On November 21, 2019 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, reported a Pre-IND meeting request for Berubicin for IV for the Treatment of Glioblastoma Multiforme to the US Food and Drug Administration Division of Oncology Products 2, Center for Drug Evaluation and Research (Press release, CNS Pharmaceuticals, NOV 21, 2019, View Source [SID1234551602]).
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In its request, the Company outlined its rationale for the continued investigation of the compound and detailed key questions for the FDA, including its permission to utilize the supply of Berubicin acquired from Reata Pharmaceuticals Inc. in the planned upcoming Phase II clinical trial. The company has performed a preliminary purity testing and analysis on Reata’s supply of Berubicin and verified that it is 99.9% pure.
"We believe that utilizing the supply of Berubicin we acquired from Reata could offer the Company significant costs savings and eliminate the excess risk and time associated with manufacturing complex drugs," stated CEO of CNS, John M. Climaco.
About Berubicin
Berubicin is an anthracycline, a class of drugs among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of the topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin was developed at the MD Anderson Cancer Center (MDACC), the world’s largest cancer research facility. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer.