CNS Pharmaceuticals, Inc. (NASDAQ: CNSP), a US-based biopharmaceutical company, announced on Thursday that it is conducting an investigator-initiated Phase 1b/2 trial assessing the firm's novel anthracycline, Berubicin at the Pomeranian Medical University (PUM) in Szczecin, Poland.

The study is titled 'Evaluation of the safety and efficacy of Berubicin in the treatment of central nervous system lymphomas'. It is a single centre, single-arm, open-label Phase 1b/2 clinical trial evaluating the efficacy, safety, and pharmacokinetics of Berubicin in a multidrug treatment regimen for adult subjects 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 study's primary efficacy endpoint is to assess the safety and tolerability of Berubicin in combination with other cytostatic agents and to determine the recommended Phase two dose (RP2D) of Berubicin.

The subjects enrolled in the investigator-initiated Phase 1b/2 study are to receive Berubicin in escalated doses in an accelerated model assigning one patient per cohort that will reduce the number of patients that are likely to be treated with sub-therapeutic doses. The aim of the dose escalation strategy is to assess dose limiting toxicities (DLT) and establish the appropriate dose for use into Phase two (recommended Phase two dose, RP2D).