CNS PHARMACEUTICALS, INC. CNS Pharmaceuticals, Inc. announced an investigator-initiated Phase 1b/2 trial evaluating the Company's novel anthracycline, Berubicin, which will be conducted at the Pomeranian Medical University (PUM) in Szczecin, Poland The primary efficacy endpoint for the study is to evaluate the safety and tolerability of Berubicin in combination with other cytostatic agents and to determine the recommended Phase 2 dose (RP2D) of Berubicin. Patients enrolled in the investigator-initiated Phase 1b/2 study will receive Berubicin in escalated doses in an accelerated model assigning one patient per cohort, which will reduce the number of patients that may be treated with sub-therapeutic doses. The purpose of the dose escalation strategy is to evaluate dose limiting toxicities (DLT) and establish the appropriate dose to utilize into Phase 2 (recommended Phase 2 dose, RP2D).
The initial escalation by 40% in the next cohorts will be based on safety assessments. After completing a treatment cycle, if a patient does not have any DLTs, they can proceed to the next dose level, and additional patients can be enrolled to explore higher doses. If any patient experiences DLT, that dosing cohort will be expanded to 3 patients.
If 2 patients develop DLT, the given dose will be considered toxic and the next cohort will start treatment at a dose reduced by 20%. After considering the data from the Phase 1 clinical trial in patients with CNS gliomas, treatment of patients with CNS lymphomas is planned to start with a higher initial dose of Berubicin (4.8 mg/m(2)). A total of up to approximately 60 patients are planned to be enrolled.
The minimum participation in the study for an individual patient is approximately 21 weeks. After the end-of-treatment follow-up visit, patients will enter a post- study follow-up period of up to 3 years. Berubicin is currently being evaluated for efficacy and safety in the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer, by CNS Pharmaceuticals in an ongoing, potentially pivotal global study.
