European Regulatory Approvals Help CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) Advance ‘Potentially Pivotal’ Study of Novel Brain Cancer Drug

  • Novel brain cancer drug developer CNS Pharmaceuticals is developing a proprietary pharmaceutical candidate called Berubicin for the treatment of glioblastoma multiforme (“GBM”)
  • CNS has received Fast Track designation for Berubicin, which will allow the company more frequent communications with the FDA 
  • CNS has initiated a global potentially pivotal clinical trial to evaluate Berubicin in treating GBM and began dosing patients at sites scattered across several states last year, with numerous additional sites preparing to enroll patients in the coming months
  • CNS is now reporting approval from regulatory authorities in Switzerland and France to proceed with recruiting patients there
  • The study will evaluate more than 200 patients worldwide who have had a recurrence of tumor progression following standard first line therapy
  • The company expects interim results from the study in 2023 after 30 to 50 percent of the total expected patients have reached the six-month point, with a primary completion date in October 2024 and ultimate resolution in February 2025

Biopharmaceutical cancer drug developer CNS Pharmaceuticals (NASDAQ: CNSP) is reporting new advances in its rollout of a global clinical trial the company describes as “potentially pivotal” in producing a treatment for an aggressive brain cancer. 

CNS Pharmaceuticals began recruiting and dosing patients with novel anthracycline drug candidate Berubicin in 21-day cycles last year at locations throughout the United States, and the company is continuing to prepare for recruitment at numerous other U.S. location as well as in Europe (https://ibn.fm/2azMa).

Berubicin is a drug candidate for the treatment of glioblastoma (“GBM”), a brain cancer that is nearly 100 percent fatal just over a year after it’s diagnosed, on average. During the century since GBM was first identified in patients, only four drugs and one device have been approved by the U.S. Food and Drug Administration (“FDA”) to treat it, and none of the treatments have been able to significantly extend patients’ lives beyond “a few extra months,” according to the National Brain Tumor Society (https://ibn.fm/PdGXe).

On April 6, CNS announced that France’s regulatory agencies have granted the company authority to pursue patient recruitment in the country, with approval for the Berubicin study coming from the National Agency for the Safety of Medicine and Health Products (“ANSM”) Competent Authority and from the People Protection Ethics Committee (“EC”) SUD-EST III (CPP Sud-Est III) (https://ibn.fm/BBy5g).

France’s approval comes on the heels of similar authorization in Switzerland, where Swissmedic, the Swiss agency for therapeutic products, joined swissethics, the umbrella organization of the cantonal Ethics Committees (“ECs”), in green-lighting the clinical studies (https://ibn.fm/WfRwB).

“We have said time and again that our number one priority is the advancement of this potentially pivotal study. This is evidenced by our continuous dedication to driving enrollment and bringing global clinical sites on line,” CNS CEO John Climaco stated in the most recent news release. 

More than 200 adult patients will participate in the “adaptive, multicenter, open-label, randomized and controlled study.” The company also hopes to establish sites in Spain and Italy, and plans to report an interim analysis of patients when 30 to 50 percent of them have reached the six-month point on study. 

The excitement behind Berubicin stems from its apparent ability to cross the blood-brain barrier — something unheard of in cancer-fighting anthracyclines. And an initial evaluation of Berubicin’s safety by another company 16 years ago resulted in one patient who emerged cancer-free — surviving well beyond the expected amount of time for people with GBM, and still alive and cancer free as of November 2021. 

Among the other 26 patients included in that initial safety test, 12 achieved some improvement or stabilization of their condition for a period of time, according to the company (https://ibn.fm/aLYwR).

“The data Berubicin has shown to-date demonstrates encouraging promise in treatment of GBM. Patients and families are desperate for a viable treatment option that provides benefit and I look forward to further exploring Berubicin’s potential,” CNS’s national coordinating investigator partner in Switzerland, professor Michael Weller, MD, of the University Hospital Zurich, stated. 

CNS expects a primary completion date of October 2024 for the study, with final completion by February 2025 (https://ibn.fm/mhJ2b).

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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