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 the presentation of updated results from the on-going potentially pivotal study evaluating Berubicin, the Company's novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier, in a randomized, controlled study vs. Lomustine, which has been considered to be a standard of care in this recurrent glioblastoma population. This was a poster presentation at the 29th Annual Meeting of the Society for Neuro-Oncology held November 21-24, 2024 in Houston, TX.
The poster titled, "Update on a Potentially Pivotal Trial CNS-201: A Randomized, Controlled Trial of Berubicin Vs. Lomustine After First-Line Therapy for Glioblastoma Multiforme (GBM)," was presented bySandra Silberman, MD, PhD, Chief Medical Officer of CNS Pharmaceuticals. The presented poster is now available on the Company's website. The data presented at the SNO Annual Meeting include comparative demographics, disposition of patients, MGMT promoter methylation status and safety, showing that the balance between the randomized arms has been maintained through enrollment of 239 patients into the study.
"Berubicin is being evaluated to demonstrate its potential to provide a much needed clinical benefit for GBM patients. Our team continues to make progress advancing this important clinical program toward the finish line and we look forward to reporting the primary data analysis in the first half of 2025," commented Dr. Silberman.
Summary of Updated Results from the Potentially Pivotal Study:
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All patients enrolled show comparable demographics within each arm, including age, gender, race, BSA, and KPS. In addition, patients with unmethylated MGMT comprise approximately 40% in both arms, allowing for a reasonable comparison of efficacy irrespective of the methylation status.
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There is a slightly greater percentage of patients on the Berubicin arm compared to the Lomustine arm that have completed the study (84.7% vs. 78.9%), but a greater percentage of patients on the Lomustine arm have withdrawn from the study (11.0% vs. 19.7%), the most common reasons being patient preference (4.9% vs. 9.2%) and death (1.2% vs. 5.3%).
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All grades of any reported adverse events and those of Grade 3-5 in severity occurring in more than 10% of patients are shown to be relatively similar in the Berubicin and Lomustine arms. A slightly greater percentage of patients with all grades or Grades 3-5 with anaemia, headache, and decrease in neutrophil counts were shown in patients receiving Berubicin, while a significantly greater percentage of patients with a decrease in platelet counts and thrombocytopenia occurred in patients receiving Lomustine.
The primary endpoint of the study is Overall Survival (OS), a rigorous endpoint the FDA has recognized as the basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm.
As previously announced in April 2024, the Company completed enrollment with 252 patients in this study evaluating Berubicin vs. Lomustine for the treatment of GBM. In December 2023, the Company announced the successful completion of its pre-planned interim futility analysis of efficacy and safety and received a recommendation from the independent Data Safety Monitoring Board (DSMB) to continue the study without modification.
CNS Pharmaceuticals expects to report primary analysis data from its potentially pivotal study of Berubicin in the first half of 2025. For more information about this trial, visit clinicaltrials.gov and reference identifier NCT04762069.
The FDA has granted CNS Pharmaceuticals Fast Track Designation for Berubicin, which enables more frequent interactions with the agency for guidance on expediting the development and review process. Additionally, the Company has received Orphan Drug Designation from the FDA for using Berubicin to treat malignant glioma, which may provide seven years of marketing exclusivity upon approval of a New Drug Application (NDA).
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 is 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.
The Company's second drug candidate, TPI 287, is an abeotaxane which stabilizes microtubules and inhibits cell division, causing apoptosis and cell death. Similar to Berubicin, TPI 287 has shown the potential to cross the blood-brain barrier and treat CNS tumors. TPI 287 has been well tolerated in over 350 patients to date, including in clinical trials as a monotherapy and in combination with bevacizumab for the treatment of recurrent glioblastoma, neuroblastoma and medulloblastoma, as well as refractory prostate cancer and melanoma, and in tauopathy disease, which can result in dementia.
For more information, please visit www.CNSPharma.com, and connect with the Company on X, Facebook, and LinkedIn.
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. Forward-looking statements include, without limitation, the timing of the release of the primary analysis data for the potentially pivotal study of Berubicin, the timing of the commencement of the registration study for TPI 287, and the Company's cash runway. 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 market and other conditions and 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, except as required by law.
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SOURCE: CNS Pharmaceuticals, Inc.
