CNS Pharmaceuticals, Inc. Announces Completion of GMP Manufacturing
February 04, 2020 at 08:00 am EST
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CNS Pharmaceuticals, Inc. announced it has completed the final GMP manufacturing run of its lead candidate Berubicin, which it acquired from Reata Pharmaceuticals, Inc. (Reata), and that the GMP material has met all specifications. Samples of the lyophilized drug product were shipped to Intertek Pharmaceutical Services (Intertek), 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.
CNS Pharmaceuticals Inc. is a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system (CNS). The Company's lead drug candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is in development for the treatment of a number of serious brain and CNS oncology indications, including glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. In addition, the Company is advancing the development of its WP1244/WP1874 drug technology, which utilizes anthracycline and distamycin-based scaffolds to create small molecule agents. The Company is also evaluating the use of WP1244/WP1874 in the treatment of other primary brain and central nervous system cancers, as well as cancers metastatic to the brain including pancreatic, ovarian, and lymphomas.