Business
CNS Pharmaceuticals Announces Investigator-Initiated Phase 1b/2 Trial to be Conducted at the Pomeranian Medical University in Poland
Study to evaluate Berubicin for the treatment of newly diagnosed and relapsed/refractory primary central nervous system lymphoma (PCNSL) or non-Hodgkin's
About this update from Cns Pharmaceuticals, Inc.
[{"type":"text","content":"Study to evaluate Berubicin for the treatment of newly diagnosed and relapsed/refractory primary central nervous system lymphoma (PCNSL) or non-Hodgkin's lymphoma with central nervous system involvement (NHL-CNSI)\nHOUSTON, Jan. 12, 2023 /PRNewswire/ -- 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 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.\n\n \n \n \n \n \n \n\n \nThe 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.\n\"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.\nPatients 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 ...