CNS Pharmaceuticals Completes Pilot Manufacturing Steps Pursuant to FDA Pre-IND Guidance

CNS Pharmaceuticals announced that Anthem Biosciences of Bangalore, India (Anthem) has completed a pilot run of the recrystallization of the Reata Pharmaceuticals, Inc. API (Reata). It has also completed a lyophilization of the API. Samples of the drug product, which include 299 capped vials, have been shipped to Intertek Pharmaceutical Services (Intertek) for further analysis and release.

As previously announced, the 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 product could be used during the Company’s upcoming clinical trial. Anthem, a full-service provider of GMP manufacturing for APIs, completed this pilot run of the Reata API. The pilot run recrystallization passed all specifications at Intertek. The recrystallized API was shipped to Lyophilization Technology, Inc. a leader of GMP lyophilization of Drug Products for clinical trials, which completed a pilot lyophilization. The pilot run of lyophilized API was successfully tested and released by Intertek. DavosPharma, a Davos Chemical Company, acted on behalf of the Company as the coordinating manufacturing broker for all of these processes.

“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.”