MediciNova Successfully Achieves Primary Endpoints in Glioblastoma Treatment Trial
MediciNova, Inc. (Nasdaq: MNOV) has presented new data and results of a Phase 2 clinical trial of MN-166 (ibudilast) in glioblastoma (GBM) patients at the 28th Annual Meeting of the Society for Neuro-Oncology (SNO). The study’s primary endpoints were met, demonstrating the safety and tolerability of an MN-166 and temozolomide (TMZ) combination treatment and efficacy of the combination treatment defined as progression-free survival rate at 6 months using the RANO criteria.
Kazuko Matsuda, M.D., Ph.D., M.P.H., Chief Medical Officer of MediciNova, Inc., commented, “We are very pleased to report the positive safety and efficacy results from the first GBM clinical trial of MN-166. GBM’s rapid progression and resistance to therapy poses a serious challenge to the medical community.
“The preclinical studies presented at this meeting support our postulation that adding MN-166 (ibudilast) to existing therapies, e.g., TMZ, anti-PD1 or anti-PD-L1, improves survival more than the individual therapies alone. We are excited by the findings presented by our esteemed collaborators and look forward to completing the full data analysis from the GBM clinical trial.”
Highlights
MediciNova’s trial enrolled a total of 62 patients, including 36 newly diagnosed GBM patients and 26 recurrent GBM patients. Progression-free survival at 6 months was 44% for new GBM and 31% for recurrent GBM.
The new results and data were presented by MediciNova’s collaborator, Justin Lathia PhD, Co-Director of the Brain Tumor Research and Therapeutic Development Center of Excellence at Cleveland Clinic Lerner Research Institute, and Professor, Department of Molecular Medicine at Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, and Patrick Wen, Director at the Center for Neuro-Oncology at Dana-Farber Cancer Institute, Professor of Neurology, Harvard Medical School.
MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF).
MN-166 is in development for the treatment of ALS (amyotrophic lateral sclerosis), Multiple Sclerosis, DCM (degenerative cervical myelopathy), glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder.
About MediciNova
MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in Long COVID and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants.
