CNS Pharmaceuticals Announces Dosing of First Patient in Europe/France in Ongoing Potentially Pivotal Global Trial Evaluating Berubicin for the Treatment of GBM

Rhea-AI Summary

CNS Pharmaceuticals has initiated dosing for its first patient in France as part of a global trial for Berubicin, targeting recurrent glioblastoma multiforme (GBM).

The ongoing study aims to evaluate the drug's safety and efficacy, with a planned interim analysis after 30-50% of participants complete six months in the trial. A total of 68 trial sites across the U.S. and Europe have been established.

Berubicin, the first anthracycline to cross the blood-brain barrier, has received Fast Track and Orphan Drug Designation from the FDA.

Positive

• First patient dosed in France, expanding the trial's geographic reach.
• 29 out of 68 planned clinical trial sites opened.
• Fast Track and Orphan Drug Designation from the FDA for Berubicin.
• Potential for significant improvement in overall survival as a primary endpoint.

Negative

• None.

Enrollment progressing toward interim analysis, planned when 30-50% of subjects reach 6 months in study

HOUSTON, Nov. 2, 2022 /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 the first patient in Europe has been enrolled and dosed in France 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 29 clinical trial sites of the 68 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 completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

"Our team has worked tirelessly to expand the presence of our clinical trial for Berubicin on a global scale. To have enrolled and dosed our first patient in France shortly after the opening the site is a noteworthy accomplishment and a testament to our team's dedication to drive the program forward. I am pleased with the progress made and remain committed to building on this momentum. We expect to enroll and dose additional patients across our clinical trial sites in Europe and advance toward the much-anticipated inflection point which is the interim analysis," 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. The potentially pivotal trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV1) after failure of standard first-line therapy. The primary endpoint of the study is Overall Survival (OS), which is a rigorous endpoint that the FDA has recognized as a 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 a current standard of care (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 the potentially pivotal Berubicin 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 also 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.

Additionally, the Company is advancing the development of its WP1244 drug technology portfolio, which utilizes anthracycline and distamycin-based scaffolds to create small molecule agents and is believed to be 500x more potent than daunorubicin in inhibiting tumor cell proliferation. Preclinical studies of WP1244 demonstrated high uptake in the brain with antitumor activity. CNS Pharmaceuticals is evaluating the use of WP1244 in the treatment of brain cancers, pancreatic, ovarian, and lymphomas.

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 ability to enroll and dose additional patients across clinical trial sites in Europe 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 recent development has CNS Pharmaceuticals announced regarding Berubicin?

CNS Pharmaceuticals has announced the dosing of its first patient in France as part of a global trial for Berubicin, aimed at treating recurrent glioblastoma multiforme.

What is the primary endpoint of the Berubicin trial?

The primary endpoint of the Berubicin trial is Overall Survival (OS), which is a critical measure recognized by the FDA for oncology drug approval.

How many clinical trial sites are currently open for the Berubicin study?

Currently, 29 out of the planned 68 clinical trial sites are open across the U.S. and Europe.

What designations has Berubicin received from the FDA?

Berubicin has received both Fast Track Designation and Orphan Drug Designation from the FDA.

When will the interim analysis for the Berubicin trial take place?

The interim analysis is planned when 30-50% of subjects have completed six months in the study.