Company continues to execute on rapid progression of enrollment toward planned interim analysis expected in the third quarter of 2023
45 clinical trial sites of the 60 sites selected across the U.S., Italy, France, Spain, and Switzerland open and enrolling patients
HOUSTON, TX / ACCESSWIRE / May 25, 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, today announced that its ongoing potentially pivotal study evaluating Berubicin for the treatment of recurrent glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer, has enrolled 134 patients, representing more than 50% of the total planned enrollment for the study.
"The achievement of this milestone in any study is no small feat. The dedication of our team and the proficiency of their operational execution continues to be shown by reaching over 50% of the total planned enrollment in our study. This is an important step that brings us closer to providing a potential treatment option to patients with GBM and addressing this disease, which remains a significant unmet need. We are focused on continuing this momentum towards the interim analysis for the study, which remains on target for the third quarter of this year," commented John Climaco, CEO of CNS Pharmaceuticals.
This potentially pivotal global study is an adaptive, multicenter, open-label, randomized controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy compared to lomustine as the standard of care (SOC). The primary endpoint of the study is Overall Survival (OS), a rigorous endpoint that 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.
A pre-planned, non-binding futility analysis will be conducted by an independent Data Safety Monitoring Board (DSMB) to recommend whether this study should continue as planned based on Berubicin showing value as a second-line treatment for patients with glioblastoma compared to Lomustine. The Company will conduct this analysis after at least 50% of the patients in the population to be analyzed for the interim analysis (30-50% of the total number of patients for this trial) can be evaluated as having failed the primary efficacy endpoint (death). The DSMB will review the number of deaths in each arm to ensure that the overall survival of patients receiving Berubicin shows at least a statistically significant comparability to those receiving Lomustine. Additional analyses that will be provided based on this data will be comparisons of secondary endpoints, including progression-free survival (PFS), response rates, and safety assessments. Enrollment will not be paused during this interim analysis.
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 them to provide guidance on expediting the development and review process. Additionally, the Company has received Orphan Drug Designation from the FDA which may provide seven years of marketing exclusivity upon approval of an NDA.
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.
For more information, please visit www.CNSPharma.com.
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 in this press release include, without limitation, the Company's timing of the interim analysis to occur in the third quarter of 2023, and the ability to continue to open additional clinical trial sites on a timely basis. 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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SOURCE: CNS Pharmaceuticals, Inc.