Data recently presented at the Society for
Neuro-Oncology (SNO) 27th Annual Meeting
Preliminary results showcase updated patient
population profile and safety
Continued progress toward planned interim
analysis when 30-50% of subjects are evaluable at 6 months after
enrollment on the study, expected mid-year 2023
HOUSTON, Dec. 8, 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
preliminary results from its ongoing potentially pivotal trial
evaluating Berubicin for the treatment of recurrent glioblastoma
multiforme (GBM).
![(PRNewsfoto/CNS Pharmaceuticals, Inc.) (PRNewsfoto/CNS Pharmaceuticals, Inc.)](https://mma.prnewswire.com/media/1120277/CNS_Pharmaceuticals_Logo.jpg)
"Although data are still early, we are pleased with these
results in terms of recruiting a balanced patient population to
compare Berubicin to Lomustine in the treatment of GBM, which may
highlight Berubicin's potential to provide a better therapeutic
option for patients after first-line therapy for their disease. We
remain steadfast in our efforts to drive patient enrollment across
the U.S. and Europe and are making
significant progress toward our planned interim analysis, which we
expect to occur in mid-2023. Our team remains dedicated to moving
this important program forward and to providing patients, families
and physicians with a much needed treatment opportunity for this
devastating disease," commented John
Climaco, CEO of CNS Pharmaceuticals.
"Berubicin continues to demonstrate its ability to be an
innovative treatment in GBM as a safe and potentially effective
therapy. These preliminary findings bolster our conviction in
Berubicin as we continue to advance this study forward. Based on
the results we've seen preclinically and in the clinic thus far, we
remain confident in Berubicin's potential to provide a
consequential and much needed clinical benefit for GBM patients. We
are making excellent progress with patient recruitment worldwide
and, because we have currently described a balanced randomized
population, we look forward to providing a meaningful comparison
between Berubicin and what has been considered a standard of care
for second line therapy (Lomustine)," added Sandra Silberman, MD, PhD, Chief Medical Officer
of CNS Pharmaceuticals.
The preliminary results showed that the enrolled patients have
comparable demographics, including age, gender, race, BSA and KPS
and, in addition, the unmethylated MGMT population, which was
approximately 40% in both arms. The percentage of patients that are
currently continuing on study or having withdrawn is also
comparable between arms. All grades of adverse events occurring in
more than 5% of patients, as well as Grade 3-5 events, were also
similar in the Berubicin and Lomustine arms.
As of the data cutoff of October 17,
2022, 49 patients were enrolled in this potentially pivotal
trial with 35 subjects on Berubicin and 14 subjects on Lomustine,
reflective of the Company's 2:1 randomization schema. This study is
evaluating the efficacy of this novel drug in terms of overall
survival (OS), with the goal of providing the first approved
therapeutic option for patients after first-line therapy. A
pre-planned, non-binding futility analysis of OS will be performed
after approximately 30 to 50% of all planned patients are enrolled
in the study. These patients will be evaluated at 6 months after
enrollment in the study, which we expect mid-year 2023. This review
will include additional evaluation of safety as well as secondary
efficacy endpoints related to the efficacy of Berubicin. Enrollment
will not be paused during this interim analysis.
The data were recently presented by Dr. Silberman at the Society
of Neuro-Oncology's 27th Annual Meeting in a poster
titled, "A Randomized, Controlled Trial of Berubicin, a
Doxorubicin Analog That Effectively Crosses the Blood-Brain Barrier
(BBB), After First-Line Therapy for Glioblastoma Multiforme (GBM):
Preliminary Results1."
The Company can now report that subsequent to Dr. Silberman's
presentation at the Society of Neuro-Oncology's 27th Annual
Meeting, enrollment has increased to 67 patients in this
potentially pivotal study. "It is a remarkable testament to
both the design of our study and the magnitude of the unmet
clinical need in this terrible disease that our study is enrolling
at this rapid pace. We are extremely grateful to our
patients, our investigators and to our investors who are all
facilitating this potentially game-changing clinical program," said
John Climaco, Chairman and CEO of
CNS Pharmaceuticals, Inc.
For more information about the ongoing 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. The FDA has granted CNS Pharmaceuticals
Fast Track Designation and Orphan Drug Designation for
Berubicin.
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 the WP1244 portfolio 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 include,
without limitation, the Company's ability to drive patient
enrollment across the U.S. and Europe and the timing of the planned interim
analysis to occur in mid-2023. 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 https://doi.org/10.1093/neuonc/noac209.317
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