observed with other beta2-adrenergic receptor agonists used to treat this condition. 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.
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.
Conference Call/Webcast Information
MediciNova will host a conference call and audio webcast to discuss the Phase IIa results. The call is scheduled for today, October 9th, at 10:00 A.M. Eastern time. To participate in this call, dial 800-591-6923 (domestic), 617-614-4907 (international), passcode: 97452425, shortly before 10:00 A.M., Eastern time. For a limited period following the call, a replay of the call will be available, beginning at 12:00 P.M. Eastern time; the replay can be accessed by calling 888-286-8010 (domestic), 617-801-6888 (international), passcode: 75196041. The audio webcast will be available on MediciNova's website (www.medicinova.com) for approximately 60 days following the call.
MediciNova, Inc. is a publicly-traded biopharmaceutical company that acquires well characterized small-molecule drugs through strategic alliances with Japanese and other international pharmaceutical companies and accelerates their development in a diversified portfolio of therapeutic product candidates targeting significant disease markets. 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. MediciNova's strategy is to commercialize selected product candidates in the United States and to monetize other programs at key value inflection points. 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 MediciNova's clinical trials supporting efficacy of product candidates and the potential novelty of such product candidates as treatments for disease, plans and objectives for present and future clinical trials and product development and commercialization, strategies and future performance. These forward-looking statements may be preceded by, followed by or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "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 and 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, MediciNova's reliance on third parties and the timing, cost and design of future clinical trials and research activities, the timing of expected filings with the FDA, the failure to execute strategic plans or strategies successfully, MediciNova's collaborations with third parties, intellectual property or contract rights, 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, 2006 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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Posted: October 2007