SAN DIEGO, Feb. 27 /PRNewswire/ -- MediciNova, Inc., a specialty pharmaceutical company that is publicly traded on the Hercules Market of the Osaka Securities Exchange (Code Number: 4875), today announced completion of enrollment in its Phase II/III clinical trial of MN-305 in 416 patients with Generalized Anxiety Disorder (GAD).
“MN-305 may offer effective treatment of GAD without the side effects (e.g., increased risk of suicide, sexual dysfunction, agitation) associated with antidepressants currently used to treat anxiety disorders such as GAD,” said Yuichi Iwaki, M.D., Ph.D., Executive Chairman and Acting CEO of MediciNova, Inc. “Completion of enrollment in a large, pivotal-design trial demonstrates MediciNova’s commitment to advancing our clinical programs through at least the proof-of-concept stage and into Phase III clinical testing.”
In December 2004, MediciNova initiated a randomized, double-blind, placebo-controlled multi-center Phase II/III clinical trial of MN-305 in GAD patients. Four hundred and sixteen (416) patients have been randomized to receive placebo or one of two flexible dose regimens of MN-305 at 25 clinical sites in the U.S. The results from this trial are expected by the end of 2Q 2006.
MN-305 is a novel, potent and highly selective serotonin 5-HT(1A) receptor agonist under development by MediciNova for the treatment of anxiety disorders beginning with GAD. This orally bioavailable compound has shown preliminary evidence of efficacy in animal models of anxiety and in an open-label study conducted in Japan by Mitsubishi Pharma Corporation in a group of patients with a variety of anxiety disorders. MN-305 was well tolerated in previous clinical studies involving over 800 volunteers and patients with either anxiety or mood disorders.
GAD is a mental disorder consisting of chronic, excessive worry and fear that seems to have no real cause. This anxiety disorder is characterized by the presence of excessive, uncontrollable anxiety and worry about two or more life circumstances for six months or longer, accompanied by some combination of restlessness, fatigue, muscle tension, irritability, disturbed concentration or sleep, and somatic symptoms. More than 19 million Americans suffer from anxiety disorders: GAD affects about 4 million people, panic disorder about 2.8 million, phobias roughly 3.5 million, obsessive-compulsive disorder 4.2 million and post-traumatic stress disorder about 3.2 million.
MediciNova acquired a license to MN-305 from Mitsubishi Pharma Corporation for global markets, with the exception of Japan and other selected Asian countries. The data acquired from Mitsubishi includes extensive preclinical and clinical safety data, including that from full carcinogenicity testing in rodents.
About MediciNova
MediciNova, Inc. is a publicly traded specialty pharmaceutical company focused on accelerating the global development and commercialization of innovative pharmaceutical products. MediciNova’s pipeline, which includes several compounds in clinical testing, targets a variety of prevalent medical conditions, including cancer, asthma, Generalized Anxiety Disorder, multiple sclerosis, interstitial cystitis, preterm labor and urinary incontinence. 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/
