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 lymphoma with central nervous system involvement (NHL-CNSI)

HOUSTON, 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.

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 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.

About CNS Pharmaceuticals, Inc.

CNS Pharmaceuticals a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system. The Company's lead drug candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications including glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer.

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Forward-Looking Statements

Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. . These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

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