Patent for 20 year old Ibudilast for the treatment of Primary Progressive form of multiple sclerosis
SAN DIEGO, Calif., Feb. 1, 2012 (GLOBE NEWSWIRE) --MediciNova Inc, a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV - News) and the Jasdaq Market of the Osaka Securities Exchange (4875), today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application, which covers the use of ibudilast for the treatment of progressive forms of multiple sclerosis. Ibudilast (MN-166), is the company's lead drug development candidate for certain neurological conditions, including progressive multiple sclerosis, neuropathic pain, and drug addiction.
A patent maturing from this allowed patent application is expected to expire no earlier than early 2029 and covers a method of treating primary progressive multiple sclerosis (PPMS) or secondary progressive MS (SPMS) by administering ibudilast either alone or in combination with other drugs. The patent application is based upon clinical investigations conducted by MediciNova researchers which showed an apparent disease-modifying benefit in which brain volume loss, or brain atrophy, commonly associated with disease progression, was reduced by oral administration of ibudilast to a group of multiple sclerosis patients including some subjects with progressive multiple sclerosis, in a dose-related fashion over at least a 10-month treatment period.
Multiple sclerosis (MS) is recognized as a chronic disease in which disability progresses over time. Patients suffering from progressive forms of MS tend to have a poor prognosis and have greater levels of disability. Robert J. Fox, M.D., M.S., FAAN, Medical Director of Mellen Center for MS, Cleveland Clinic, noted that, "Despite recent improvements in pharmacotherapy for relapsing remitting multiple sclerosis, treatment options in progressive multiple sclerosis are extremely limited in the absence of relapses. There is great need for safe, effective, and conveniently-administered therapies for progressive MS."
Obtaining long-term protection of market exclusivity for the use of ibudilast in certain neurological conditions has been a key component of MediciNova's development strategy for the MN-166 program. Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, noted that, "We are very pleased to receive notice of this patent allowance for ibudilast in progressive MS. Moreover, we anticipate that this allowance will facilitate further development and business options around this program."
Ibudilast has been used in asthma and post-stroke disorders in Japan for around 20 years. MediciNova has demonstrated the potential utility of ibudilast in the treatment of neurological disorders at higher doses with encouraging outcomes in company-sponsored clinical trials in multiple sclerosis (MS) and neuropathic pain. MediciNova's collaborative trial planning with drug addiction investigators at organizations like Columbia/NYSPI and UCLA has led to National Institute on Drug Abuse (NIDA)-to support clinical investigations of the use of ibudilast to treat both opioid and methamphetamine addiction. A Phase 2 investigator-sponsored trial of ibudilast in the treatment of chronic medication overuse headache (MOH) pain is also ongoing in Australia. MediciNova's priorities include pursuing Phase 2 proof-of-concept trials of ibudilast for the treatment of progressive MS and/or neuropathic pain through non-dilutive funding.