CNSP - CNS Pharmaceuticals gets Spanish regulatory nod for brain cancer study

CNS Pharmaceuticals (NASDAQ:CNSP) said on Thursday that it received approval from Spanish drugs regulator AEMPS and Spanish ethics committee CElm Provincial de Sevilla to conduct a study of Berubicin to treat recurrent glioblastoma multiforme (GBM), an aggressive type of brain cancer. The Spanish approvals come after CNSP got similar approvals for the study from French and Swiss regulators earlier this month. The study will enroll ~243 patients with GBM after failure of standard first line therapy. The patients will be randomized in a 2:1 ratio to receive Berubicin or chemotherapy drug lomustine for the evaluation of overall survival, the main goal of the study. "We continue to build momentum in our potentially pivotal study of Berubicin, and importantly advance toward bringing a much needed treatment option to patients. We have significantly bolstered our international presence and we are grateful to Spain for joining us in support of this trial," said CNSP CEO

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CNS Pharmaceuticals gets Spanish regulatory nod for brain cancer study