Expanded eligibility for patients who have
received multiple therapies as first line therapy for GBM
Company continues to enroll patients for the
trial with 19 clinical trial sites open to-date, and an additional
42 sites selected across the U.S., Italy, France, Spain, and Switzerland that will be initiated and
enrolling soon
Interim analysis of the trial when 30- 50% of
subjects reach 6 months in study
HOUSTON, June 23,
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 that it has received approval from the U.S.
Food and Drug Administration (FDA) for its ongoing potentially
pivotal global study evaluating the efficacy and safety of
Berubicin compared with Lomustine (Gleostine) administered after
first line therapy for the treatment of recurrent glioblastoma
multiforme (GBM), one of the most aggressive types of brain
cancer.
"We are pleased to have received this positive response from the
FDA and to continue driving the Berubicin clinical development
program forward. The key objectives for the protocol amendment are
based on the feedback we received from investigators and further
consideration of the needs of patients on the study. We have also
incorporated the recent WHO classification of
glioblastoma1 with pertinent guidelines, ensuring that
these patients meet specific criteria that allows us to accurately
position the program for success. I am proud of the progress we
continue to make on the clinical and regulatory fronts and look
forward to further advancing this important trial," commented
John Climaco, CEO of CNS
Pharmaceuticals.
Berubicin is a novel anthracycline and the first anthracycline
to appear to cross the blood-brain barrier currently being
evaluated in a global potentially pivotal study evaluating its
efficacy and safety.
The potentially pivotal 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. 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 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 30 to 50% of all planned patients have completed 6 months on
therapy. This evaluation will include safety as well as secondary
efficacy endpoints. Enrollment will not be paused during this
interim analysis.
"The operational objectives of this study remain our priority,
including using patient reported outcomes, stratification based on
MGMT methylation status (a prognostic factor in glioblastomas), and
providing both the study drug, Berubicin, as well as the comparator
drug, Lomustine, to all sites. With the recent regulatory authority
approvals received in Europe, we
are currently on the cusp of opening clinical sites globally,
including France, Italy, Spain,
and Switzerland, to expand the
scope and outreach to patients for this trial. We remain dedicated
to driving this study forward and ultimately hope to provide a
much-needed option for treatment in GBM as a safe and effective
therapy," added Sandra L. Silberman,
M.D., Ph.D. Chief Medical Officer of CNS Pharmaceuticals.
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 opening new
sites in Europe. 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.
1 WHO Classification of Tumours Editorial Board.
World Health Organization Classification of Tumours of the
Central Nervous System. 5th ed. Lyon: International Agency for Research on
Cancer; 2021
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