SAN DIEGO, Aug. 17, 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 its Phase Ib clinical trial of MN-221 for the treatment of preterm labor. Target plasma concentrations were achieved with an intravenous priming followed by maintenance infusion dosing paradigm. No significant safety concerns with MN-221 were identified in this clinical trial.
The Phase Ib clinical trial enrolled 10 healthy, pregnant volunteers who were not in labor. The volunteers received a single-dose intravenous infusion regimen of MN-221, consisting of two consecutive rounds of a 15-minute priming and a 105-minute maintenance infusion to deliver 294 micrograms of MN-221 over four hours. The primary objectives of this clinical trial were to determine the pharmacokinetics, safety and tolerability of this infusion regimen of MN-221 in pregnant women.
"Preterm labor is another potential indication for MN-221, which is also currently in a Phase IIa clinical trial for status asthmaticus," said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova. "Our near term focus for MN-221 is in progressing the compound in the treatment of status asthmaticus. However, the additional safety and pharmacokinetic information resulting from this Phase Ib clinical trial is extremely valuable as we compile regulatory dossiers. We look forward to reporting on the results of the Phase IIa clinical trial for status asthmaticus in the fourth quarter of this year."
MN-221 is a highly-selective beta2-adrenergic receptor agonist under development by MediciNova for the treatment of status asthmaticus and preterm labor. Preclinical testing in vitro and in vivo shows MN-221 to be more selective for the beta2-adrenergic receptor than other beta2-adrenergic receptor agonists used to treat these conditions. This improved selectivity 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 is appropriate for use in emergency facilities.
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, insomnia, 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, 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, MediciNova's reliance on third parties and the timing, cost and design of future clinical trials and research activities, the failure to execute strategic plans or strategies successfully, MediciNova's collaborations with third parties, failure to obtain or maintain FDA approval, 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.