HOUSTON, Jan. 28, 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
that Anthem Biosciences of Bangalore,
India (Anthem) has completed a pilot run of the
recrystallization of the Reata Pharmaceuticals, Inc. API (Reata).
It has also completed a lyophilization of the API. Samples of the
drug product, which include 299 capped vials, have been shipped to
Intertek Pharmaceutical Services (Intertek) for further analysis
and release.
As previously announced, the FDA agreed in a preclinical
submission that CNS could use Reata API as long as it was
reprocessed and released under GMP conditions, and that the new
lyophilized form of the drug product could be used during the
Company's upcoming clinical trial. Anthem, a full-service provider
of GMP manufacturing for APIs, completed this pilot run of the
Reata API. The pilot run recrystallization passed all
specifications at Intertek. The recrystallized API was shipped to
Lyophilization Technology, Inc. a leader of GMP lyophilization
of Drug Products for clinical trials, which completed a pilot
lyophilization. The pilot run of lyophilized API was successfully
tested and released by Intertek. DavosPharma, a Davos Chemical
Company, acted on behalf of the Company as the coordinating
manufacturing broker for all of these processes.
"We are excited to achieve another important milestone in the
development of Berubicin," stated John
Climaco, CEO of CNS Pharmaceuticals. "We look forward to
completing both GMP manufacturing processes and release for
clinical trials."
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 receive
a COA for the GMP reprocessed API, and to achieve the large-scale
production 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.