CNS Pharmaceuticals Inc. (NASDAQ: CNSP) Optimistic About Upcoming Berubicin Trials After IND Approval

  • Berubicin is CNS Pharmaceuticals’ lead product candidate for treatment of Glioblastoma Multiforme, and has the potential to be the first anthracycline to cross the blood-brain barrier based on limited results from a Phase 1 trial
  • The market for GBM treatment is estimated to reach $3.3 billion in 2024, growing at a CAGR of 17.4%
  • CNS, in collaboration with sublicensee partner WPD Pharmaceuticals, is currently planning three Berubicin clinical trials, all to start within the year – two Phase II adult trials and a pediatric Phase I trial

Glioblastoma Multiforme (“GBM”) is one of the most aggressive forms of brain cancer in the adult population and is currently considered incurable, with a significant recurrence rate in most patients. Even with gross total resection of the GBM tumor, there is always a microscopic amount of disease that gets left behind. A gross total resection of GBM is defined as removing at least 98% or more of the tumor that has been contrast-enhanced and visible on an MRI.

CNS Pharmaceuticals (NASDAQ: CNSP), 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, hopes to address this issue and improve the lives of GBM patients while also lowering recurrence risks with its lead drug candidate, Berubicin.

Developed by Dr. Waldemar Priebe, Ph.D., the Chairman of the Scientific Advisory Board for CNS Pharmaceuticals, and a Professor of Medicinal Chemistry at the University of Texas MD Anderson Cancer Center, Berubicin appears (based on limited Phase 1 trial results) to be the first anthracycline to cross the blood-brain barrier (“BBB”) in adults, reaching the tumor’s cancerous cells. Anthracyclines are among some of the most effective drugs ever created for cancer treatment. They have various uses within cancer treatments, including breast, stomach, uterine, ovarian, bladder, lung, and hematological malignancies. To date, there has not been any evidence that anthracyclines can cross the BBB.

In December 2020, the U.S. Food and Drug Administration (“FDA”) cleared CNS Pharmaceuticals’ investigational new drug (“IND”) application. This approval enables the company to begin a human trial and ship Berubicin across state lines to clinical investigators.

CNS Pharmaceuticals is optimistic about the three upcoming clinical trials that are scheduled for Berubicin, and is enthusiastic about the first pediatric study that will begin later this year in Poland under the oversight of sublicensee partner WPD Pharmaceuticals. WPD will also be running a concurrent adult Phase II trial in Poland, while CNS Pharmaceuticals will organize a separate randomized, controlled Phase II adult trial beginning in the United States but slated to expand into western Europe.

Commenting on the plans for the Berubicin development program during a podcast interview with Sid Vaidaya and Eric Gershey, CNS Pharmaceuticals CEO John Climaco said, “This is the biggest news we’ve announced since our IPO back in November 2019. Based on that IND approval, we expect, in the next 90 to 120 days, we will go from zero active clinical trials today to three active clinical trials” (https://ibn.fm/4azlQ).

The market for GBM treatment has grown exponentially over the last few years, being expected to reach $3.3 billion by 2024, from $659 million in 2014 (https://ibn.fm/XOkXw). There are multiple companies making progress in this market as a result of increased focus and investment into research and development of GBM therapeutics. With Berubicin’s apparent ability to breach the BBB and the planned Phase I and Phase II trials, CNS Pharmaceuticals is uniquely positioned to capitalize on this market growth and secure a leading role in the sector.

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

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