SAN DIEGO, Oct. 18, 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 results from a Phase IIa clinical study of MN-305, its product candidate for the treatment of insomnia. The clinical study failed to achieve statistical significance in its primary endpoint of reducing Wake (time) After Sleep Onset (WASO). MN-305 was well tolerated in this study with no clinically significant adverse events observed at any dose tested. There was no evidence of any decrements in psychomotor performance, as assessed in Digit Symbol Substitution and Symbol Copying tests, in patients treated with MN-305.
"While we are disappointed by the results of this pilot study, they will not significantly impact the future or direction of the company. We will terminate the evaluation of MN-305 in insomnia and will focus on out-licensing this product candidate for psychiatric disorders," said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc. "As announced in June, we remain focused on advancing two core assets, MN-221 for the treatment of status asthmaticus, for which we recently announced positive Phase IIa data, and MN-166 for the treatment of multiple sclerosis, which also demonstrated positive clinical benefits in the first year analysis of a two-year Phase II clinical trial. We will continue to move these two product candidates forward in clinical development while pursuing a range of business development opportunities for the other product candidates in our pipeline."
The randomized, double-blind, placebo-controlled, four-period crossover dose-response Phase IIa study included 90 patients with primary insomnia characterized by sleep maintenance difficulties at ten clinical centers in the United States. Each patient received three dosages of MN-305 (1 mg, 3 mg and 6 mg) and placebo, administered orally approximately 60 minutes before bedtime for seven consecutive nights (Nights 1 to 7). On Nights 1 to 5, the patients were dosed at home as outpatients. On Nights 6 and 7, patients returned to the study center and underwent eight hours (960 epochs) of PSG recording each evening.
About MN-305
MN-305 is a potent and highly-selective full agonist at the serotonin 5-HT1A receptor under development by MediciNova both for the treatment of insomnia, as well as for anxiety disorders such as Generalized Anxiety Disorder (GAD). MN-305 has been evaluated in an extensive preclinical toxicology program which showed no evidence of inducing genetic mutations, immune response or cancer. MN-305 has also proved to be consistently well-tolerated in clinical safety, efficacy and pharmacokinetic studies in over 1,200 subjects.
MediciNova acquired a license to MN-305 from Mitsubishi Tanabe Pharma Corporation for global markets, with the exception of Japan and other selected Asian countries. The data acquired from Mitsubishi Tanabe Pharma Corporation includes extensive preclinical and clinical safety results, including that from full carcinogenicity testing in rodents.
About MediciNova
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, 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.