CNS Pharmaceuticals (NASDAQ: CNSP) Presents Updated Results from On-Going Potentially Pivotal Study of Berubicin in Adult Patients with Recurrent GBM (WHO Grade IV) After Failure of Standard First Line Therapy

Rhea-AI Summary

CNS Pharmaceuticals presented updated results from the ongoing study evaluating Berubicin for the treatment of Glioblastoma Multiforme (GBM) at the 2023 SNO/ASCO CNS Cancer Conference. The study has enrolled 151 patients, with 105 on Berubicin and 46 on Lomustine. Preliminary results show that Berubicin is safe and well tolerated. The primary endpoint of the study is Overall Survival (OS), and the company is conducting a futility analysis to determine whether to continue the study as planned.

Positive

• Berubicin has demonstrated its capability to be an innovative treatment in GBM that is safe and well tolerated
• Enrolled patients received 7.5 mg/m2/day of intravenous (IV) Berubicin over 2 hours for 3 consecutive days every 21 days
• Approximately 50% of patients on both arms have completed the study
• Primary reasons for withdrawal include Adverse Events, Physician Decision, Withdrawal by Patient, and Death
• All grades of adverse events occurring in more than 10% of patients are similar in the Berubicin and Lomustine arms
• The primary endpoint of the study is Overall Survival (OS)
• CNS Pharmaceuticals has reached the criteria required to conduct a non-binding futility analysis
• The company is confident it will announce the results from the interim analysis before the year end
• Enrollment will continue during the interim analysis

Negative

• None.

Data presented at the 2023 SNO/ASCO CNS Cancer Conference

Berubicin currently being evaluated in an ongoing potentially pivotal study for the treatment of Glioblastoma Multiforme (GBM) with topline data from interim analysis expected before year end

HOUSTON, TX / ACCESSWIRE / August 14, 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 presentation of updated results from the on-going potentially pivotal study evaluating Berubicin, the Company's novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier, in a poster presentation at the 2023 SNO/ASCO CNS Cancer Conference, held August 10-12, 2023 in San Francisco, CA.

The poster, titled, "A randomized, controlled trial of Berubicin, a topoisomerase II poison that appears to cross the blood-brain barrier (BBB), after first-line therapy for glioblastoma multiforme (GBM): Preliminary Results," was presented by Sandra Silberman, MD, PhD, Chief Medical Officer of CNS Pharmaceuticals. The presented poster is now available on the Company's website.

"Berubicin has demonstrated its capability to be an innovative treatment in GBM that is safe and well tolerated, which has the potential to be a novel and effective therapy for this disease. Based on the results we've seen preclinically and in the clinic thus far, including these updated results from our on-going potentially pivotal study, we remain optimistic that Berubicin may provide a much needed clinical benefit for GBM patients. We look forward to upcoming interim results that will evaluate Berubicin compared to the current standard of care (Lomustine) for second line therapy in this disease," commented Dr. Silberman.

As of the data cutoff for the poster, 151 patients had been enrolled, 105 on Berubicin and 46 on Lomustine. Enrolled patients received 7.5 mg/m²/day of intravenous (IV) Berubicin over 2 hours for 3 consecutive days (one cycle) every 21 days.

Previous results from this study were presented in November 2022 at the Society for Neuro-Oncology (SNO) 27^th Annual Meeting.

Summary of Updated Results from the Potentially Pivotal Study:

• All patients enrolled show comparable demographics for each arm, including age, gender, race, BSA, and KPS. In addition, patients have been stratified by MGMT methylation, allowing a reasonable comparison of efficacy based on this prognostic feature between the two groups. The unmethylated MGMT population comprises approximately 38% of all enrolled patients.
• Approximately 50% of patients on both arms have completed the study, i.e. have participated in an end of treatment (EOT) visit, and withdrawal prior to EOT is relatively small, although almost twice the percent of patients in the Lomustine group compared to Berubicin have withdrawn. Primary reasons for withdrawal across both arms include Adverse Events, Physician Decision, Withdrawal by Patient, and Death as well as Other nonspecified reasons.
• All grades of adverse events occurring in more than 10% of patients, as well as Grade 3-5 events, are presented in the poster, with the overall percentages similar in the Berubicin and Lomustine arms. In terms of myelosuppression (complete blood counts), neutrophil, and red blood cell count [anemia] reductions are also similar however thrombocytopenia seems to be higher in the Lomustine arm.

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.

CNS Pharmaceuticals recently announced it has now reached the criteria required by the study protocol to conduct a pre-planned, non-binding futility analysis, which an independent Data Safety Monitoring Board (DSMB) will review to determine whether to recommend continuing the study as planned or modifying the study based on Berubicin showing potential value as a second-line treatment for patients with glioblastoma. CNS Pharmaceuticals previously reported that the Company would 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) had reached the primary efficacy endpoint, as provided for in the study protocol. The DSMB will review the number of deaths in 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 will include comparisons of secondary endpoints, including progression-free survival (PFS), response rates, and safety assessments. The Company is confident it will announce the results from the interim analysis publicly before the year end. Enrollment will continue during the interim analysis.

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, 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 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 interim analysis to occur before year end, the ability to continue to open additional clinical trial sites on a timely basis, and whether the FDA will recognize the Company's primary endpoint as a basis for approval. 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 purpose of the study presented by CNS Pharmaceuticals?

The purpose of the study is to evaluate the effectiveness of Berubicin for the treatment of Glioblastoma Multiforme (GBM).

How many patients have been enrolled in the study?

The study has enrolled 151 patients, with 105 on Berubicin and 46 on Lomustine.

What is the primary endpoint of the study?

The primary endpoint of the study is Overall Survival (OS).

What is a futility analysis?

A futility analysis is conducted to determine whether a study should be continued as planned based on the potential value of the treatment being evaluated.

When will the results from the interim analysis be announced?

The company is confident it will announce the results from the interim analysis before the year end.