Sites in France and Spain now open and actively enrolling
Enrollment progressing with 26 clinical trial
sites open to-date of the 59 sites
selected across the U.S., Italy,
France, Spain, and Switzerland
Interim analysis of the trial when 30-50% of
subjects reach 6 months in study
HOUSTON, Sept. 28,
2022 /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 the activation of its first
clinical trial sites in Europe for
the ongoing potentially pivotal global trial evaluating Berubicin
for the treatment of recurrent glioblastoma multiforme (GBM), one
of the most aggressive types of brain cancer. These first European
clinical trial sites in France and
Spain are now open and actively
enrolling patients.
![(PRNewsfoto/CNS Pharmaceuticals, Inc.) (PRNewsfoto/CNS Pharmaceuticals, Inc.)](https://mma.prnewswire.com/media/1120277/CNS_Pharmaceuticals_Logo.jpg)
"Our primary focus continues to be on advancing the clinical
development of Berubicin as a potential treatment option for this
devastating disease. Over the course of this year, we have worked
diligently to expand patient eligibility for our potentially
pivotal trial and bolster our international presence now realized
with the activation of the first two European clinical trial sites.
This is a true testament to our team's commitment to and the
execution of this important clinical program. We are grateful for
the tremendous support from the clinical staff and remain dedicated
to driving patient enrollment as quickly and efficiently as
possible. We look forward to continuing to build momentum and
bringing Berubicin across the finish line to unlock its greatest
potential. As long as the unmet medical need in GBM remains, we
will continue our fight in earnest to bring hope to patients and
families globally," commented John
Climaco, CEO of CNS Pharmaceuticals.
Berubicin, is a novel anthracycline and the first anthracycline
to appear to cross the blood-brain barrier. Berubicin is currently
being evaluated in a potentially pivotal global study evaluating
its efficacy and safety in the treatment of GBM. The potentially
pivotal trial is an adaptive, multicenter, open-label, randomized
and controlled study in adult patients with recurrent glioblastoma
multiforme (WHO Grade IV1) after failure of standard first-line
therapy. The primary endpoint of the study is Overall Survival
(OS), which is a rigorous endpoint that the 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. Results from the trial will compare Berubicin to a
current standard of care (Lomustine), with a 2 to 1 randomization
of patients to receive either Berubicin or Lomustine. The recently
amended protocol expands eligibility for the study to patients who
have received additional treatments as part of the first line
therapy for their disease considering advancements in this area.
This change was made due to the complexity of new agents introduced
as a component of first line therapy, which allows an additional
group of patients that can enroll on the study after what may
constitute multiple procedures as their initial treatment.
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
interim analysis.
The FDA has granted CNS Pharmaceuticals Fast Track Designation
for Berubicin which enables more frequent interactions with them to
provide guidance on expediting the development and review process.
Additionally, the Company has 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 NCT04762069.
About Berubicin
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 portfolio, 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.
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 timing of enrollment of
new patients and the ability of the Company to complete the trial
on a timely basis, if at all. 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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