• CNS Pharmaceuticals is currently undertaking a potentially pivotal global study evaluating the efficacy and safety of Berubicin compared with Lomustine administered after first-line therapy for the treatment of recurrent glioblastoma multiforme (“GBM”)
• GBM is an aggressive form of cancer that occurs in the brain or spinal cord
• In the U.S., it affects between 12,000-15,000 new patients annually with a median survival rate of only 14.6 months from its diagnosis
• CNS’s drug development program is targeting the GBM drug market which is expected to expand at a CAGR of more than 4% between 2020 and 2030

On July 24, 2021, pre-clinical stage biotechnology company CNS Pharmaceuticals (NASDAQ: CNSP) received Fast Track Designation from the U.S. Food and Drug Administration (“FDA”) for its Berubicin drug product (https://ibn.fm/fFjF8). Granted to help facilitate the development and expedite the review of drugs being developed to treat serious conditions and fill unmet medical needs, the designation showed the seriousness of Glioblastoma Multiforme (“GBM”), an aggressive form of cancer that occurs in the brain or spinal cord. The Fast Track status came just over a year after the company had received Orphan Drug Designation (“ODD”), which is intended to support the development and review of novel treatments for rare diseases.

GBM is considered one of the most complex, deadly, and treatment-resistant cancers. And although it is regarded as a rare condition, between 12,000 and 15,000 Americans are diagnosed with the condition every year. Even more devastatingly, the National Brain Tumor Society (“NBTS”) estimates that over 10,000 individuals with GBM succumb to the disease annually. 

GBM has a five-year survival rate of only 6.8%, and the average length of survival for patients is estimated to be eight months (https://ibn.fm/NJRpv). Per the NBTS, “survival rates and mortality statistics for GBM have been virtually unchanged for decades,” indicating a treatment gap that CNS intends to fill with its lead product candidate, Berubicin, an innovative anthracycline that appears to cross over the blood-brain barrier and kill tumor cells.

Typical treatment modalities include surgery, which aims to remove as much of the tumor as possible, followed by radiation treatment with chemotherapy. However, a recent article in KPRC’s Click2Houston reads, “GBM can be hard to treat as the tumors often penetrate sensitive areas of the brain responsible for vital neurologic processes, meaning it is not often possible to completely remove a GBM tumor with surgery. GBM grows aggressively within the brain and typically causes progressive neurological symptoms over time.” Additionally, chemotherapy treatment, Dr. Tobias Walbert, a neuro-oncologist, told KPRC2+ in an interview, causes side effects such as nausea and fatigue, which overlap GBM’s symptoms (https://ibn.fm/FQ3gQ).

Against the backdrop of statistics that show the aggressiveness of GBM, CNS is leading the charge to find a potential treatment option for the disease. “In the results of the first Berubicin clinical trial, 44% of the patients showed a clinical response, with one Durable Complete Response (a demonstrated lack of detectable cancer cells),” CNS’s website reads (https://ibn.fm/IKBmv). “Berubicin has shown evidence of improved survival in a patient population that currently has a dismal median survival rate of only 14.6 months from its diagnosis.” 

Currently, the company is focusing on an ongoing, potentially pivotal global study that commenced in March last year. The study is investigating the efficacy and safety of Berubicin compared with Lomustine administered after first-line therapy for the treatment of recurrent GBM. Its primary endpoint is Overall Survival, which, as the company’s website explains, is “a rigorous endpoint that the U.S. FDA has recognized as the basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm.”

The study’s primary completion date is in October 2024, while its estimated completion date is in February 2025 (https://ibn.fm/VJ0JL).

Through its drug development program that includes its potentially pivotal global study, CNS aims to enter the burgeoning GBM global drug market. Analysts at GlobalData PLC estimate that the total sales of GBM treatments, estimated to be $549.1 million in 2020, are set to grow at a CAGR of over 4% between 2020 and 2030 (https://ibn.fm/MoPL3).

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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