On October 4, 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 U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to MN-166 (ibudilast) as adjunctive therapy to temozolomide for the treatment of glioblastoma (GBM) (Press release, MediciNova, OCT 4, 2018, View Source;p=irol-newsArticle&ID=2370393 [SID1234529793]).
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Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are very pleased that the FDA has granted orphan-drug designation for MN-166 as adjunctive therapy to temozolomide for the treatment of GBM, a rare cancer with a high recurrence rate and poor prognosis."
About Glioblastoma
According to the American Association of Neurological Surgeons, glioblastoma (GBM) is a devastating brain cancer that typically results in death in the first 15 months after diagnosis. An aggressive, extremely lethal form of brain malignancy, GBM 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. GBM has an incidence of 2-3 per 100,000 adults per year. 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 Orphan Drug Designation
Drugs that receive orphan-drug designation from FDA are entitled to seven years of marketing exclusivity if they are approved by the FDA for the same rare disease. The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.
About MN-166 (ibudilast)
MN-166 (ibudilast) has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MediciNova is developing MN-166 for progressive multiple sclerosis (MS) and other neurological conditions such as ALS and substance abuse/addiction. MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule phosphodiesterase (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 neurodegenerative diseases (e.g., progressive MS and ALS), substance abuse/addiction and chronic neuropathic pain. MediciNova has a portfolio of patents which cover the use of MN-166 (ibudilast) to treat various diseases including progressive MS, ALS, and drug addiction.