On January 12, 2023 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 Phase 2 clinical trial evaluating MN-166 (ibudilast) in recurrent and newly diagnosed glioblastoma conducted at Dana-Farber Cancer Institute has completed enrollment (Press release, MediciNova, JAN 12, 2023, View Source [SID1234626223]). This Phase 1/2 clinical trial was divided into a dose-escalation phase (Part 1) followed by a fixed-dose phase (Part 2). Part 1 evaluated the safety and tolerability of an escalating dose of MN-166 (ibudilast) when given in combination with temozolomide (TMZ) and determined a safe and tolerable dose of MN-166 (ibudilast) to be used in Part 2 of the study. Part 2 will evaluate the efficacy of MN-166 (ibudilast) and TMZ combination treatment. Tumor tissues were obtained from the initial surgery or biopsy. We evaluated the correlation of MN-166 and TMZ combination therapy to clinical outcomes and tumor tissue analysis findings.
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Preliminary tumor tissue analysis and clinical outcome findings from Part 1 participants will be presented at the 20th Annual World Congress of SBMT (Society for Brain Mapping and Therapeutics) to be held February 16 – 19, 2023.
Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc., commented, "We have completed enrollment and are actively treating the remaining patients in Part 2 of the trial. We look forward to reporting the interesting findings from tumor tissue analysis and clinical outcomes at the 20th Annual World Congress of SBMT, including potential predictors of treatment response to MN-166 plus TMZ combination therapy in glioblastoma. We will release more information after SBMT meeting."
About Glioblastoma
According to the American Association of Neurological Surgeons, glioblastoma is an aggressive brain cancer that often results in death during the first 15 months after diagnosis. Glioblastoma develops from glial cells (astrocytes and oligodendrocytes), grows rapidly, and commonly spreads into nearby brain tissue. Glioblastoma 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 glioblastoma represents about 15% of all primary brain tumors and approximately 10,000 cases of glioblastoma are diagnosed each year in the U.S. 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 glioblastoma. Median survival is about 11-15 months for adults with more aggressive glioblastoma (IDH-wildtype) who receive standard treatment of surgery, temozolomide, and radiation therapy.
About MN-166 (ibudilast)
MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).