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Posted: Mon Feb 06, 2006 10:47 am Post subject: Enrollment for Phase II trial of MN-166 complete
Progress...
MediciNova Announces Completion of Enrollment in a Phase II Multiple Sclerosis Trial With MN-166
Feb. 6 /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.
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