InvestorWire NewsRoom

Article

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) Marks Significant Milestone in Pursuit of Berubicin Approval for Global GBM Treatment, Raises $11.5 Million from Private Placement
January 25, 2022

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) Marks Significant Milestone in Pursuit of Berubicin Approval for Global GBM Treatment, Raises $11.5 Million from Private Placement

  • CNS Pharmaceuticals received approval from swissethics for its potentially pivotal study of Berubicin, a novel anthracycline for the treatment of Glioblastoma Multiforme (“GBM”)
  • The approval is the first from a European Ethics Committee
  • The company, which dosed the first patients in its Berubicin program in September, has selected multiple clinical sites across the U.S., Spain, France, Italy, and Switzerland
  • CNS recently closed an $11.5 million private placement
  • It intends to use the net proceeds to fund its clinical trials and preclinical programs, other R&D programs, and for general corporate purposes

Clinical stage biotechnology company CNS Pharmaceuticals (NASDAQ: CNSP) is celebrating a significant milestone as it journeys toward its potentially pivotal study of Berubicin for the treatment of Glioblastoma Multiforme (“GBM”). The company announced December 2 that it had received approval from swissethics, the umbrella organization of the cantonal Ethics Committees in Switzerland (https://ibn.fm/NisfL).

The first from a European Ethics Committee, the approval partly fulfills CNS’s goal of seeing Berubicin approved for the potential treatment of GBM globally. “This terrible disease does not discriminate on the basis of geography or anything else: Patients in Europe are as desperate as patients in the United States, and treating patients is not only why we do what we do, but how we do it as well. Driving patient enrollment is how we advance Berubicin’s development, and opening additional clinical sites around the globe is the pivotal piece that allows us to ramp up our efforts and move toward data,” stated CNC Pharmaceuticals CEO John Climaco.

So far, the company has selected tens of clinical sites across the United States, Spain, France, Italy, and Switzerland. In addition, CNS has already dosed the first patients in its Berubicin clinical development program, with a September 30, 2021 announcement noting that additional patient enrollment, randomization, and dosing was well underway in the United States (https://ibn.fm/qI7q2). 

Berubicin mid last year received the U.S. Food and Drug Administration (“FDA”) Fast Track Designation as well as an Orphan Drug Designation (https://ibn.fm/PSSiU). Notably, the former designation helps facilitate the development and expedited review of drugs with the potential of treating serious conditions with high unmet medical needs, thereby underlining the seriousness of GBM, one of the most aggressive, deadly, and treatment-resistant cancers that form in the brain.

While chemotherapy medications are usually prescribed to patients living with the condition, results are underwhelming, if not devastating. According to CNS, the current standard of care is ineffective in about 60% of patients.

GBM is the most common malignant brain and central nervous system tumor accounting for 47.7% of all cases, according to data from the American Association of Neurological Surgeons (“AANS”). Its prevalence within a population of 100,000 people stands at 3.21. But despite this low incidence rate, the disease is lethal – only 40% of patients survive in the first year after diagnosis and 17% in the second year. Moreover, it can cause death in six months or less (https://ibn.fm/wU6vY).

In this regard, the recent approval, as well as CNS’s dosing efforts, offer a robust foundation for a potentially pivotal global trial. 

The adaptive, multicenter, open-level, randomized, and controlled study will evaluate Berubicin in adult patients with recurrent GBM (WHO Grade IV) after failure of standard first-line therapy. About 243 patients with GBM after failure of standard first-line therapy will be randomized in a 2:1 ratio to receive Berubicin or lomustine, a chemotherapy drug, in order to evaluate overall survival, the primary endpoint of the study.

It is noteworthy that Berubicin is the first anthracycline to cross the blood-brain barrier. It evidences effectiveness in treating GBM. “[Anthracycline] is a classic drug that’s been around for 60 years. It’s the first line therapeutic for all sorts of difficult-to-treat cancers. But no one has been able to get a drug like this across the blood-brain barrier until our Founder modified the classic anthracycline molecule to be more effective in crossing the blood-brain barrier,” said Climaco during an October interview with Proactive (https://ibn.fm/EJjMb).

Meanwhile, CNS Pharmaceuticals recently closed a previously announced private placement, priced at-the-market under Nasdaq rules, of over 12,105,264 shares of common stock (or pre-funded warrants in lieu thereof), raising gross proceeds of $11.5 million (before deductions). CNS intends to use the net proceeds to fund its clinical trials and preclinical programs, other R&D operations, and for general corporate purposes (https://ibn.fm/aTRJE).

For more information, visit the company’s website at www.CNSPharma.com.

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

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 https://www.InvestorWire.com

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

InvestorWire (IW)
8033 Sunset Blvd Suite 1037-IW
Los Angeles, CA 90046
310.299.1717 Office
www.InvestorWire.com
[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.

(310) 299-1717

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).