, Feb. 4, 2020
/PRNewswire/ -- CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, today announced it has completed the final GMP manufacturing run of its lead candidate Berubicin, which it acquired from Reata Pharmaceuticals, Inc. (Reata), and that the GMP material has met all specifications.
Samples of the lyophilized drug product were shipped to Intertek Pharmaceutical Services (Intertek), for final GMP testing. The pilot recrystallization run met all specifications and the initial GMP run passed all specifications; however, it was discovered that one of the standard 10 metals in Heavy Metals Test, bismuth, was not officially validated for that assay. This did not prevent the formulation of the final drug product. Subsequently, heavy metals including bismuth were again tested and met all specifications. Additionally, the Company is continuing large scale production of Berubicin through NCK A/S. The Company intends to utilize this supply of Berubicin for its potential upcoming Phase II clinical trial in Glioblastoma.
"Completing GMP Manufacturing represents another pivotal step in our Berubicin production," stated John Climaco
, CEO of CNS Pharmaceuticals. "We are excited to continue our productive start to 2020 by completing another manufacturing milestone and look forward to further advancing both the production and clinical development of our lead candidate. We hope to continue our manufacturing success and utilize our supply of Berubicin for upcoming clinical trials and commercial use."
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.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is a biotechnology company specializing in the development of novel treatments for primary and metastatic brain and central nervous system tumors. Its lead candidate Berubicin is proposed for the treatment of glioblastoma, a type of brain cancer currently considered incurable, as well as for pancreatic and ovarian cancers, and lymphomas. The Company entered into an intellectual property (IP) agreement with Houston Pharmaceuticals, Inc. and a Purchase Agreement with Reata. For more information, visit www.cnspharma.com.
Some of the statements in this 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 further the clinical development of Berubicin. These statements relate to future events, future expectations, plans and prospects. Although CNS believes that 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 in our SEC filings, including under the heading "Risk Factors" in the Form S-1 we filed with the SEC on October 7, 2019
. Any forward-looking statements contained in this release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this 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.