CPhI Online

CNS completes API pilot manufacturing to take Berubicin closer to clinical trials

28 Jan 2020

Biotech firm CNS Pharmaceuticals said Tuesday it has completed pilot manufacturing of a key active pharmaceutical ingredient for its brain tumor drug Berubicin, taking it closer to clinical trials.

CNS said a pilot run of the recrystallization and lyophilization of the API, Reata had been completed.

Late last year, the US Food and Drug Administration (FDA) agreed in a preclinical submission that CNS could use Reata API as long as it was reprocessed and released under GMP conditions, and that the new lyophilized form of the drug could be used during the upcoming clinical trial.

“We are excited to achieve another important milestone in the development of Berubicin,” stated John Climaco, CEO of CNS Pharmaceuticals. “We look forward to completing both GMP manufacturing processes and release for clinical trials.”

Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs.

Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata.

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