Enrollment progressing toward interim
analysis, planned when 30-50% of subjects reach 6 months in
study
HOUSTON, Nov. 2, 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 first patient in Europe has
been enrolled and dosed in France
in the Company's ongoing potentially pivotal global trial
evaluating Berubicin for the treatment of recurrent glioblastoma
multiforme (GBM), an aggressive and incurable form of brain
cancer.
The Company has opened 29 clinical trial sites of the 68 sites
selected across the U.S., Italy,
France, Spain, and Switzerland. 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.
"Our team has worked tirelessly to expand the presence of our
clinical trial for Berubicin on a global scale. To have enrolled
and dosed our first patient in France shortly after the opening the site is a
noteworthy accomplishment and a testament to our team's dedication
to drive the program forward. I am pleased with the progress made
and remain committed to building on this momentum. We expect to
enroll and dose additional patients across our clinical trial sites
in Europe and advance toward the
much-anticipated inflection point which is the interim analysis,"
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. For more
information about the potentially pivotal Berubicin trial, visit
clinicaltrials.gov and reference identifier NCT04762069.
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.
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 Company's ability to
enroll and dose additional patients across clinical trial sites in
Europe on a timely basis. 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.