HOUSTON, Dec. 2, 2021 /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 in the brain
and central nervous system, today announced it has received
approval from swissethics, the umbrella organization of the
cantonal Ethics Committees (EC) in Switzerland, for the Company's potentially
pivotal study of Berubicin for the treatment of recurrent
glioblastoma multiforme (GBM), one of the most aggressive types of
Berubicin is a novel anthracycline and the first anthracycline
to appear to cross the blood-brain barrier currently being
evaluated in a potentially pivotal global study evaluating its
efficacy and safety in the treatment of GBM.
"Receiving approval from swissethics is a significant milestone
for the Company. Our stated goal is, and always has been, to see
Berubicin approved for the treatment of glioblastoma, and this
means globally. This terrible disease does not discriminate on the
basis of geography or anything else: Patients in Europe are as desperate as patients in
the United States, and treating
patients is not only why we do what we do, but how we do it as
well. Driving patient enrollment is how we advance Berubicin's
development and opening additional clinical sites around the globe
is the pivotal piece that allows us to ramp up our efforts and move
toward data. We are deeply grateful that Switzerland has the first European EC to
approve our Berubicin trial, but we are confident it will be far
from the last in this truly global effort. We have a number of
additional clinical sites selected around the world that we
anticipate coming online in the very near term. As we progress, my
belief grows in the enormous potential of Berubicin to be a
critical treatment option for this devastating disease. I am
proud of the accomplishments we've made with this potentially
pivotal trial to-date, but we will not pause for a single second
until Berubicin reaches its full potential to offer hope to GBM
patients everywhere," commented John
Climaco, CEO of CNS Pharmaceuticals.
The potentially pivotal global trial is an adaptive,
multicenter, open-label, randomized and controlled study in adult
patients with recurrent glioblastoma multiforme (WHO Grade IV)
after failure of standard first-line therapy. Approximately 243
patients with GBM after failure of standard first line therapy will
be randomized in a 2:1 ratio to receive Berubicin or lomustine for
the evaluation of Overall Survival, the primary endpoint of the
study. Overall Survival is a rigorous endpoint that the U.S. Food
and Drug Administration (FDA) has recognized as a basis for
approval of oncology drugs when a statistically significant
improvement can be shown relative to a randomized control arm.
A pre-planned, non-binding futility analysis will be performed
after approximately 30 to 50% of all planned patients have
completed the primary endpoint at 6 months. This review will
include additional evaluation of safety as well as secondary
efficacy endpoints. Enrollment will not be paused during this
The FDA recently granted CNS Pharmaceuticals Fast Track
Designation for Berubicin which enables more frequent interactions
with the FDA to expedite the development and review process. As
previously announced, the Company also received Orphan Drug
Designation from the FDA which may provide seven years of marketing
exclusivity upon approval of an NDA.
For more information about the potentially pivotal Berubicin
trial, visit clinicaltrials.gov and reference identifier
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
Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal
Chemistry at The University of Texas MD
Anderson Cancer Center.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals a clinical-stage pharmaceutical company
developing a pipeline of anti-cancer drug candidates for the
treatment of primary and metastatic cancers of the brain and
central nervous system. The Company's lead drug candidate,
Berubicin, is a novel anthracycline and the first anthracycline to
appear to cross the blood-brain barrier. Berubicin is currently in
development for the treatment of a number of serious brain and CNS
oncology indications including glioblastoma multiforme (GBM), an
aggressive and incurable form of brain cancer.
Additionally, the Company is advancing the development of its
WP1244 drug technology, which utilizes anthracycline and
distamycin-based scaffolds to create small molecule agents and is
believed to be 500x more potent than daunorubicin in inhibiting
tumor cell proliferation. Preclinical studies of WP1244
demonstrated high uptake in the brain with antitumor activity. CNS
Pharmaceuticals is evaluating the use of WP1244 in the treatment of
brain cancers, pancreatic, ovarian, and lymphomas.
For more information, please visit www.CNSPharma.com, and
connect with the Company on Twitter, Facebook, and LinkedIn.
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's
cash runway to extend until Q2 2022 and the timing of patient
dosing to commence. 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.