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CNS Pharma Doses First Patient With Berubicin In Pivotal Study For Brain Cancer Treatment

CNS Pharmaceuticals Inc. (CNSP) announced the dosing of the first patients in its Berubicin clinical development program for the treatment of recurrent glioblastoma multiforme or GBM, one of the most aggressive types of brain cancer.

The company said it continues to drive further patient enrollment with 9 clinical trial sites initiated to-date, and an additional 60 sites selected across the U.S., Italy, France, Spain, and Switzerland expected to initiate imminently.

The FDA recently granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the FDA to expedite the development and review process.

Berubicin is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier currently being evaluated in a global potentially pivotal study evaluating its efficacy and safety. Approximately 243 patients with GBM after failure of standard first line therapy will be randomized in a 2:1 ratio to receive Berubicin or lomustine for the evaluation of Overall Survival, the primary endpoint of the study.

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