HOUSTON, Dec. 10, 2019 /PRNewswire/ -- CNS
Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a
biotechnology company specializing in the development of novel
treatments for brain tumors, received positive feedback from the
U.S. Food and Drug Administration (FDA) for its Pre-IND
(Investigational New Drug) meeting proposal to use a lyophilized
drug product, Berubicin, in Phase II clinical trials.
In its positive response to the Company's previously submitted
Pre-IND request, the FDA indicated that the proposal to use a
lyophilized drug product in the Phase II clinical trial appears
reasonable. The FDA recommended that the existing supply of
Berubicin be reprocessed by batch recrystallization. Furthermore,
the FDA noted that the requested dosage regimen, which will be
based on the Reata Phase I trial, was reasonable. The Company plans
to reprocess its existing supply of Berubicin ahead of its upcoming
potential Phase II study.
"We were encouraged by the initial feedback provided by the FDA
as we believe the availability of our existing supply of Berubicin
for a Phase II trial represents significant costs savings and
eliminates excess risk and time," stated CEO of CNS, John M. Climaco. "We are continuing the process
of preparing a new IND in accordance with the guidance we received
from the FDA. 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
offer oncologists the only anthracycline effective 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.