HOUSTON, Oct. 1, 2020 /PRNewswire/ -- CNS
Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"),
a biopharmaceutical company specializing in the development of
novel treatments for primary and metastatic cancers of the brain
and central nervous system, today announced that the Company's GMP
manufacturer partner NCK A/S, received a Certificate of Analysis
(CoA) for its Active Pharma Ingredient (API), clearing it for use
in the production of Berubicin.
As previously announced, CNS signed a contract with NCK A/S for
the large-scale production of Berubicin, its lead drug candidate
for the treatment of glioma brain tumors. NCK A/S is a GMP
manufacturer of complex drugs located in Farum, Denmark, and the previous producer of
Berubicin for Reata Pharmaceuticals. NCK A/S production of
Berubicin should ensure drug availability through the end of Phase
2 clinical trials for glioblastoma.
"We believe the execution of this critical manufacturing
milestone positions the company advantageously ahead of our
expected U.S. Phase 2 trial," stated John
Climaco, CEO of CNS Pharmaceuticals. "Our partnerships have
proven instrumental in further progressing the manufacturing
process necessary to continue the clinical development of our lead
candidate. We look forward to continuing the work underway and to
initiating our U.S. Phase 2 trial in Q1 of 2021."
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is developing novel treatments for primary
and metastatic cancers of the brain and central nervous system. Its
lead drug candidate, Berubicin, is proposed for the treatment of
glioblastoma multiforme (GBM), an aggressive and incurable form of
brain cancer. CNS holds a worldwide exclusive license to the
Berubicin chemical compound and has acquired all data and know-how
from Reata Pharmaceuticals, Inc. related to a completed Phase 1
clinical trial with Berubicin in malignant brain tumors, which
Reata conducted in 2006. In this trial, 44% of patients experienced
a statistically significant improvement in clinical benefit. This
44% disease control rate was based on 11 patients (out of 25
evaluable patients) with stable disease, plus responders. One
patient experienced a durable complete response and remains
cancer-free as of February 20, 2020.
These Phase 1 results represent a limited patient sample size and,
while promising, are not a guarantee that similar results will be
achieved in subsequent trials. By the end of 2020, CNS expects to
commence a Phase 2 clinical trial of Berubicin for the treatment of
GBM in the U.S., while a sub-licensee partner undertakes a Phase 2
trial in adults and a first-ever Phase 1 trial in pediatric GBM
patients in Poland. Its second drug candidate, WP1244, is a
novel DNA binding agent that has shown in preclinical studies that
it is 500 times more potent than the chemotherapeutic agent
daunorubicin in inhibiting tumor cell proliferation.
Forward-Looking Statements
Some of the statements in this press 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
initiate its Phase 2 trial in the fourth quarter of this year.
These statements relate to future events, future expectations,
plans and prospects. Although CNS believes 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 in the Company's SEC
filings, including under the heading "Risk Factors" in the Form S-1
filed on October 7, 2019. Any
forward-looking statements contained in this press release speak
only as of its date. CNS undertakes no obligation to update any
forward-looking statements contained in this press 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.