Company continued to see rapid progression and acceleration of enrollment with 180 patients enrolled to date across 46 clinical trial sites, globally

Completion of enrollment of study expected by end of 2023

Company has documented the necessary number of patients reaching the primary efficacy endpoint (overall survival) to conduct pre-planned interim analysis

Topline data from interim analysis expected before year end

HOUSTON, TX / ACCESSWIRE / August 3, 2023 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary metastatic cancers in the brain and central nervous system, today provided a clinical update for its ongoing clinical study evaluating Berubicin for the treatment of recurrent GBM, an aggressive and incurable form of brain cancer.

This potentially pivotal, global study of Berubicin is an adaptive, multicenter, open-label, randomized controlled study in adult patients with recurrent GBM (WHO Grade IV) after failure of standard first-line therapy and 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.

Enrollment Update - Full Enrollment of the Potentially Pivotal Study Expected by Year End

The Company has opened 46 clinical trial sites of the approximately 60 sites selected across the U.S., Italy, France, Spain, and Switzerland. The Company is announcing today that the first clinical trial site in Italy has been activated and the enrollment and dosing of the first patient in Italy has taken place.

To date, 180 patients of the expected 243 patients have been enrolled in the study.

Recent Enrollment Highlights

• Reached 74% enrollment in study;
• Pace of enrollment is rapidly accelerating with the first 75 patients taking 18 months to enroll while the second 75 patients took less than 6 months to enroll;
• Enrolled 25 patients in June; and
• Expanded study with commencement of enrollment and dosing in Italy.

"Enrolling patients in an orphan disease trial is always a challenge, and that's why we are thrilled with the rate of enrollment in this potentially pivotal study. The robust interest and enthusiasm among our investigators and patients reflect the pressing need to develop treatment options for patients with GBM. Addressing this devastating disease continues to be the driving force for our team," commented John Climaco, CEO of CNS Pharmaceuticals.

Pre-Planned Interim Analysis Update - Company Expects Interim Analysis by Year End

Mr. Climaco added, "We have now reached the number of events that enables us to conduct the pre-planned interim analysis, which is the comparative assessment of deaths expected in this study based on historical Lomustine data. Reaching this inflection point in the study has taken longer than initially anticipated because many patients in this study are living longer than the historical data would suggest they should. Of course, without data from our study in hand yet, we cannot know whether either Berubicin or Lomustine is the cause of longer survival, and consequently there is no basis at this time for drawing any conclusions about the results of the study. Regardless of the cause of the observed longevity, it is an exciting outcome for patients and their families. We are diligently working with our CRO on the interim analysis activities and expect to report topline data from the interim analysis before year end."

Professor Michael Weller, MD, Chairman of the Department of Neurology at the University Hospital in Zurich, Switzerland and the National Coordinating Investigator for CNS Pharmaceuticals' potentially pivotal study, added, "For decades, treating patients with GBM has been extremely difficult. We are constantly challenged by the lack of solutions and our desire to offer hope to patients and their families. I am thrilled to be part of the Berubicin clinical study and am hopeful that we are one step closer to providing a critical piece missing from our treatment armamentarium for GBM."

As noted above, the Company has now reached the criteria required by the study protocol to conduct a pre-planned, non-binding futility analysis, which an independent Data Safety Monitoring Board (DSMB) will review to determine whether to recommend continuing the study as planned based on Berubicin showing potential value as a second-line treatment for patients with glioblastoma. CNS previously reported that the Company would 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) had reached the primary efficacy endpoint, as provided for in the study protocol. 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 will include comparisons of secondary endpoints, including progression-free survival (PFS), response rates, and safety assessments. The Company is confident it will announce the results from the interim analysis publicly before the year end. Enrollment will continue during the 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 the agency for 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.

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.

For more information, please visit www.CNSPharma.com, and connect with the Company on Twitter, 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 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.

CONTACTS:

Investor Relations Contact

JTC Team, LLC
Jenene Thomas
833-475-8247
CNSP@jtcir.com

SOURCE: CNS Pharmaceuticals, Inc.