HOUSTON, 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."
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.
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.
Forward-Looking Statements
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.