On June 5, 2017 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 Associate Professor Kerrie McDonald, Head of the Cure Brain Cancer Foundation Biomarkers and Translational Research Group at the Lowy Cancer Research Centre, University of New South Wales, today presented positive results from an animal model study that examined the potential clinical efficacy of MN-166 (ibudilast) for the treatment of glioblastoma at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 5th , 2017 in Chicago, Illinois (Press release, MediciNova, JUN 5, 2017, View Source [SID1234519412]). Schedule your 30 min Free 1stOncology Demo! Major highlights of the presentation titled "Treating glioblastoma with a cytokine inhibitor, ibudilast in combination with temozolomide extends survival in a patient derived xenograft model," are summarized as follows:
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Tumor samples from glioblastoma (GBM) patients, divided into two groups according to overall survival (i.e., "poor survivors" were defined by survival of less than 12 months and "good survivors" were defined by survival of more than 12 months) were examined for protein overexpression.
Proteomics analysis in frozen GBM tissues identified Macrophage Migration Inhibitory Factor (MIF) overexpression in the cells from "poor survivors;"
Among 168 GBM patient-derived tumor tissue samples, MIF and its receptor CD-74 were significantly over-expressed in 57% of patients and were found to be associated with poor survival.
A mouse model of GBM was developed by using patient-derived GBM cells and treated with temozolomide (TMZ) (10mg/kg) alone and combination with ibudilast (5mg/kg or 20mg/kg). Findings from this mouse model included the following:
Median survival for the group that received TMZ treatment-only increased by 5 days (105.5 days p=0.054) compared to the control group;
Median survival for the group that received combination treatment of ibudilast (5mg/kg or 20mg/kg) with TMZ increased by 13.5 days and 11 days, respectively (114 days and 111.5 days, respectively, (p=0.005)), compared to the control group.
Median survival for the control group (i.e., no treatment) was 100.5 days.
Significant synergism between ibudilast and TMZ was observed.
MediciNova is currently preparing to initiate a Phase 2 clinical trial for the treatment of recurrent Grade IV glioblastoma with University of Sydney Royal North Shore Hospital.
About Glioblastoma
Malignant primary brain tumors represent the most frequent cause of cancer death in children and young adults and account for more deaths than melanoma. 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 55% of all gliomas and has the highest number of cases of all malignant tumors, with an estimated 12,390 new cases predicted for 2017. 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 only approximately 5% of GBM patients survive longer than 36 months.
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 MS and other neurological conditions such as ALS and drug use disorders. 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 amyotrophic lateral sclerosis [ALS], also known as Lou Gehrig’s disease), substance abuse/addiction and chronic neuropathic pain.