• Brain cancer drug developer CNS Pharmaceuticals is finalizing preparations to begin March enrollment of patients in its potentially pivotal Phase 2 trial evaluating its promising lead candidate, Berubicin, for the overall survival improvement of glioblastoma (“GBM”) patients
• Glioblastomas are a type of brain cancer that have continued to elude effective therapy over the past century of investigation, leaving patients with expectations of approximately 15 months of survivability beyond diagnosis and recurrence after surgical removal
• A GBM patient in a small Phase 1 Berubicin safety trial 15 years ago has remained cancer-free and stable as of last November, a hint of Berubicin’s potential
• CNS Pharmaceuticals’ sublicensee partner, WPD Pharmaceuticals, is similarly preparing to launch a parallel Phase 2 adult GBM trial in Poland this year, and plans to begin a Phase 1 trial for malignant gliomas in pediatric patients by the end of the year

Glioblastoma may not be a household word but during 2020 more than 13,000 new diagnoses of the deadly brain cancer were expected to hit home for Americans, according to the National Brain Tumor Society. The service and research-funding organization reports that glioblastoma, or GBM, was first identified in scientific literature a century ago but that only four drugs and one device to treat GBM have been approved by the U.S. Food and Drug Administration (“FDA”) since then, and that none of the treatments have been able to significantly extend patients’ lives beyond a few extra months (https://ibn.fm/t9l9g). This sad fact holds true regardless of access to the best care in the world – even President Biden’s son Beau passed away from GMB, in 2015.

Texas-based biopharmaceutical company CNS Pharmaceuticals (NASDAQ: CNSP) is aggressively pursuing FDA approval for its lead drug candidate, a novel anthracycline and the first anthracycline that appears to be able to cross the blood-brain barrier to combat tumors — stepping up the cancer-fighting potential of the drug class.

CNS’ drug candidate, Berubicin, provides good reason for optimism — it was the subject of a Phase 1 safety trial conducted by Reata Pharmaceuticals approximately 15 years ago and one of the participants in the trial has remained alive and cancer-free as of the most recent evaluation late last year, while two other patients in the small study saw reductions of greater than 25 percent in the size of their tumors, one of which was an 80% reduction (https://ibn.fm/nzFPH).

CNS Pharmaceuticals has taken up the challenge of advancing the development of Berubicin for potential commercialization in treating GBM, an illness that is nearly 100 percent fatal just over a year after it’s diagnosed. Which is why an ongoing survival is so remarkable at the 15-year mark.

CNS has progressed its plans for a world-spanning Phase 2 trial, which will compare Berubicin’s response to the effectiveness level of established chemotherapy drug lomustine in 243 GBM patients. In a Feb. 25 news release, the company noted it was on track to enroll patients across approximately 35 clinical sites in the United States, and that 21 sites were already confirmed and in a start-up process (https://ibn.fm/uwU6D).

The participants for the Phase 2 study will be adult GBM patients with recurrent disease (Grade IV, as measured by the World Health Organization) after the failure of standard first-line therapy. The primary endpoint of the study is to demonstrate overall survival, “a rigorous endpoint the FDA recognizes when a statistically significant improvement can be shown relative to a randomized control arm,” the company states.

Shortly after patient screening begins, dosing will start and CNS’ sublicensee partner, WPD Pharmaceuticals, will initiate a similar Phase 2 multicenter clinical trial of Berubicin in Poland. WPD announced Feb. 24 it had completed an agreement to buy half of the batch of Berubicin manufactured in Europe for CNS by BSP Pharmaceuticals for the trial and was advancing its preparations to obtain final approvals from Polish drug oversight authorities (https://ibn.fm/FMj1y).

WPD’s plans are to not only begin both the Phase 2 adult GBM trial in the first half of the year, but also the first phase of a multicenter clinical trial by the end of the year for children with malignant gliomas — the first significant investigation at the pediatric level.

CNS’ future plans include pre-clinical evaluation of Berubicin for additional cancers of the central nervous system and brain (including other cancers metastatic to the brain), as well as expansion of the drug candidate pipeline for treating such cancers.

The FDA has granted CNS Pharmaceuticals its Orphan Drug designation for Berubicin, which allows the company seven years of marketing exclusivity upon approval of a new drug application (“NDA”). The company anticipates filing for additional patents relating to Berubicin to increase its intellectual property protections.

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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