This Is MS - MN-166 Enters Phase II trials in US | Unbiased Multiple Sclerosis Research, News, and Support Community

MediciNova announced today the completion of enrollment in a sizable (297 patients) Phase II clinical trial of a drug they call MN-166. There are a few interesting things about MN-166 that make it particularly noteworthy (of course, we find all potential new treatments inherently noteworthy!), including the following:

It is an orally delivered drug (!)

It has already been used in Asia for 16 years (!) to treat asthma and other cerebrovascular disorders, and the company indicates that post-marketing data for the 15,000 patients that have taken it for those indications demonstrates it to be safe and effective

Though Phase II is a two-year trial, partial efficacy data will be released next year at this time

There is a concurrent Phase II trial in Eastern Europe that has a 6 month head start on the US version.

MN-166 is said to inhibit leukotriene activity, phosphodiesterases and nitric oxide synthase, which are generally accepted as inflammatory mechanisms involved (somehow) with MS.

In other words, this is a promising treatment with a needle-free delivery mechanism and long history of product safety. Of course, the FDA trial process is quite lengthy and given the current stage (early Phase II), the drug would be unavailable for general use by MS'ers for at least 4 more years. The best takeaway at this point is that the days of injectable MS drugs being the *only* effective option are seriously numbered, and becoming increasingly so by the day.

Please click "read more" for more details.

Official Press Relase

MediciNova Announces Completion of Enrollment in a Phase II Multiple Sclerosis Trial With MN-166

SAN DIEGO, Feb. 6, 2006 /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 of 297 patients with relapsing multiple sclerosis (MS) in its Phase II clinical trial of MN-166.

MN-166 is a novel, orally administered compound being evaluated for the treatment of MS. In July 2005, MediciNova initiated a randomized, double-blind, placebo-controlled multi-center Phase II clinical trial of MN-166 in MS patients in Eastern Europe. Two hundred and ninety-seven (297) patients have been randomized to receive placebo or one of two doses of MN-166 in this trial. Efficacy data is expected after one year of treatment (in this two year trial) in 1Q07.

MN-166 inhibits leukotriene activity, phosphodiesterases and nitric oxide synthase, all inflammatory mechanisms known to be involved in MS. Recently, MN-166 was found to have beneficial effects in several pilot clinical trials conducted in MS patients in Japan. These findings led to the issuance of a new U.S. method of use patent for MN-166 in 2002.

"MN-166 may be an effective new approach to treating MS with the added advantage of oral dosing. Rapid completion of enrollment in this relatively large trial demonstrates our commitment to advancing our clinical programs efficiently though the Phase II proof-of-concept stage and beyond," said Yuichi Iwaki, M.D., Ph.D., Executive Chairman and Acting CEO of MediciNova, Inc.

MediciNova acquired the rights to MN-166 from Kyorin Pharmaceutical Co. Ltd. for global markets excluding Japan, China, Taiwan and South Korea. For the past 16 years, MN-166 has been marketed in Japan and South Korea as Ketas(R) for the treatment of asthma and cerebrovascular disorders. Data from the existing clinical trial and post-marketing surveillance databases, which includes treatment of an estimated 3.2 million patients with these disorders, indicate that Ketas(R) is well tolerated.

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.

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/