CNS Pharmaceuticals Inc. Featured in Syndicated Broadcast Covering Dosing of First Patients in Its Berubicin Clinical Development Program for Glioblastoma Multiforme

Rhea-AI Summary

CNS Pharmaceuticals Inc. (NASDAQ: CNSP) announced its Berubicin clinical trial's progress by dosing its first patients for recurrent glioblastoma multiforme (GBM), a severe brain cancer. The pivotal trial, involving 243 patients, aims to evaluate Berubicin’s efficacy against lomustine, focusing on Overall Survival as the primary endpoint. Previous Phase 1 results indicated a 44% clinical benefit rate, with safety consistent with other anthracyclines. CEO John Climaco expressed optimism regarding the trial’s potential and the drug's profile, which appears to cross the blood-brain barrier.

Positive

• Dosed first patients in pivotal Berubicin trial for recurrent glioblastoma multiforme (GBM).
• Previous Phase 1 trial showed 44% clinical benefit, indicating strong potential for GBM treatment.
• Berubicin is the first anthracycline shown to cross the blood-brain barrier, enhancing its treatment efficacy.

Negative

• None.

LOS ANGELES, Oct. 11, 2021 (GLOBE NEWSWIRE) -- via InvestorWire -- CNS Pharmaceuticals Inc. (NASDAQ: CNSP), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announces that it has been featured in a broadcast via NetworkNewsAudio (“NNA”), a solution that delivers additional visibility, recognition and brand awareness in the investment community via distribution to thousands of syndication points. The audio press release covers CNS Pharmaceuticals’ recent announcement of dosing of the first patients in its Berubicin clinical development program for the treatment of recurrent glioblastoma multiforme (GBM), one of the most aggressive types of brain cancer.

To hear the audio production, visit: https://www.nnw.fm/imIah

To read the original press release, visit: https://nnw.fm/QlM2S

“I am extremely pleased with the progress made to-date in this potentially pivotal trial. Our team has been working intensely to open sites in the U.S. and in Europe, understanding where we can best advance this important study,” John Climaco, CEO of CNS Pharmaceuticals, stated in the news release. “With hundreds of potentially competing GBM trials currently enrolling patients, the fact that we've been able to bring these initial sites on-line and get patients enrolled and dosed not only supports our strategic evaluation and selection, but also allows our data demonstrating Berubicin's potential effectiveness to continue to convince the medical community that we have a new drug with impressive potential. With the de-risked profile of Berubicin, its mechanism of action, history of development, encouraging Phase 1 data, and safety in study design, I am personally more optimistic about our work than at any time since joining the company.”

Berubicin is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier currently being evaluated in a global potentially pivotal study evaluating its efficacy and safety. The potentially pivotal trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy. Approximately 243 patients with GBM after failure of standard first line therapy will be randomized in a 2:1 ratio to receive Berubicin or lomustine for the evaluation of Overall Survival, the primary endpoint of the study. Overall Survival is a rigorous endpoint that the U.S. Food and Drug Administration (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.

In the Phase 1 clinical trial previously conducted evaluating Berubicin in patients with previously treated disease, 44% of the patients showed clinical benefit (49% of the Avastin-naïve patient population), with the demonstration that it was effective based on this patient population with a dismal median survival rate of only 14.6 months from diagnosis. One patient in the Phase 1 study had a durable Complete Response (CR, a demonstrated lack of detectable cancer cells) that has continued for 14 years, and another patient had a durable partial response, with others showing substantial stabilization of disease. Additionally, the novel anthracycline agent Berubicin appears to have a toxicity profile consistent with that of other anthracyclines and demonstrates activity as monotherapy for recurrent glioblastoma multiforme. Berubicin has side effects that are able to be effectively treated and managed.

For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

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, 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.

About NetworkNewsAudio

NetworkNewsAudio (“NNA”), one of 50+ brands within IBN (InvestorBrandNetwork), allows you to sit back and listen to market updates, CEO interviews and AudioPressRelease (“APR”) productions. These audio clips provide snapshots of position, opportunity and momentum. NNA can assist by cutting through the overload of information in today's market, while bringing its clients unparalleled visibility, recognition and brand awareness. IBN is where news, content and information converge. IBN is a comprehensive provider of news aggregation and syndication, enhanced press release services and a full array of social communication solutions. As a multifaceted financial news and distribution company with an extensive team of journalists and writers, IBN has the unparalleled ability to reach a wide audience of investors, consumers, journalists and the general public with an ever-growing distribution network of 5,000+ key syndication outlets across the nation.

For more information, visit: www.NetworkNewsAudio.com

Please see full terms of use and disclaimers on the IBN website, applicable to all content provided by IBN wherever published or re-published: https://IBN.fm/Disclaimer

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 ability of the Company's cash runway to extend until Q2 2022 and the timing of patient dosing to commence. 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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FAQ

What is the purpose of CNS Pharmaceuticals' Berubicin clinical trial for CNSP?

The trial aims to evaluate Berubicin's efficacy and safety in treating recurrent glioblastoma multiforme (GBM) in comparison to lomustine.

What were the Phase 1 trial results for Berubicin?

Phase 1 trial results showed a 44% clinical benefit rate, indicating promising efficacy for patients with recurrent GBM.

How many patients are involved in the Berubicin pivotal trial?

The pivotal trial will randomize approximately 243 patients with recurrent GBM.

What is the primary endpoint of the Berubicin study?

The primary endpoint of the study is Overall Survival, which is critical for FDA drug approval.

What is the significance of Berubicin crossing the blood-brain barrier?

Crossing the blood-brain barrier may allow Berubicin to effectively treat brain cancers, which is a significant challenge in cancer therapy.