The presentation also included data from preclinical studies which evaluated the combination of MN-166 (ibudilast) and anti-PD1 or anti-PD-L1 therapy in GBM models.
The primary endpoints of this Phase 2 clinical trial were safety and tolerability of MN-166 (ibudilast) and temozolomide (TMZ) combination treatment and efficacy of the combination treatment defined as progression-free survival rate at 6 months using the RANO criteria. MN-166 (ibudilast) and TMZ combination treatment was safe and well-tolerated, and no unexpected adverse effects were reported.
The highlights of the presentation are as follows
Phase II clinical trial and immunohistochemistry study
The trial enrolled a total of 62 patients, including 36 newly diagnosed GBM (new GBM) patients and 26 recurrent GBM patients
Study participants mean age at screening was 58.9 years old for new GBM and 59.6 years old for recurrent GBM
39% of patients were female in both groups
94% of new GBM patients and 100% of recurrent GBM patients were Caucasian
All of the subjects received TMZ and MN-166 (ibudilast) treatment
Progression-Free Survival at 6 months (PFS6) was 44% for new GBM and 31% for recurrent GBM
Immunohistochemistry evaluation was performed for the patients whose pre-treatment tumor tissue samples were available from resected tumors at the initial surgery or biopsy to evaluate MIF (macrophage migration inhibitory factor), pERK, Ki67, CD3, CD11b, and CD74
CD3 expression was a good predictor for tumor progression at five months in recurrent glioblastoma subjects treated with MN-166 (ibudilast) and TMZ as subjects with progression had higher CD3 tumor infiltration than subjects with no progression (p
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