CNS Pharmaceuticals Inc. (NASDAQ: CNSP) Brain Cancer Drug IND Filing Accepted for Review by FDA

December 10, 2020 12:48:01
  • CNS Pharmaceuticals featured in audio broadcast distributed to thousands of syndication points.
  • Berubicin IND accepted for review by FDA
  • Phase 1 trial showed 44% of patients experiencing clinical benefit of stable disease or better
  • Adult Phase 2 trials to commence in Q1 2021

The IND filing for brain cancer drug Berubicin has been accepted for review by the U.S. Food and Drug Administration (“FDA”), reports CNS Pharmaceuticals (NASDAQ: CNSP), the company now responsible for the drugs’ development. That news was featured in a recent syndicated NetworkNewsAudio (“NNA”) broadcast, which covered CNS Pharmaceuticals’ recent submission of an Investigational New Drug (“IND”) application to the FDA for Berubicin. The broadcast also detailed the company’s plans to commence adult Phase 2 trials of the drug during the first quarter of 2021.

Since review of the IND application has not been completed, it may seem a little strange that CNSP is already looking ahead to Phase 2 clinical trials. However, Berubicin has already been the subject of Phase 1 trials, which are focused on finding the safest effective dose of a drug. In 2006, Reata Pharmaceuticals, a clinical-stage biopharmaceutical company conducted clinical trials that have had quite encouraging results.

Fortuitously, 11 of the 25 cancer patients who were treated with Berubicin and were available for evaluation in those initial clinical trials “experienced a statistically significant improvement in progression-free survival” ( Moreover, “one patient experienced a durable complete response, which is defined by the National Cancer Institute as the disappearance of all signs of cancer in response to treatment.” This means that that patient has suffered no recurrence and has remained cancer free for more than 13 years. Two other patients saw reductions in tumor size of up to 80%.

Berubicin has been developed to treat glioblastoma multiforme (“GBM”), an aggressive form of brain cancer currently considered incurable. The drug is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs. Anthracyclines are also effective against more types of cancer than any other class of chemotherapeutic agents. They are designed to utilize natural processes to induce deoxyribonucleic acid (“DNA”) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. In effect, Berubicin prevents cancerous cells from replicating.

The Phase 2 clinical trials will be conducted in conjunction with WPD Pharmaceuticals Inc. Additionally, there are plans afoot for WPD Pharmaceuticals to commence a first-ever Phase 1 trial with children in the near future. This pediatric trial will be conducted at Children’s Memorial Health Institute, the largest pediatric hospital in Poland.

CNSP is a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system. In June 2020, the company hired U.S.-based Pharmaceutics International Inc. (“Pii”) and Italian BSP Pharmaceuticals S.p.A. (“BSP”) to handle production of the drug. Synthesis of the Berubicin Active Pharmaceutical Ingredient (“API”) had already been completed, and the API has been delivered to the two manufacturing entities; both have now prepared an injectable form of Berubicin to be used in the clinical trials.

With the production process fully underway, the company is a step closer to getting its IND approved by the FDA. With this dual-track approach to manufacturing, the company reduces the risk of failing to meet its clinical timeline. Moreover, situating production in Europe as well as the United States provides localized availability of Berubicin for the upcoming Phase 1 pediatric and Phase 2 adult studies in Poland and the U.S. Phase 2 trials.

Glioblastoma is one of the most aggressive primary brain cancers in adults, with approximately 13,000 new patients diagnosed each year in the U.S.—the highest diagnosis rate of all malignant brain tumors. An effective way of fighting this pernicious affliction is sorely needed.

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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