- The company is scheduled to conduct three clinical trials in 2021 for Berubicin – two Phase II and the first-ever Phase I in pediatric patients
- FDA modified the trial design to designate overall survival as the trial’s primary endpoint
- The market for brain tumor therapies is expected to grow at a CAGR of 10% and reach an estimated $1.6 billion in 2025
CNS Pharmaceuticals (NASDAQ: CNSP), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, announced that it obtained the Food and Drug Administration’s Investigational New Drug (“IND”) approval for its lead drug candidate Berubicin, according to a company press release on December 17, 2020 (https://ibn.fm/2Tin7). The press release was followed a day later by a public conference call during which the company’s CEO John Climaco and CMO Sandra Silberman, M.D., Ph.D. discussed the IND approval, as well as what that means for CNS Pharmaceuticals.
The IND approval will allow the company to move forward with the plans for the Phase II trial of Berubicin in adults with Glioblastoma Multiforme (“GBM”) who have failed first-line therapy. GBM is an aggressive form of brain cancer that…
NOTE TO INVESTORS: The latest news and updates relating to CNSP are available in the company’s newsroom at https://ibn.fm/CNSP
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