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CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) Moving Forward with Clinical Trials in 2021 after Receiving FDA Approval for IND for Berubicin
December 22, 2020

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) Moving Forward with Clinical Trials in 2021 after Receiving FDA Approval for IND for Berubicin

  • 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 ( 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 grows quickly. The current standard of care for those diagnosed with GBM is surgical resection followed by radiation therapy with temozolomide. There is not a significant increase in the survival rate for those who use this standard of care.

In 2017, CNS entered a collaboration and asset purchase agreement with Reata Pharmaceuticals, Inc. (NASDAQ: RETA) and acquired all the Phase I trial information for Berubicin. Based on the limited information received, Berubicin appears to be the first anthracycline to cross the blood-brain barrier. The Phase I trial of Berubicin was completed by Reata over 14 years ago. One of the Phase I trial participants survived and is living cancer-free. Two others saw a significant reduction of the tumor’s size – up to 80 percent.

CNS holds an exclusive worldwide license to the Berubicin chemical compound. A sub-licensee partner, WPD Pharmaceuticals, will be conducting two trials in Poland during 2021, including the first-ever Phase I pediatric trial of Berubicin. During the conference call, Silberman stated that this trial has expanded to cover additional types of brain tumors, not just GBM, in pediatric patients.

The planned Phase II trial will evaluate the efficacy of Berubicin in patients with GBM who have failed the primary course of treatment for their tumor. The results will compare Berubicin to one standard of care, Lomustine, in a 2 to 1 randomization of patients who will receive one of these drugs. The trial has been designed to allow for the interim analysis of data to demonstrate the differences in the efficacy of the treatments.

One modification made by the FDA for the previously disclosed trial design from CNS is designating the overall survival as the study’s primary endpoint, not just the efficacy. CNS believes that the trial has the potential to provide relevant data to the FDA, which may allow for an expedited pathway to approval for Berubicin. There is, however, no assurance that the FDA will interpret the data as such and approve the expedited pathway or further development.

The IND approval and the upcoming clinical trials can help position CNS Pharmaceuticals as a market leader in the fast-growing sector of brain tumor therapies treatments. The overall global market for brain tumor therapeutics is expected to grow substantially from 2020 to 2025, at a CAGR of 10%. The 2019 market was valued at $1.1 billion and is expected to increase to $1.6 billion in 2025 (

According to John Climaco, CNS Pharmaceuticals will transform the next several months as Berubicin clinical trials begin. “We are entering an area with significant unmet medical need since the current treatment paradigm for GBM remains bleak, as this aggressive and currently incurable form of brain cancer continues to claim high mortality rates. We have a tremendous opportunity ahead of us as we continue our mission to improve patient outcomes for GBM and build on the promising results demonstrated by Berubicin in its Phase 1 clinical trial,” he added.

For more information, visit the company’s website at

NOTE TO INVESTORS: The latest news and updates relating to CNSP are available in the company’s newsroom at

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