HOUSTON, May 19, 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 open
enrollment for its potentially pivotal study evaluating the
efficacy and safety of Berubicin in the treatment of recurrent
GBM.
CNS' lead product candidate, Berubicin, is a novel anthracycline
and the first anthracycline to cross the blood-brain barrier. It is
in development for the treatment of a number of serious brain and
CNS oncology indications. The Company intends to enroll
approximately 210 subjects across 35 clinical sites in the U.S. and
also plans to expand the trial into western Europe. For more information about the
potentially pivotal Berubicin trial, visit clinicaltrials.gov and
reference identifier NCT04762069.
"We are delighted to begin patient enrollment and screening in
this potentially pivotal trial that will provide greater insight
into the potential of Berubicin to improve patient outcomes in the
treatment of GBM. This represents an important milestone for our
pivotal program," commented John
Climaco, CEO of CNS Pharmaceuticals. "I would like to thank
our clinical team for their commitment and drive to advance this
important development program."
"There remains a critical unmet need in the treatment landscape
for glioblastoma. The data seen to date from Berubicin is
encouraging as a potential treatment option in this devastating
disease. With patient enrollment now underway and dosing to
commence soon hereafter, we are another step closer to providing
patients with hope and a treatment that offers improvement in
progression and, importantly, overall survival," added Erin Dunbar, MD, founding physician of the Brain
Tumor Center and Director of Neuro-Oncology at Piedmont Atlanta
Hospital, and Principle Investigator for the study.
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. 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.
Results from the trial will compare Berubicin to the current
standard of care, with a 2 to 1 randomization of patients to
receive either Berubicin or Lomustine.
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.
In addition to the Company's global trial, sublicensee partner
in Poland, WPD Pharmaceuticals,
will initiate a Phase 2 multicenter clinical trial of Berubicin in
adult GBM in the second half of 2021 as well as a Phase 1
multicenter clinical trial of Berubicin in pediatric gliomas in
2021. The WPD trial in adults with GBM will include an interim
analysis of the first 18 patients in the first half of 2022 for
efficacy and safety as well as an extensive pharmacokinetic profile
for these patients.
The FDA has granted CNS Pharmaceuticals Orphan Drug Designation
for Berubicin, which provides seven years of marketing exclusivity
upon approval of an NDA. CNS Pharmaceuticals intends to file
for additional patents relating to Berubicin to further secure
intellectual property protections.
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 is developing novel treatments for primary
and metastatic cancers of the brain and central nervous system. Its
lead drug candidate, Berubicin, is proposed for the treatment of
glioblastoma multiforme (GBM), an aggressive and incurable form of
brain cancer. CNS holds a worldwide exclusive license to the
Berubicin chemical compound and has acquired all data and know-how
from Reata Pharmaceuticals, Inc. related to a completed Phase 1
clinical trial with Berubicin in malignant brain tumors, which
Reata conducted in 2006. In this trial the overall response rate of
stable disease or better was 44%. This 44% disease control rate was
based on 11 patients (out of 25 evaluable patients) with stable
disease, plus responders. One patient experienced a durable
complete response and remains cancer-free as of Feb. 20, 2020. These Phase 1 results represent a
limited patient sample size and, while promising, are not a
guarantee that similar results will be achieved in subsequent
trials. During 2021, CNS expects to commence a Phase 2 clinical
trial of Berubicin for the treatment of GBM in the U.S., while a
sub-licensee partner undertakes a Phase 2 trial (with extensive PK)
in adults and a first-ever Phase 1 trial in pediatric GBM patients
in Poland. Its second drug
candidate, WP1244, is a novel DNA binding agent that has shown in
preclinical studies that it is 500 times more potent than the
chemotherapeutic agent daunorubicin in inhibiting tumor cell
proliferation.
For more information, please visit www.CNSPharma.com.
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SOURCE CNS Pharmaceuticals, Inc.