" class="no-js "lang="en-US"> CNS Pharmaceuticals Continues Ongoing Pivotal Global Trial
Thursday, June 20, 2024

CNS Pharmaceuticals Continues Momentum in Ongoing Potentially Pivotal Global Trial Evaluating Berubicin for the Treatment of GBM with First Patient Enrolled in Switzerland

CNS Pharmaceuticals, a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced that the first patient in Switzerland has been enrolled in the Company’s ongoing potentially pivotal global trial evaluating Berubicin for the treatment of recurrent glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer.

CNS Pharmaceuticals has opened 40 clinical trial sites of the 59 sites selected across the U.S., Italy, France, Spain, and Switzerland. A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have reached the primary endpoint. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

“The active patient enrollment we continue to build across our clinical trial sites in Europe is incredibly encouraging. Our team is laser focused on getting additional clinical trial sites online so that we can continue to advance toward our planned interim analysis, which we expect mid-year 2023. We are continually grateful to the institutions, clinicians and staff that are contributing to the conduct of this trial and are extremely grateful to the patients that choose to participate. There remains a significant unmet need in the treatment of GBM and we remain committed to advancing Berubicin to potentially offer a much-needed therapy for this devastating cancer,” commented John Climaco, CEO of CNS Pharmaceuticals.

Professor Michael Weller, MD, University Hospital Zurich and National Coordinating Investigator for the potentially pivotal study, added, “I believe Berubicin has the potential to play an important role in the treatment of this devastating disease. We are committed to working alongside the CNS Pharmaceuticals team to advance the development of Berubicin and are pleased to commence patient enrollment at our site(s) in Switzerland.”

Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently being evaluated in a potentially pivotal global study evaluating its efficacy and safety in the treatment of GBM. This trial is an adaptive, multicenter, open-label, randomized controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy compared to the standard of care (SOC). The primary endpoint of the study is Overall Survival (OS), a rigorous endpoint that the 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. Results from the trial will compare Berubicin to current SOC (Lomustine), with a 2 to 1 randomization of patients to receive either Berubicin or Lomustine. The recently amended protocol expands eligibility for the study to patients who have received additional treatments as part of the first line therapy for their disease considering advancements in this area. This change was made due to the complexity of new agents introduced as a component of first line therapy, which allows an additional group of patients that can enroll on the study after what may constitute multiple procedures as their initial treatment. For more information about this trial, visit clinicaltrials.gov and reference identifier NCT04762069.

The FDA has granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with them to provide guidance on expediting the development and review process. Additionally, the Company has received Orphan Drug Designation from the FDA which may provide seven years of marketing exclusivity upon approval of an NDA.

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