On January 12, 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, reported 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 (Press release, CNS Pharmaceuticals, JAN 12, 2023, prnewswire.com/news-releases/cns-pharmaceuticals-announces-investigator-initiated-phase-1b2-trial-to-be-conducted-at-the-pomeranian-medical-university-in-poland-301719938.html [SID1234626224]).
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The study, titled "Evaluation of the safety and efficacy of Berubicin in the treatment of central nervous system lymphomas," will be a single center, single-arm, open-label Phase 1b/2 clinical trial assessing the efficacy, safety, and pharmacokinetics of Berubicin in a multidrug treatment regimen for adult patients with newly diagnosed or relapsed/refractory primary central nervous system lymphoma (PCNSL) and non-Hodgkin’s lymphoma with central nervous system involvement (NHL-CNSI). 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.
"Based on the data seen to date, Berubicin has continued to demonstrate an overall safety profile more favorable than other known anthracyclines and we remain encouraged by its potential. We are committed to Berubicin’s continued development as a much-needed oncology tool and are therefore providing the study drug to the PUM for their Phase 1b/2 clinical study. Given the unmet needs and current prognosis for CNS lymphomas, the optimal treatment strategy is to improve overall survival, to which we believe Berubicin can contribute. We look forward to further understanding the potential of Berubicin in this disease and the findings from this study," commented John Climaco, CEO of CNS Pharmaceuticals.
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/m2).
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. For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.
About Berubicin
Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.