SAN DIEGO, Nov. 16 /PRNewswire/ -- MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Hercules Market of the Osaka Securities Exchange (Code Number: 4875), today announced the initiation of its Phase III clinical program to determine the safety and efficacy of its novel oral treatment for bronchial asthma (MN-001) in asthma patients.
The first Phase III trial in this program will involve approximately 705 asthma patients enrolled at 75 - 90 clinical sites in the U.S. Mild-to-moderate asthma patients will receive placebo or MN-001 (750 mg BID, 500 mg TID) for 12 weeks in this randomized, placebo-controlled, double-blind study. The primary endpoint of the trial will be the change from baseline in mean FEV1 (forced expiratory volume in 1 second) after 12 weeks of treatment. Secondary outcome measures will include a self-administered Asthma Quality of Life Questionnaire, the change from baseline in morning and evening peak flow rates, rescue beta-agonist use, serial spirometry parameters including assessment of acute effects following first dose on Day 1, daytime asthma symptom scores, nighttime awakenings from asthma, physician’s global assessment, number of asthma exacerbations, discontinuations due to asthma, Clinical Global Impression evaluations and change in urinary LTE4 levels. Additional Phase III trials are planned. Development of a continuous release formulation of MN-001 will parallel the initial Phase III trials.
MN-001 is a novel, orally bioavailable compound that has been shown to block a number of the inflammatory mechanisms activated by mast cell degranulation (e.g., leukotriene receptor antagonism and inhibition of phosphodiesterases III and IV, 5-lipoxygenase, phospholipase C and thromboxane A2) that are important in the pathogenesis of inflammatory disorders including asthma. Positive results from a randomized, double-blind, placebo-controlled multi-center Phase II clinical trial in patients with mild-to-moderate asthma were announced in December 2005. In this study, one hundred and forty-seven (147) patients were randomly assigned to receive placebo or MN-001 tablets in one of three oral dosing regimens (500 mg TID, 750 mg BID, 750 mg QD) for 4 weeks. The primary endpoint of the trial was achieved with a statistically significant improvement in mean FEV1 after four weeks of treatment with 500 mg MN-001 TID compared to placebo (p<0.021; intent-to-treat, observed cases). A similar trend was observed for the 750 mg BID dose (p<0.058). Positive trends in secondary outcome measures were also observed in the 500 mg TID treatment group, including serial spirometry, morning and evening peak flow rates and PC20 values in a methacholine challenge test (common measures of respiratory function). MN-001 was well tolerated in this trial with 89% of patients completing four weeks of treatment. There was no apparent difference between placebo and any of the active treatment groups in adverse events leading to discontinuation or in adverse events attributable to treatment. No serious adverse events were reported in this trial.
MN-001 is also under development by MediciNova for the treatment of interstitial cystitis. MN-001 is currently being evaluated in a pivotal-design Phase II/III clinical trial in 305 patients with moderate-to-severe interstitial cystitis at 39 clinical sites in the U.S. MediciNova anticipates having results from this trial by the beginning of 2007.
MediciNova acquired a license to MN-001 from Kyorin Pharmaceutical Co. Ltd. for global markets excluding Japan, China, Taiwan and South Korea. The intellectual property acquired from Kyorin included extensive preclinical and clinical safety data.
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, preterm labor, urinary incontinence and thrombotic disorders. For more information on MediciNova, Inc., please visit www.medicinova.com.
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.
MediciNova, Inc.
CONTACT: Kenneth W. Locke, Ph.D., Chief Business Officer of MediciNova,Inc., +1-858-373-1200, locke@medicinova.com
Web site: http://www.medicinova.com/
