CNS Pharmaceuticals, Inc., a biopharmaceutical company specializing in treatments for primary and metastatic cancers of the brain and central nervous system, announced that the company’s GMP manufacturer partner NCK A/S, received a Certificate of Analysis (CoA) for its Active Pharma Ingredient (API), clearing it for use in the production of Berubicin.

As previously announced, CNS signed a contract with NCK A/S for the large-scale production of Berubicin, its lead drug candidate for the treatment of glioma brain tumors. NCK A/S is a GMP manufacturer of complex drugs located in Farum, Denmark, and the previous producer of Berubicin for Reata Pharmaceuticals. NCK A/S production of Berubicin should ensure drug availability through the end of Phase II clinical trials for glioblastoma.

“We believe the execution of this critical manufacturing milestone positions the company advantageously ahead of our expected U.S. Phase 2 trial,” stated John Climaco, CEO of CNS Pharmaceuticals. “Our partnerships have proven instrumental in further progressing the manufacturing process necessary to continue the clinical development of our lead candidate. We look forward to continuing the work underway and to initiating our U.S. Phase 2 trial in Q1 of 2021.”