MediciNova completes enrollment in a phase 2/ 3 anxiety disorder trial with MN-305

By E. Janene Geiss

Philadelphia, Feb. 27 - MediciNova, Inc. announced Monday the completion of enrollment in its phase 2/ 3 clinical trial of MN-305 in 416 patients with generalized anxiety disorder.

"MN-305 may offer effective treatment of generalized anxiety disorder without the side effects ... associated with antidepressants currently used to treat anxiety disorders," Yuichi Iwaki, executive chairman and acting chief executive officer, said in a company news release.

"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 3 clinical testing," Iwaki added.

In December 2004, MediciNova said it began a randomized, double-blind, placebo-controlled, multi-center phase 2/ 3 clinical trial of MN-305 in generalized anxiety disorder patients.

To date, 416 patients have been randomized to receive a placebo or one of two flexible dose regimens of MN-305 at 25 clinical sites in the United States.

The results from this trial are expected by the end of the second quarter, officials said.

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 generalized anxiety disorder.

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 Corp. in a group of patients with a variety of anxiety disorders, officials said.

MN-305 was well-tolerated in previous clinical studies involving more than 800 volunteers and patients with either anxiety or mood disorders, officials said.

Generalized anxiety disorder 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. Generalized anxiety disorder affects about 4 million people.

MediciNova said it acquired a license to MN-305 from Mitsubishi Pharma Corp. 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.

MediciNova is a San Diego specialty pharmaceutical company focused on accelerating development and commercialization of innovative pharmaceutical products. The company's pipeline, which includes several compounds in clinical testing, targets prevalent medical conditions, including cancer, asthma, generalized anxiety disorder, multiple sclerosis, interstitial cystitis, preterm labor and urinary incontinence.

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