HOUSTON, Dec. 17, 2019 /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
the completed good manufacturing practice (GMP) reprocessing of its
lead drug candidate, Berubicin, with partner Anthem Biosciences
Pvt. Ltd. of Banglaore, India,
("Anthem") an internationally recognized Contract Research and
Innovation Service Provider specializing in complex medicinal
chemistry.
This critical manufacturing step was undertaken pursuant to
previously announced positive feedback from the U.S. Food and Drug
Administration (FDA) for the Company's Pre-IND (Investigational New
Drug) meeting proposal to use a lyophilized drug product,
Berubicin, in Phase II clinical trials.
In its response to the Company's Pre-IND request, the FDA agreed
that CNS' proposal to use a lyophilized drug product, that was
developed previously but not used clinically, is acceptable. The
FDA further stated that the Company's proposal to utilize its
existing supply of Berubicin in its proposed Phase 2 clinical trial
was reasonable if the Berubicin was reprocessed by batch GMP
recrystallization and released under GMP specifications. In
response to the FDA's guidance, CNS contracted with Anthem and
completed the GMP reprocessing of CNS' existing supply of
Berubicin.
"We are thankful to have such an experienced partner, Anthem,
assist us in completing the critical reprocessing work of our
existing Berubicin supply," stated CEO of CNS, John M. Climaco. "The GMP reprocessing was a
significant milestone in our continued efforts to prepare a new IND
in accordance with the FDA guidance we received. We look forward to
our upcoming potential Phase II trial evaluating the efficacy of
Berubicin in subjects who have glioblastoma that has recurred or
progressed following radiation therapy and temozolomide, as we
believe in Berubicin's potential to demonstrate in clinical trials
that it can become the only effective anthracycline against brain
cancer."
About Berubicin
Berubicin is an anthracycline, a class
of drugs among the most powerful chemotherapy drugs and effective
against more types of cancer than any other class of
chemotherapeutic agents. Anthracyclines are designed to damage the
DNA of targeted cancer cells by interfering with the action of the
topoisomerase II, a critical enzyme enabling cell proliferation.
Berubicin was developed at the MD Anderson Cancer Center (MDACC),
the world's largest cancer research facility. Berubicin appeared to
demonstrate one Durable Complete Response in a Phase I human
clinical trial conducted by a prior developer.
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 for the treatment of
glioblastoma, a type of brain cancer currently considered
incurable, as well as pancreatic and ovarian cancers, and
lymphomas. The Company entered into an IP agreement with Houston
Pharmaceuticals, Inc. and a Purchase Agreement with Reata
Pharmaceuticals, Inc. 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 prepare
its IND and to reprocess its existing supply of Berubicin ahead of
its upcoming potential Phase II study. 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.