CNS Pharmaceuticals announces primary analysis of berubicin in GBM

CNS Pharmaceuticals (CNSP) announced the primary analysis of its clinical trial evaluating Berubicin, the first anthracycline demonstrated to extensively cross the blood-brain barrier, for the treatment of recurrent or progressive Glioblastoma Multiforme an aggressive and usually fatal brain cancer. This analysis did not demonstrate statistically significant superiority in overall survival, the primary endpoint. However, although the trial was not powered to determine non-inferiority, the data appear comparable in clinically important endpoints in all patients, including those with the most unfavorable tumor markers. Additionally, patients experienced no cardiotoxicity, a risk that curtails the use of other anthracyclines, and the safety profile continues to be favorable in this patient population. The trial compared Berubicin to Lomustine, a current standard of care in recurrent or progressive GBM. The protocol design incorporated the importance of patient phenotype, utilizing well recognized biostatistical techniques in both a pre-specified futility analysis and this analysis. The data appear comparable to Lomustine in important clinically relevant endpoints, including overall survival and progression free survival across all patients treated with Berubicin. Further, the aggregate data facilitate multiple additional clinical analyses for informed hypothesis generation.