CNS Pharmaceuticals Receives Approval from Competent Authority and Central Ethics Committee in Italy for Potentially Pivotal Global Trial Evaluating Berubicin for the Treatment of GBM

Rhea-AI Summary

CNS Pharmaceuticals, a biopharmaceutical company, announced it has received approval from the Italian Medicines Agency for its global trial evaluating Berubicin, a novel treatment for recurrent glioblastoma multiforme (GBM). The trial, which aims to assess the efficacy of Berubicin compared to the standard treatment Lomustine, is set to include 60 clinical sites across the U.S. and Europe, with 41 already opened. A key interim analysis is planned for Q3 2023, focusing on patient survival rates. CNS has been granted Fast Track Designation and Orphan Drug Designation from the FDA for Berubicin, potentially expediting its development and providing marketing exclusivity. The company emphasizes its commitment to addressing unmet medical needs in treating GBM through this ongoing clinical trial.

Positive

• Approval received from Italian Medicines Agency for Berubicin trial.
• Expansion of clinical trial sites to 60, enhancing patient enrollment.
• Fast Track and Orphan Drug Designations granted by the FDA.

Negative

• None.

Continued advancement of global patient enrollment with approvals and site activations in the U.S., Switzerland, France, Spain and Italy

Enrollment continuing to progress toward an interim analysis expected in the third quarter of 2023

HOUSTON, TX / ACCESSWIRE / April 6, 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 it has received approval from the Italian Medicines Agency ("AIFA") Competent Authority and the A.O.U. Policlinico di Bari Ethics Committee for its ongoing potentially pivotal global trial evaluating Berubicin for the treatment of recurrent glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer.

The Company plans to open its clinical sites in Italy imminently in addition to the previously opened 41 clinical trial sites of the 60 sites selected across the U.S., France, Spain, and Switzerland. 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 with 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 on 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.

"Our team has continued to make dedicated efforts to build momentum and drive patient enrollment in this important clinical trial. We are incredibly pleased to add Italy to our growing portfolio of European countries for this global study. Our team continues to focus on bringing additional clinical trial sites online to further accelerate our patient enrollment and our advance toward our planned interim analysis, which we expect in the third quarter of 2023. We look forward to getting sites up and running in Italy in the near future. We remain dedicated to advancing Berubicin and potentially addressing the unmet need in the treatment of GBM," commented John Climaco, CEO of CNS Pharmaceuticals.

Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently being evaluated in a potentially pivotal global study evaluating its efficacy and safety in the treatment of GBM. This trial 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 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. Results from the trial will compare Berubicin to current SOC (Lomustine), with a 2 to 1 randomization of patients to receive either Berubicin or Lomustine. The recently amended protocol expands eligibility for the study to patients who have received additional treatments as part of the first line therapy for their disease considering advancements in this area. This change was made due to the complexity of new agents introduced as a component of first line therapy, which allows an additional group of patients that can enroll on the study after what may constitute multiple procedures as their initial treatment. 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.

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.

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.

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FAQ

What is the current status of CNS Pharmaceuticals' clinical trial for Berubicin?

CNS Pharmaceuticals has received approval to begin its clinical trial for Berubicin in Italy, adding to its existing sites across the U.S. and Europe.

When is the interim analysis for the Berubicin trial expected?

The interim analysis for the Berubicin trial is expected to occur in the third quarter of 2023.

How many clinical trial sites are planned for the Berubicin study?

There are a total of 60 clinical trial sites planned for the Berubicin study, with 41 already opened.

What designations has CNS Pharmaceuticals received for Berubicin?

CNS Pharmaceuticals has received Fast Track Designation and Orphan Drug Designation from the FDA for Berubicin.

What is Berubicin being tested for?

Berubicin is being tested as a treatment for recurrent glioblastoma multiforme (GBM), an aggressive form of brain cancer.