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CNS Pharmaceuticals (NASDAQ: CNSP) Reaches Milestone with Enrollment of 200 Patients in Ongoing Potentially Pivotal Study of Berubicin with the Treatment of Glioblastoma Multiforme (GBM)
Completion of enrollment of study on track by end of 2023Topline data results from interim analysis also on track to announce by end of 2023HOUSTON, TX /
About this update from Cns Pharmaceuticals, Inc.
[{"type":"text","content":"Completion of enrollment of study on track by end of 2023Topline data results from interim analysis also on track to announce by end of 2023HOUSTON, TX / ACCESSWIRE / September 7, 2023 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) (\"CNS\" or the \"Company\"), 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 200 of the expected 243 patients have now been enrolled in the Company's ongoing potentially pivotal study evaluating Berubicin for the treatment of recurrent GBM, an aggressive and incurable form of brain cancer.This potentially pivotal, global study of Berubicin is an adaptive, multicenter, open-label, randomized controlled study in adult patients with recurrent GBM (WHO Grade IV) after failure of standard first-line therapy and compared to Lomustine as 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. The Company has opened 46 clinical trial sites of the approximately 60 sites selected across the U.S., Italy, France, Spain, and Switzerland.\"As we have noted previously, patient volunteers and their treating clinicians are the backbone of our Berubicin development program. We are deeply sensitive to the fact that these brave patients are facing the battle of their lives and we are forever in their debt for the trust and confidence they and their treating clinicians have in Berubicin and the Company. That 200 such individuals have joined our trial helps to create the robust sample set we have desired from the beginning as we seek to conclusively demonstrate Berubicin's potential. All of us at the Company acknowledge that we simply cannot bring this exciting drug candidate forward without these remarkable patients. Furthermore, we believe the rapid and consistent pace of enrollment is not just remarkable in itself but continues to represent the extraordinarily high level of interest and enthusiasm among our investigators and patients. Addressing this devastating disease continues to be the driving force for our team and we are pleased to achieve this landmark milestone. Importantly...