This randomized, open-label, placebo-controlled Phase II clinical trial involved 17 patients in two dose cohorts at four clinical sites in the United States. In one dosing cohort, each patient received MN-221 at a dose of 1,125 micrograms or placebo over one hour by a continuous intravenous infusion. In the other dosing cohort, each patient received MN-221 at a dose of 1,080 micrograms or placebo over two hours by a continuous intravenous infusion. Based on preliminary findings, both infusion rates of MN-221 produced a marked and clinically significant improvement in FEV1. FEV1 results were expressed as ``percent predicted'' based on standard reference equations accounting for an individual's race, gender, age and height. At the end of the one-hour infusion, FEV1 increased by 17.5 percent predicted for MN-221 compared to an increase of 3 percent predicted for placebo. At the end of the two-hour infusion, FEV1 increased by an average of 12.1 percent predicted for MN-221 compared to an increase of 1.4 percent predicted for placebo. Per the study protocol, no inferential statistical testing was performed. MN-221 was well tolerated by the patients who received either infusion rate of MN-221. There were no clinically significant safety concerns noted among adverse events, electrocardiogram (ECG) data, vital sign data or laboratory assessments collected throughout the study.
``We continue to be very encouraged by the data derived from the various clinical trials evaluating MN-221 completed to date,'' said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc. ``This clinical trial, in particular, provided us with meaningful insight into the potential safety and efficacy of MN-221 with more prolonged infusions and with different infusion rates in patients with moderate to severe, but stable, asthma. This clinical trial for MN-221, in parallel with our other Phase II clinical trial currently underway in patients with severe, acute exacerbations of asthma treated in the Emergency Department (ED), will assist us in designing a larger Phase IIb clinical trial, which we hope to initiate during peak asthma attack season this winter.''
About MN-221
MN-221 is highly-selective Beta2-adrenergic receptor agonist. Preclinical testing in vitro and in vivo showed MN-221 to be more selective for the Beta2-adrenergic receptor than other Beta2-adrenergic receptor agonists commonly used in treating asthma attacks. This improved selectivity, coupled with its partial agonist activity at Beta1-adrenergic receptors, 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 to deliver effective concentrations of the drug to the lungs. MN-221 has been shown recently to produce significant improvements in mean change in post-infusion (15 minute) FEV1 from baseline (objective measure of lung function) at doses of 3.5 micrograms/min (p=0.011), and at 10, 16, 30 and 60 micrograms/min (p less than or equal to 0.0001), compared to placebo in stable mild-to-moderate asthma patients.
MediciNova acquired an exclusive, worldwide (excluding Japan), sublicensable license to MN-221 from Kissei Pharmaceutical Co., Ltd. The intellectual property acquired from Kissei included extensive preclinical and clinical safety data.
About MediciNova
MediciNova, Inc. is a publicly-traded biopharmaceutical company focused on acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet need with a specific 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 assets having claims of commercially adequate scope. MediciNova's pipeline includes six clinical-stage compounds for the treatment of acute exacerbations of asthma, multiple sclerosis, 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 its resources on the development and commercialization of two prioritized assets in its development pipeline: MN-221 for the treatment of acute exacerbations of asthma and MN-166 for the treatment of multiple sclerosis. MediciNova will seek to monetize its other product candidates at key value inflection points. For more information on MediciNova, Inc., please visit http://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 safety and 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, strategies, future performance, expectations, assumptions, financial condition, liquidity and capital resources. 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, 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 FDA, MediciNova's failure to execute strategic plans or strategies successfully, 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, 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, 2007 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.
Contact:
MediciNova, Inc. Shintaro Asako, Chief Financial Officer 858-373-1500 info@medicinova.com
Rx Communications, LLC Rhonda Chiger (917) 322-2569 rchiger@rxir.com
Source: MediciNova, Inc.
