HOUSTON, Sept. 30, 2021 /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 dosing of the first
patients in its Berubicin clinical development program for the
treatment of recurrent glioblastoma multiforme (GBM), one of the
most aggressive types of brain cancer. Further patient enrollment,
randomization and dosing is currently underway as well as a robust
lineup of clinical sites located globally which are advancing
toward activation and enrollment.
"As one of the most aggressive, deadly and treatment-resistant
cancers that forms in the brain where current standard of care
remains ineffective in ~60% of patients, the treatment landscape
for GBM is in desperate need of a better treatment option. We
continue to be encouraged by the data seen from Berubicin to date
and are excited to now have patient dosing underway in this
potentially pivotal trial. Our team is committed to expeditiously
advancing the study and look forward to further understanding the
full potential of Berubicin to offer improvement and overall
survival in this devastating disease," stated Erin Dunbar, M.D., founding physician of the
Brain Tumor Center and Director of Neuro-Oncology at Piedmont
Atlanta Hospital, and Principal Investigator for the study.
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. 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.
In the Phase 1 clinical trial previously conducted
evaluating Berubicin in patients with previously treated disease,
44% of the patients showed clinical benefit (49% of the
Avastin-naïve patient population), with the demonstration that it
was effective based on this patient population with a dismal median
survival rate of only 14.6 months from diagnosis. One patient in
the Phase 1 study had a durable Complete Response (CR, a
demonstrated lack of detectable cancer cells) that has continued
for 14 years, and another patient had a durable partial response,
with others showing substantial stabilization of disease.
Additionally, the novel anthracycline agent Berubicin appears to
have a toxicity profile consistent with that of other
anthracyclines and demonstrates activity as monotherapy for
recurrent glioblastoma multiforme. Berubicin has side effects that
are able to be effectively treated and managed.
"I am extremely pleased with the progress made to-date in this
potentially pivotal trial. Our team has been working intensely to
open sites in the U.S. and in Europe, understanding where we can best
advance this important study. With hundreds of potentially
competing GBM trials currently enrolling patients, the fact that
we've been able to bring these initial sites on-line and get
patients enrolled and dosed not only supports our strategic
evaluation and selection, but also allows our data demonstrating
Berubicin's potential effectiveness to continue to convince the
medical community that we have a new drug with impressive
potential. With the de-risked profile of Berubicin, its mechanism
of action, history of development, encouraging Phase 1 data, and
safety in study design, I am personally more optimistic about our
work than at any time since joining the Company," commented
John Climaco, CEO of CNS
Pharmaceuticals.
"The investigator dedication to advance the science and
development of Berubicin we're seeing here is meaningful to these
patients that are out of options. Berubicin provides an innovative
option for treatment in GBM as a safe and potentially effective
therapy. We look forward to providing data at the interim analysis
of the study," added Sandra L. Silberman, M.D., Ph.D. Chief Medical
Officer of CNS Pharmaceuticals.
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. Taken together the Company
believes these important designations can be seen as a recognition
of the significance of not only the unmet clinical need in GBM, but
of our Berubicin program.
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, 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 ability of the Company's
cash runway to extend until Q2 2022 and the timing of patient
dosing to commence. 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.