Full Press Release Details
Announces Successful Interim Analysis of Efficacy
in Potentially Pivotal Study of Berubicin
recommends continuing clinical trial of Berubicin without modification
to be complete in early Q1 2024
HOUSTON, TX (December 18, 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 the recommendation of the
independent Data Safety Monitoring Board (DSMB) that the Company's ongoing global, potentially pivotal trial of the investigational
agent, Berubicin for the treatment of glioblastoma multiforme (GBM) continue without any modification. The recommendation follows the
DSMB's pre-specified futility analysis of unblinded (to the DSMB only) efficacy and safety data in the Company's trial of
Berubicin versus Lomustine, a standard of care in patients with recurrent GBM. More specifically, the DSMB reviewed the primary endpoint
of overall survival (OS) and secondary efficacy measures progression-free survival (PFF) and overall response rate (ORR), as well as
safety data in evaluable patients. In order to support continuing the trial, Berubicin's efficacy had to be at least comparable
to Lomustine's on the primary endpoint (OS).
"Having successfully reached this milestone,
we believe that this recommendation reflects Berubicin's acceptable efficacy and safety profile, as defined in the trial protocol,
as of the interim analysis. Building on the foundation of strong enrollment laid by our team, our investigators and their patients, the
independent findings of the DSMB add to the Phase 1 trial data, where 44% of treated patients received a clinical benefit of stable disease
or better," said John Climaco, CEO of CNS Pharma. "Finding an effective treatment for GBM remains one of the great challenges
in oncology, and more meaningful options for the many patients who fail first-line therapy are still desperately needed after decades
of research. With this recommendation to continue the study, our long-held belief that Berubicin will ultimately address the unmet clinical
need of GBM patients now moves closer to becoming reality."
The potentially pivotal study of Berubicin is
a 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. Overall Survival is 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.
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).
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 final analysis, the ability to complete enrollment and
the timing thereof, and the ability to commercialize the product even if the trial is successful. 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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