SAN DIEGO, March 21, 2012 (GLOBE NEWSWIRE) -- MediciNova, Inc. a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the Jasdaq Market of the Osaka Securities Exchange (4875), today announced it has completed enrollment in its Phase 2 clinical trial (MN-221-CL-007) evaluating the safety and efficacy of MN-221 for treatment of acute exacerbations of asthma. Patients suffering from acute exacerbations of asthma in the emergency room who were not promptly responding to standard pharmacotherapy were enrolled in the study. MediciNova is currently in the process of auditing and organizing the data and preparing to lock the database for a complete analysis. MediciNova anticipates releasing preliminary results in the second quarter of 2012.
MN-221-CL-007 is a randomized, double-blind, placebo-controlled Phase 2 clinical trial. The trial enrolled a total of 176 patients and was conducted at ~20 sites in the United States. Once a patient received the initial standardized care treatment regimen (consistent with the National Asthma Education and Prevention Program (NAEPP) and the Global Initiative for Asthma (GINA) guidelines), the patient was assessed for response to that treatment. If the patient's forced expiratory volume in one second (FEV1) was less than or equal to 50 percent of predicted FEV1 and the patient met all other study entry criteria, the patient was randomized to receive either MN-221 or placebo, while continuing to receive standardized care as needed. The primary efficacy endpoint is improvement in FEV1. A number of secondary endpoints including reduction in hospital admissions and various clinical significances will be examined.
"We are pleased to have completed patient enrollment and will announce results after we've completed a comprehensive review of the data," said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc. "This keeps us on track for planning the further development of MN-221 in the treatment of acute asthma exacerbations."
About MN-221
MN-221 is a novel, highly selective beta(2)-adrenergic receptor agonist in development for the treatment of acute exacerbations of asthma and COPD. An exacerbation is defined as an acute, long-lasting and severe asthma/COPD episode that is not responsive to the standard bronchodilator or corticosteroid therapy. Patients with an asthma/COPD exacerbation typically go to the emergency room (ER) for treatment. If treatment in the ER is not successful, the patient may be admitted to the hospital.
Current inhaled beta-agonist treatments for asthma and COPD exacerbations are limited by bronchoconstriction or insufficient airflow due to inflammation and airway constriction, reducing the amount of inhaled drug that can get into the lungs. In addition, the amount of inhaled treatments a patient can tolerate is limited due to the potential for cardiovascular side effects (increased heart rate).
MN-221 is designed to treat acute exacerbations via intravenous infusion, bypassing constricted airways to deliver the drug directly to the lungs. Preclinical studies showed MN-221 to have a high affinity for the beta(2)-adrenergic receptor, found primarily in the lungs, and a much lower affinity for the beta(1)-adrenergic receptor found primarily in cardiac tissue. These studies showed no worrisome increase in heart rate when MN-221 was administered.
MN-221's improved delivery to the lungs and its cardiac safety profile may help fill an unmet need for patients with asthma or COPD exacerbations, helping them to breathe easier and avoid a costly hospital stay.
MediciNova acquired an exclusive, worldwide (excluding Japan), sublicensable license to MN-221 from Kissei Pharmaceutical Co., Ltd.
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 the timing of our release of preliminary clinical trial results, the potential utility of ibudilast in the treatment of progressive MS and other neurological disorders and the proposed proof of concept trial of ibudilast, including any implication that the company will have the ability to execute on its priorities. 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 risk and certainties of raising additional capital to fund clinical development of ibudilast, 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.