- Glioblastoma (“GBM”), an aggressive and generally fatal brain cancer, has attracted attention as a significant unmet medical need because of its incurability, claiming the lives of more than 200,000 patients worldwide each year
- CNS Pharmaceuticals is in the middle of a potentially pivotal global Phase 2 clinical trial for its drug candidate, a novel anthracycline called Berubicin that is apparently unique in its ability to cross the blood-brain barrier to target central nervous system tumors
- CNS’s clinical trial sites have begun enrolling patients in the United States, France, Spain and Switzerland, with sites prepared to receive patients in Italy as well
- CNS has received fast-track and orphan drug recognition for Berubicin from the FDA, helping the company to streamline its path to potential commercialization, and CNS is also preparing to apply for orphan drug designation in the European Union
- CEO John Climaco reported on company developments at the Virtual Investor GBM Spotlight Event on April 4
For decades, medical science has sought an effective means of stopping the most common primary brain cancer in adults in its tracks and keeping it from recurring. In spite of multimodal treatment that includes surgical removal, radiotherapy and chemotherapy, glioblastoma tumors remain the deadliest form of brain cancer and are essentially incurable, leaving patients with a median life expectancy of about 15 months.
The field of contenders for solving this unmet medical need is competitive, with experimental clinical research introducing options that range from using magnetically controlled carbon nanotubes in nanosurgery to immunotherapy to cancer-killing cell therapies.
CNS Pharmaceuticals (NASDAQ: CNSP) is using its novel anthracycline Berubicin in an ongoing, potentially pivotal, global Phase 2 trial that expects to enroll more than 200 patients at sites that currently include clinics in the United States, France, Spain, Switzerland and Italy, with primary completion of the study next year and final results of the study in early 2025 (https://ibn.fm/G7G2w).
Anthracyclines are a class of chemotherapy agents used to treat other cancers for decades, but anthracyclines’ inability to cross the blood-brain cellular barrier to target brain tumors has been a limiting factor in central nervous system ailments.
Berubicin appears to have a unique ability to cross the blood-brain barrier to attack glioblastoma (“GBM”) tumors where they reside, and the ongoing trial is seeking to establish an improvement in the overall survivability (“OS”) of GBM patients using Berubicin. It follows on prior clinical trials that demonstrated the novel anthracycline’s safety in human patients and potential effectiveness against lab cells, as well as evidence of improved OS over the median rate (https://ibn.fm/6y0YZ).
Berubicin is being evaluated as a second-line treatment to stop tumor recurrence following on initial efforts to stop GBMs through surgical removal and targeted radiation therapy to eliminate as much of the cancer as possible. It has been granted fast-track status with Orphan Drug Designation (“ODD”) by the U.S. Food and Drug Administration (“FDA”).
The company is seeking similar ODD status in the European Union, which would grant a decade of IP protection in those countries.
A decrease in the size of GBM tumors, a halt to the growth of tumors, and / or an extension of the time the tumors take to progress will be regarded as favorable outcomes of the trial. When Berubicin was initially developed by Reata Pharmaceuticals in 2006, a small-scale safety study helped establish the drug’s safety but also resulted in one patient emerging cancer-free and nearly half the other patients showing statistical improvement in their conditions, leading CNS Pharmaceuticals to take up the challenge of continuing to test Berubicin’s potential for commercial availability in 2017 (https://ibn.fm/YLnla).
CNS has a strong balance sheet for executing its trial development strategy for achieving clinical and regulatory milestones. The company reported a cash balance of about $7 million in September, which was then supplemented by a $6 million public offering in late November.
CEO John Climaco reported on GBM’s unmet medical need and CNS’s progress in battling it at the Virtual Investor GBM Spotlight Event on April 4, with a live video webcast of the event (https://ir.cnspharma.com/news-events/ir-calendar/detail/2795/virtual-investor-gbm-spotlight-event).
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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