CNS Pharmaceuticals Announces Adaptive Trial Design For Berubicin Phase 2 Clinical Trial To Be Submitted for FDA Review

Rhea-AI Summary

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) announces a video update on November 12, 2020, discussing its Phase 2 trial for Berubicin, aimed at treating glioblastoma multiforme. This trial will randomize patients to receive either Berubicin or standard care, incorporating interim assessments for safety and effectiveness. CNS plans to submit an FDA Investigational New Drug application based on encouraging Phase 1 results, where a 44% disease control rate was observed. The company holds exclusive rights to Berubicin and is advancing its clinical trials for both adult and pediatric patients.

Positive

• Plan to submit FDA Investigational New Drug application for Berubicin.
• Upcoming Phase 2 trial designed to evaluate safety and effectiveness against standard care.
• Phase 1 results showed a 44% disease control rate, indicating potential efficacy.

Negative

• None.

HOUSTON, Nov. 9, 2020 /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 of the brain and central nervous system, today announced it will be issuing a video update on November 12^th, 2020 at 4:30pm ET to discuss the clinical trial design for its upcoming Phase 2 U.S. trial for Berubicin, its lead drug candidate for the treatment of glioblastoma multiforme (GBM), an aggressive form of brain cancer, currently considered incurable. The discussion will be moderated by Robert LeBoyer, Managing Director of Equity Research at Ladenburg Thalmann & Co., Inc.

The Company plans to submit an Investigational New Drug (IND) application to the U.S. Food & Drug Administration (FDA), which includes a novel clinical trial designed to build on the encouraging results observed in a prior Phase 1. The Phase 2 trial will randomize patients to Berubicin or standard of care. This upcoming trial will include interim assessments that will evaluate the comparative safety and effectiveness of these treatments with an adaptive design intended to complete a thorough investigation into Berubicin as expeditiously as possible.

Details of the webinar are below:
Date: November 12^th, 2020
Time: 4:30 PM ET
Link: https://cnspharma.com/webcast-november-2020/

About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006. In this trial the overall response rate of stable disease or better was 44%. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland. Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation.

For more information, please visit www.CNSPharma.com.

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 to seek accelerated approval from the FDA of a New Drug Application (NDA) following the planned Berubicin trial. 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
James Salierno
The Ruth Group
646-536-7028
jsalierno@theruthgroup.com 

Media Contact
Kirsten Thomas
The Ruth Group
(508) 280-6592
kthomas@theruthgroup.com

Corporate Communications:
InvestorBrandNetwork (IBN)
Los Angeles, California
www.InvestorBrandNetwork.com
310.299.1717 Office
Editor@InvestorBrandNetwork.com

View original content to download multimedia:http://www.prnewswire.com/news-releases/cns-pharmaceuticals-announces-adaptive-trial-design-for-berubicin-phase-2-clinical-trial-to-be-submitted-for-fda-review-301168491.html

SOURCE CNS Pharmaceuticals, Inc.

FAQ

What is the purpose of CNS Pharmaceuticals' upcoming Phase 2 trial for Berubicin?

The Phase 2 trial aims to evaluate Berubicin's safety and effectiveness compared to standard care for glioblastoma multiforme.

When will CNS Pharmaceuticals provide an update on Berubicin's Phase 2 trial?

CNS Pharmaceuticals will issue a video update on November 12, 2020, at 4:30 PM ET.

What were the results of the Phase 1 trial for Berubicin?

The Phase 1 trial showed a 44% disease control rate among evaluable patients, with one patient remaining cancer-free.

What is CNS Pharmaceuticals' next step after the Phase 2 trial?

CNS plans to seek FDA accelerated approval based on the trial results for a New Drug Application.