InvestorWire NewsRoom


CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) Moving Forward with New Berubicin Clinical Trials, Determined to Help Address Unmet Needs of GBM Patients
January 13, 2021

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) Moving Forward with New Berubicin Clinical Trials, Determined to Help Address Unmet Needs of GBM Patients

  • IND approval from the FDA has given CNS Pharmaceuticals the green light needed to continue with clinical research of Berubicin in patients suffering from GBM and other brain/nervous system cancers
  • Company holds the exclusive worldwide license for Berubicin, the first anthracycline to cross the blood-brain barrier in the adult brain
  • The GBM therapeutics market is expected to increase to an estimated $3.3 billion in 2024
  • CNS Pharmaceuticals’ sublicensee will be conducting the first pediatric study using Berubicin

CNS Pharmaceuticals (NASDAQ: CNSP) is a clinical-stage biotechnology company that is currently specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, including the use of Berubicin for patients with glioblastoma multiforme (“GBM”), an aggressive form of brain cancer that is incurable. CNS is currently working on the development and clinical trials of Berubicin for GBM and the potential of addressing other central nervous system malignancies.

Berubicin appears to be the first anthracycline to cross the blood-brain barrier in the adult brain. Its development started over 15 years ago when Reata Pharmaceuticals, Inc. (NASDAQ: RETA) conducted the first Phase I trial, creating limited clinical data. Phase I trial results indicated that 44 percent of participants reported a significant improvement in the size of the tumor. The evidence concluded that there was a positive enough impact that CNS has continued with the development and the clinical-stage trials for the drug.

CNS holds the exclusive license for Berubicin worldwide. The company goes into the year 2021 determined to move forward with the development and distribution of Berubicin for GBM. The recent approval of the United States Food and Drug Administration (“FDA”) of Berubicin as an investigational new drug (“IND”) has only increased the opportunity for CNS to move forward with the three clinical trials currently in development.

“The company will transform within the next several months as Berubicin becomes the subject of up to three active clinical trials, which include our randomized, controlled Phase II trial in the U.S., and two trials planned by our sublicensee WPD in Poland,” CNS Pharmaceuticals CEO John Climaco said during a recent virtual presentation discussing the FDA IND approval and future company plans (

The company’s sublicensee WPD Pharmaceuticals (CSE: WBIO) (FSE: 8SV1) will be conducting a Phase II trial in adults, as well as the first-ever Phase I trial in children who suffer from GBM and other cancers of the brain and central nervous system. This is the first pediatric trial of its kind.

According to Climaco, CNS aims to address the significant unmet medical need of GBM patients since the current treatment paradigm for the condition yields bleak results, and this aggressive and, as yet, 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.

The GBM treatments market is anticipated to increase to an estimated $3.3 billion in 2014, marking a CAGR of 17.4% from 2014, when the market was $659. The growth is expected to be driven by seven major markets – the United States, Spain, the UK, France, Italy, Japan, and Germany, and is the direct result of the growing unmet needs of the current market (

Berubicin is currently being produced in two labs as a result of a dual-track manufacturing strategy implemented by CNS. To ensure that current conditions do not hinder the progress of Berubicin’s development and availability, CNS has turned to United States-based Pharmaceuticals International Inc. and Italy-based BSP Pharmaceuticals SpA for the production of Berubicin for the clinical trials. Both pharmaceutical companies have diversified the supply chain, and increased the availability of Berubicin, mitigating the risks of COVID-19 in clinical trial strategies.

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

About InvestorWire

InvestorWire is the wire service that gives you more. From regional releases to global announcements presented in multiple languages, we offer the wire-grade dissemination products you’ll need to ensure that your next press release grabs the attention of your target audience and doesn’t let go. While our competitors look to nickel and dime you with hidden fees and restrictive word limits, InvestorWire keeps things transparent. We offer UNLIMITED Words on all domestic releases. While other wire services may provide a basic review of your release, InvestorWire helps you put your best foot forward with complimentary Press Release Enhancement.

With our competitors, the work is done the second your release crosses the wire. Not with InvestorWire. We include follow-up coverage of every release by leveraging the ever-expanding audiences of the 50+ brands that make up the InvestorBrandNetwork.

Get more out of your next press release with InvestorWire. It’s unlike anything you’ve seen before.

For more information, please visit

Please see full terms of use and disclaimers on the InvestorBrandNetwork website applicable to all content provided by IBN, wherever published or re-published:

InvestorWire (IW)
8033 Sunset Blvd Suite 1037-IW
Los Angeles, CA 90046
310.299.1717 Office
[email protected]

InvestorWire is part of the InvestorBrandNetwork.

Get Started with InvestorWire

To distribute a release in the next 24 hours. Contact our client services team.

(862) 930-1404

Distribute a press release. Submit your release to get started.

Submit Press Release

Set up a Live demonstration. Schedule a date and time that works for you.

Schedule a LIVE Demo

Press Distribution

Explore Press Distribution Solutions

All releases include an unlimited word count* with full wire-grade syndication, our press release enhancement service, and a follow-up InvestorNewsBreak article distributed to thousands of editorial syndication partners.

Discover Add-on Solutions

Increase the impact of your achievements by adding these exclusive solutions from InvestorWire, delivered in conjunction with the InvestorBrandNetwork (IBN).