The FDA has granted an orphan drug designation to MediciNova Inc.’s MN-166, an adjunctive therapy to temozolomide treatment for patients with glioblastoma.
MediciNova, Inc.’s glioblastoma treatment, MN-166 (ibudilast), has been granted an orphan drug designation by the US Food and Drug Administration (FDA).
"We are very pleased that the FDA has granted orphan-drug designation for MN-166 as adjunctive therapy to temozolomide for the treatment of glioblastoma, a rare cancer with a high recurrence rate and poor prognosis,” Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., said in a recent statement.
In a patient-derived xenograft model, the combination of ibudilast and temozolomide led to improved survival. Specifically, median survival was 114 days (in those treated with combination) compared with the control (100.5 days). Expression levels of macrophage inhibitory factor (MIF) and its receptor, CD74, were also suppressed, and the combination was observed to be well-tolerated.
In addition to glioblastoma, MN-166 has been marketed in Japan and Korea for patients with post-stroke complications and bronchial asthma. MN-166 is also being developed for progressive multiple sclerosis (MS) and other neurological conditions like amyotrophic lateral sclerosis and substance abuse/addiction.
In the progressive MS population, MN-166 slowed the rate of brain atrophy compared with placebo.
The estimated rate of change in the brain parenchymal fraction was -.0010 per year with MN-166 (95% CI, -0.0025 to -0.0013). This rate of change reflected an absolute difference of .0009 per year (95% CI, 0.00004 to 0.0017; P=0.04), or about 2.5 milliliters of less brain tissue lost with ibudilast compared with placebo over the 96 weeks of the study, demonstrating a relative difference of 48%.
Glioblastoma is a rare brain cancer that develops from glial cells (astrocytes and oligodendrocytes). It is characterized by rapid growth and migration into nearby brain tissue, oftentimes resulting in death in the first 15 months after diagnosis.