On May 9, 2018 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), reported that the Investigational New Drug Application (IND) for MN-166 (ibudilast) for treatment of glioblastoma (GBM) has been accepted and is now open with the U.S. Food and Drug Administration (FDA) (Press release, MediciNova, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2348327 [SID1234526377]). MediciNova was informed by the FDA that the proposed clinical investigation of MN-166 (ibudilast) in combination with temozolomide (TMZ) for treatment of GBM may proceed.
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"We are very pleased that this important regulatory step is now completed, as we can now pursue clinical development of MN-166 in GBM, a devastating type of cancer with a high recurrence rate and very poor prognosis. As we previously reported, combination treatment of MN-166 (ibudilast) and TMZ improved survival compared to TMZ-only treatment in a GBM animal model study," commented Yuichi Iwaki, MD, PhD, President and CEO of MediciNova, Inc.
About GBM (glioblastoma)
According to the American Association of Neurological Surgeons, glioblastoma (GBM) is an aggressive, extremely lethal form of brain malignancy that develops from glial cells (astrocytes and oligodendrocytes) and rapidly grows and commonly spreads into nearby brain tissue. GBM is classified as Grade IV, the highest grade, in the World Health Organization (WHO) brain tumor grading system. The American Brain Tumor Association reports that GBM represents 15% of all brain tumors and 56% of all gliomas and has the highest number of cases of all malignant tumors, with an estimated 12,760 new cases predicted for 2018. Despite decades of advancements in neuroimaging, neurosurgery, chemotherapy, and radiation therapy, only modest improvements have been achieved and the prognosis has not improved for individuals diagnosed with GBM. Median survival is 14.6 months and two-year survival is 30%. Only approximately 5% of GBM patients survive longer than 36 months.
About MN-166
MN-166 (ibudilast) has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule phosphodiesterases (PDE) 4 and 10 inhibitor and a macrophage migration inhibitory factor (MIF) inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. It attenuates activated glia cells, which play a major role in certain neurological conditions. Ibudilast’s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical study results and provide the rationale for its therapeutic utility in substance use disorders, neurodegenerative diseases (e.g., ALS and progressive MS), and chronic neuropathic pain. MediciNova is developing MN-166 for various neurological conditions such as progressive MS, ALS and substance abuse/addiction.