CNS Pharmaceuticals Continues Momentum in Ongoing Potentially Pivotal Global Trial Evaluating Berubicin for the Treatment of GBM with First Patient Enrolled in Switzerland

Rhea-AI Summary

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) announced the enrollment of the first patient in Switzerland for its global trial evaluating Berubicin in treating recurrent glioblastoma multiforme (GBM). The trial has opened 40 of 59 planned sites in the U.S., Italy, France, Spain, and Switzerland, with an interim analysis expected mid-2023 when 30-50% of subjects reach primary endpoints. Berubicin, an anthracycline that crosses the blood-brain barrier, aims to address the significant unmet need in GBM treatment. The FDA has granted Fast Track and Orphan Drug designations to Berubicin, facilitating expedited development and potential marketing exclusivity.

Positive

• Enrollment of the first patient in Switzerland signals progress in the ongoing pivotal trial for Berubicin.
• 40 out of 59 planned clinical trial sites are now operational across multiple countries.
• FDA Fast Track and Orphan Drug designations may expedite the drug's development and offer marketing exclusivity.

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, March 9, 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 Switzerland 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 40 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.

"The active patient enrollment we continue to build across our clinical trial sites in Europe is incredibly encouraging. Our team is laser focused on getting additional clinical trial sites online so that we can continue to advance toward our planned interim analysis, which we expect mid-year 2023. We are continually grateful to 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. There remains a significant unmet need in the treatment of GBM and we remain committed to advancing Berubicin to potentially offer a much-needed therapy for this devastating cancer," commented John Climaco, CEO of CNS Pharmaceuticals.

Professor Michael Weller, MD, University Hospital Zurich and National Coordinating Investigator for the potentially pivotal study, added, "I believe Berubicin has the potential to play an important role in the treatment of this devastating disease. We are committed to working alongside the CNS Pharmaceuticals team to advance the development of Berubicin and are pleased to commence patient enrollment at our site(s) in Switzerland."

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 the first patient enrolled in Switzerland for CNS Pharmaceuticals?

The first patient's enrollment in Switzerland marks a crucial step forward in CNS Pharmaceuticals' global trial for Berubicin, targeting recurrent glioblastoma multiforme.

What is Berubicin being evaluated for by CNS Pharmaceuticals?

Berubicin is being evaluated for its efficacy and safety in treating recurrent glioblastoma multiforme (GBM), an aggressive brain cancer.

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

CNS Pharmaceuticals has opened 40 of the 59 planned clinical trial sites for the Berubicin trial across multiple countries.

What designations has the FDA granted to Berubicin?

The FDA has granted Fast Track and Orphan Drug designations to Berubicin, facilitating its development and potential marketing exclusivity upon approval.

When is the interim analysis for the Berubicin trial expected?

The interim analysis for the Berubicin trial is expected to occur in mid-2023 when 30-50% of subjects complete the primary endpoint.