CNS Pharmaceuticals Inc. (CNSP) said Thursday that the US Food and Drug Administration has approved the Investigational New Drug or IND application for the company's lead product candidate, Berubicin, for the treatment of Glioblastoma Multiforme or GBM.
Glioblastoma multiforme is an aggressive and incurable form of brain cancer.
The company said it will initiate its phase 2 trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with Glioblastoma Multiforme who have failed first-line therapy.
Following correspondence between the company and the FDA, the company has modified the previously disclosed trial design, including designating overall survival as the primary endpoint of the study, CNS Pharma said.
Overall survival is a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm.
In Thursday pre-market trade, CNSP was trading at $2.84, up $0.66 or 30.28 percent.
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