Home Medicinal chemistry CNS Pharmaceuticals receives an A – GuruFocus.com

CNS Pharmaceuticals receives an A – GuruFocus.com

0

Expanded eligibility for patients who have received multiple therapies as first-line therapy for GBM

The company continues to recruit patients for the trial with 19 clinical trial sites open to date and 42 additional sites selected across the United States, Italy, France, Spainand Swiss who will be initiated and register soon

Interim analysis of the trial when 30 to 50% of subjects reach 6 months of study

HOUSTON, June 23, 2022 /PRNewswire/ — CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biopharmaceutical company focused on developing novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that it has received Food and Drug United States Administration (FDA) for its potentially pivotal ongoing global study evaluating the efficacy and safety of Berubicin compared to Lomustine (Gleostine) given after first-line therapy for the treatment of recurrent glioblastoma multiforme (GBM), one of the most aggressive types of brain cancer.

“We are delighted to have received this positive response from the FDA and to continue to advance the clinical development program for berubicin. The primary goals of the protocol amendment are based on feedback we received from investigators and on a more in-depth consideration of the needs of patients on the We have also incorporated the recent WHO classification of glioblastoma1 with relevant guidelines, ensuring that these patients meet specific criteria that allow us to precisely position the program for success. I am proud of the progress we continue to make on the clinical and regulatory fronts and look forward to moving this important trial forward,” commented John ClimacoCEO of CNS Pharmaceuticals.

Berubicin is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier currently being evaluated in a potentially pivotal global study evaluating its efficacy and safety.

The potentially pivotal 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 treatment. The primary endpoint of the study is overall survival (OS), which is a stringent endpoint that the FDA has recognized as the basis for approving oncology drugs when a statistically significant improvement can be demonstrated by compared to a randomized control group. The trial results will compare berubicin to a current standard of care (lomustine), with patients randomized 2 to 1 to receive either berubicin or lomustine. The amended protocol extends study eligibility to patients who have received additional treatments as part of the first-line treatment of their disease in light of advances in this area. This change was made due to the complexity of new agents being introduced as a component of first-line treatment, which allows for an additional group of patients to enroll in the study after what may amount to several procedures as initial treatment. .

A pre-planned, non-binding futility analysis will be performed after 30-50% of all planned patients have completed 6 months of treatment. This evaluation will include safety as well as secondary efficacy endpoints. Registration will not be interrupted during this interim analysis.

“The operational objectives of this study remain our priority, including the use of patient-reported outcomes, stratification based on MGMT methylation status (a prognostic factor in glioblastomas), and the provision of both drug to the study, berubicin, as well as the comparator drug, lomustine, for all sites. With recent regulatory approvals received in Europewe are currently in the process of opening clinical sites around the world, including France, Italy, Spainand Swiss, to expand the scope and reach of patients for this trial. We remain committed to advancing this study and ultimately hope to provide a much-needed option for the treatment of GBM as a safe and effective therapy,” added Sandra L. SilbermanMD, Ph.D. Medical Director of CNS Pharmaceuticals.

The FDA has granted CNS Pharmaceuticals Fast Track Designation for Berubicin, which allows for 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 can provide seven years of market exclusivity upon approval of an NDA.

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

About Berubicin

Berubicin is an anthracycline, a class of anticancer drugs that are among the most potent and effective chemotherapy drugs against more types of cancer than any other class of chemotherapy drugs. Anthracyclines are designed to use natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, an essential enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include a durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin was developed by Dr. Waldemar Priebeprofessor of medicinal chemistry at University of Texas MD Anderson Cancer Center.

About CNS Pharmaceuticals, Inc.

CNS Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of 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 uses anthracycline and distamycin-based scaffolds to create small molecule agents and is said to be 500 times more potent than daunorubicin in inhibiting proliferation. tumor cells. Preclinical studies of WP1244 demonstrated strong brain uptake with antitumor activity. CNS Pharmaceuticals is evaluating the use of WP1244 in the treatment of brain, pancreatic, ovarian and lymphoma cancers.

For more information, please visit www.CNSPharma.comand connect with the Company on Twitter, Facebookand LinkedIn.

Forward-looking statements

Certain 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, but are not limited to, the timing of the opening of new sites in Europe. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that the expectations reflected in these forward-looking statements are reasonable as of the date they are made, the expectations may turn out to be materially different from the results expressed or implied by these forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ”believes” ”estimates” ”anticipates” ”expects” ”plans” ”projects” ”a l ‘intent,’ ”potential”, ”may” ”could” ”could” ”will” ”should” ”approximately” or other words that convey uncertainty future events or results to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed in 1A. “Risk Factors” in CNS’s most recent Form 10-K filings with the Securities and Exchange Commission (“SEC”) and as updated from time to time in its Form 10-Q filings and other public filings with the SEC. All 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 unforeseen events.


1 Editorial Board of the WHO Classification of Tumours. World Health Organization classification of tumors of the central nervous system. 5th ed. Lyons: International Agency for Research on Cancer; 2021

favicon.png?sn=DA97639&sd=2022-06-23 Show original content to download multimedia:https://www.prnewswire.com/news-releases/cns-pharmaceuticals-receives-approval-from-us-fda-for-protocol-amendment-to-ongoing-potentially-pivotal-global-trial-evaluating-berubicin- for-processing-gbm-301573601.html

SOURCESNC Pharmaceuticals, Inc.