Continued advancement of global patient
enrollment with Switzerland,
France, and Spain approvals received for pivotal study of
Berubicin
HOUSTON, April 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 it has received approval from the Spanish
Agency for Medicines and Health Products (AEMPS) Competent
Authority and from the CElm Provincial de Sevilla Ethics Committee
in Spain for the Company's
potentially pivotal study of Berubicin for the treatment of
recurrent glioblastoma multiforme (GBM), one of the most aggressive
types of brain cancer.
"We continue to build momentum in our potentially pivotal study
of Berubicin, and importantly advance toward bringing a much needed
treatment option to patients. We have significantly bolstered our
international presence and we are grateful to Spain for joining us in support of this trial.
We are committed to driving this development program forward and
are executing on all fronts to build momentum," commented
John Climaco, CEO of CNS
Pharmaceuticals.
Dr. Juan M Sepúlveda Sánchez, MD, 12 de Octubre University
Hospital, Madrid, added, "There
remains a significant unmet medical need for patients with GBM. We
are pleased to bring this important clinical program to
Spain and help to further evaluate
Berubicin's potential to meet that need. I look forward to working
alongside the rest of the clinical team to advance CNS
Pharmaceuticals' potentially pivotal study and importantly,
progress Berubicin through the clinic with the hope of bringing a
valuable treatment options to patients and physicians."
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. 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
interim analysis.
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
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. 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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