Healthcare Industry News: Kissei Pharmaceutical
News Release - April 22, 2009
MediciNova Reports Final Data from Phase II MN-221 Emergency Department Clinical Trial (MN-221-CL-006); Hospitalization Rates Decrease 45 Percent With MN-221 Plus Standardized Care in Asthma Patients
MediciNova's Phase II Placebo-controlled Clinical Trial (MN-221-CL-007) Evaluating MN-221 in Patients with Severe, Acute Exacerbations of Asthma is Actively Enrolling PatientsSAN DIEGO, April 22, 2009 -- (Healthcare Sales & Marketing Network) -- MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market (NasdaqGM:MNOV ) and the Hercules Market of the Osaka Securities Exchange (Code Number: 4875), today announced final results from its Phase II clinical trial (MN-221-CL-006) evaluating MN-221 at planned escalating doses of 240 to 1,080 micrograms in patients with severe, acute exacerbations of asthma treated in Emergency Departments. The study included 29 (13 treated with standard care only and 16 treated with MN-221 plus standard care) patients with severe, acute exacerbations of asthma. All patients received standardized care consisting of inhaled albuterol, ipratropium and oral steroid treatment. No safety concerns with adding MN-221 to standardized care were identified following review of electrocardiogram (ECG), laboratory and Adverse Experience data. The hospitalization rate among patients treated with standardized care only was 46 percent (six of 13), which was the anticipated rate, compared to a hospitalization rate of 25 percent (four of 16) among patients receiving MN-221 plus standardized care. This represents a 45 percent reduction in hospitalization rate among patients treated with MN-221. All hospitalizations were due to asthma exacerbations which were judged to be unrelated to study medication and therefore do not raise safety concerns for adding MN-221 to standardized care. As specified in the protocol for this clinical trial, no inferential statistics (i.e., p-values) were calculated for this study. Improvement in forced expiratory volume in 1 second (FEV(1)) values generally appeared to be greater for patients receiving MN-221 in addition to standardized treatment.
``These clinical results are consistent with the interim data reported from this study in January and demonstrate the potentially beneficial effect of MN-221 in the treatment of severe, acute exacerbations of asthma,'' said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc. ``The benign safety profile of MN-221 and the 45 percent reduction in hospitalization rate observed are encouraging.''
MediciNova also announced that its MN-221-CL-007 study, a randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the safety and efficacy of MN-221 in patients with severe, acute exacerbations of asthma, has begun enrolling patients in the United States. The majority of investigators who participated in the MN-221-CL-006 study have rolled over to the MN-221-CL-007 study.
MediciNova expects to enroll approximately 200 patients at approximately 35 Emergency Department clinical sites, including the clinical sites rolled over from the MN-221-CL-006 study, in North America, Australia and New Zealand. The MN-221-CL-007 study is designed to compare standardized care to standardized care plus MN-221 at a dose of 1.2 mg administered over one hour. Once a patient has received the initial standardized care treatment regimen (consistent with the National Asthma Education and Prevention Program and the Global Initiative for Asthma (GINA) guidelines), the patient will be assessed for response to that treatment. If the patient's FEV(1) is less than or equal to 50 percent of predicted and the patient meets all other study entry criteria, the patient will be randomized to receive either MN-221 or placebo. Patients enrolled in the study will continue to receive standardized care as needed while receiving an intravenous infusion of MN-221 or placebo. The primary efficacy endpoint will be improvement in FEV(1). Enrollment of study participants began in April 2009 in the North American clinical sites and is anticipated to begin by June 2009 in the Australia and New Zealand clinical sites. Enrollment is expected to be complete within nine to 12 months.
Dr. Iwaki continued, ``We look forward to building upon the encouraging data currently available for MN-221 by evaluating the compound in this planned larger, placebo-controlled clinical trial, which will work toward advancing our objective of developing MN-221 for treatment of severe acute exacerbations of asthma in our market territory.''
About MN-221
MN-221 is highly-selective beta(2)-adrenergic receptor agonist. Preclinical testing in vitro and in vivo shows MN-221 to be more selective for the beta(2)-adrenergic receptor than other beta(2)-adrenergic receptor agonists commonly used for these asthma attacks. This improved selectivity, coupled with its partial agonist activity at beta(1)-adrenergic receptors, may result in fewer cardiovascular side effects than are commonly observed with these other agents. MediciNova has developed an intravenous formulation of MN-221 that bypasses the constricted airways to deliver the drug to the lungs. In addition to the data described above, MN-221 has been shown to produce significant improvements in mean change in post-infusion (15 minute) FEV(1) 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 (MN-221-CL-004). Administration of MN-221 at a dose of approximately 1.1 mg over intervals of 1 or 2 hours also produced marked improvement in FEV(1) in patients with moderate-to-severe stable asthma (MN-221-CL-005). In addition, administration of 1.1 mg of MN-221 over 1 hour produced the greatest FEV(1) improvement of the regimens tested in these two studies. A recently completed drug interaction study in dogs found that adding MN-221 by intravenous administration in combination with inhaled albuterol does not add to the heart rate increase associated with inhaled albuterol alone.
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 its two prioritized product candidates, MN-221 for the treatment of acute exacerbations of asthma and MN-166 for the treatment of multiple sclerosis, and either pursue development independently, in the case of MN-221, or establish a strategic collaboration to support further development, in the case of MN-166. 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.
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, 2008. 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.
Source: MediciNova
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