CNS Pharmaceuticals Announces First Patient Enrolled in Spain in Ongoing Potentially Pivotal Global Trial Evaluating Berubicin for the Treatment of GBM

Rhea-AI Summary

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) has announced the enrollment of the first patient in Spain for its global trial evaluating Berubicin for treating recurrent glioblastoma multiforme (GBM). The trial, which aims to assess Berubicin's efficacy and safety, has opened 37 of the 59 planned clinical sites across several countries, including the U.S., Italy, France, Spain, and Switzerland. An interim analysis is expected mid-2023 after 30-50% of subjects reach the primary endpoint. The FDA has granted Berubicin Fast Track and Orphan Drug Designations, enhancing its development process and potential market exclusivity.

Positive

• Enrollment of the first patient in Spain for the pivotal trial of Berubicin.
• 37 of 59 planned clinical trial sites are now open across multiple countries.
• Fast Track and Orphan Drug Designations from the FDA for Berubicin.
• An interim analysis planned for mid-2023 to evaluate the treatment's efficacy and safety.

Negative

• None.

Enrollment continuing to progress toward an interim analysis, planned when 30-50% of subjects reach the primary endpoint expected mid-year 2023

HOUSTON, Feb. 7, 2023 /PRNewswire/ -- 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 the first patient in Spain has been enrolled in the Company's 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 has opened 37 clinical trial sites of the 59 sites selected across the U.S., Italy, France, Spain, and Switzerland. A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have reached the primary endpoint. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

"We continue to rapidly build momentum with patient enrollment across our clinical trial sites in Europe. The pace at which we are enrolling patients is encouraging and driving us toward our planned interim analysis, which we expect mid-year 2023. We sincerely appreciate the institutions, clinicians and staff that are contributing to the conduct of this trial, and are extremely grateful to the patients that choose to participate. We are laser focused on executing on clinical development plans and look forward to providing updates," 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 mid-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.

FAQ

What is the significance of CNS Pharmaceuticals enrolling its first patient in Spain for Berubicin?

The enrollment marks a critical step in advancing the global trial for Berubicin, aimed at evaluating its effectiveness against recurrent glioblastoma multiforme.

When is the interim analysis for CNS Pharmaceuticals' trial of Berubicin expected?

The interim analysis is anticipated in mid-2023, after 30-50% of subjects reach the primary endpoint.

How many clinical trial sites has CNS Pharmaceuticals opened for Berubicin?

CNS Pharmaceuticals has opened 37 out of the planned 59 clinical trial sites for Berubicin.

What designations has Berubicin received from the FDA?

Berubicin has received Fast Track and Orphan Drug Designations from the FDA, which can expedite its development and provide marketing exclusivity.