HOUSTON, Oct. 20, 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 U.S.
manufacturer, Pharmaceutics International, Inc. ("Pii"), has
completed the manufacturing process for Berubicin Drug Product, its
lead drug candidate for the treatment of glioblastoma multiforme
(GBM), an aggressive form of brain cancer currently considered
incurable.
"Completing the manufacturing process for Berubicin in
the United States is an essential
step in our preparations to file an IND during the fourth quarter
of this year," stated John Climaco,
CEO of CNS Pharmaceuticals. "We are extremely pleased to achieve
yet another milestone in our preparation efforts and demonstrate
our continued ability to execute upon both our operational and
clinical strategies in a timely and proficient manner. We remain
committed to further progressing our trial preparations, as we look
forward to initiating a U.S. Phase 2 trial for Berubicin during the
first quarter of 2021."
The Company implemented a dual-track drug product manufacturing
strategy to mitigate COVID-19-related delay risks, diversify its
supply chain and provide for localized availability of Berubicin.
Under this strategy, it engaged two separate manufacturers for
Berubicin on different continents. In the
United States, the Company engaged Pii, who has now
completed manufacturing, and in Italy it engaged BSP Pharmaceuticals S.p.A.
("BSP"). BSP has begun the manufacturing process, which is expected
to be completed early in the fourth quarter this year.
In addition to its manufacturing efforts, the Company has also
made progress in its clinical trial preparations. CNS recently
engaged Worldwide Clinical Trials as the contract research
organization, Image Analysis Group ("IAG") as the imaging partner,
and Berry Consultants as a biostatistical advisor for its Phase 2
trial design. The Company has also added Dr. Patrick Wen, a renowned neuro-oncologist, to its
Scientific Advisory Board. The FDA granted the Company Orphan Drug
Designation (ODD) for Berubicin for the treatment of malignant
gliomas, which include GBM. The designation provides Berubicin with
certain benefits during the product's development to treat
malignant gliomas and provides CNS with the potential for market
exclusivity upon the drug's approval for that use.
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 file an
IND in the fourth quarter of this year and to initiate its Phase 2
trial for Berubicin in the first quarter of 2021. 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
under Item 1A. "Risk Factors" in CNS's most recently filed Form
10-K filed with the Securities and Exchange Commission ("SEC") and
updated from time to time in its Form 10-Q filings and in its other
public filings with the SEC.. 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.