CNS Pharmaceuticals has completed the final GMP manufacturing run of its lead candidate Berubicin, which it acquired from Reata Pharmaceuticals and the GMP material has met all specifications.
Samples of the lyophilized drug product were shipped to Intertek Pharmaceutical Services, for final GMP testing. The pilot recrystallization run met all specifications and the initial GMP run passed all specifications; however, it was discovered that one of the standard 10 metals in Heavy Metals Test, bismuth, was not officially validated for that assay. This did not prevent the formulation of the final drug product. Subsequently, heavy metals including bismuth were again tested and met all specifications. Additionally, the Company is continuing large scale production of Berubicin through NCK A/S. The Company intends to utilize this supply of Berubicin for its potential upcoming Phase II clinical trial in Glioblastoma.
"Completing GMP Manufacturing represents another pivotal step in our Berubicin production," said John Climaco, CEO of CNS Pharmaceuticals. "We are excited to continue our productive start to 2020 by completing another manufacturing milestone and look forward to further advancing both the production and clinical development of our lead candidate. We hope to continue our manufacturing success and utilize our supply of Berubicin for upcoming clinical trials and commercial use."
Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. 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.