HOUSTON, Feb. 25, 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
of the brain and central nervous system, today indicated that the
clinical program for Berubicin is on track to start enrolling
patients in March 2021. 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.
Preparations are proceeding on schedule for the Company's study
evaluating the efficacy of Berubicin in the treatment of GBM. The
Company intends to enroll subjects across approximately 35 clinical
sites in the U.S., with 21 sites currently confirmed and in a
start-up process. The Company also plans to expand the trial
into western Europe.
"I am very pleased with our progress and the team's execution
towards the start of our program. We have made significant
advancements and are now finalizing clinical site selection and
preparing to begin patient screening, which we expect to commence
next month," commented John Climaco,
CEO of CNS Pharmaceuticals. "Berubicin's promising results
demonstrated in the Phase 1 clinical trial build on sixty years of
clinical experience with anthracyclines. Berubicin is an
entirely novel molecule that represents an opportunity to recognize
the powerful benefits of this tried-and-true class of drugs for
neuro-oncology in general and in the fight against GBM in
particular. We are deeply committed to driving this program forward
as expeditiously as possible with the prime focus on our mission to
improve patient outcomes for GBM."
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. For more information about
the trial, visit clinicatrials.gov (identifier NCT04762069).
"With a dismal survival rate of only 14.6 months from diagnosis,
and no currently approved second-line therapies for GBM, there
remains an urgent, critical need in the treatment landscape for
glioblastoma, one of the most aggressive, deadly and resistant
cancers that form in the brain. GBM patients are in need of hope
for a treatment that can offer improvement in progression free as
well as overall survival. Given our current understanding of the
promise of Berubicin, our trial design could be the best
opportunity to provide the FDA with data demonstrating an effective
treatment option. We look forward to beginning patient screening in
the coming weeks and learning more about Berubicin in the treatment
of GBM," added Dr. Sandra Silberman,
CMO of CNS Pharmaceuticals.
Anticipated Upcoming Milestones:
- Patient screening in the Company's clinical trial for the
treatment of glioblastoma will start in March 2021 with the first patient dosed shortly
thereafter;
- Our sublicensee partner in Poland, WPD Pharmaceuticals, will initiate a
Phase 2 multicenter clinical trial of Berubicin in GBM in the first
half of 2021;
- The WPD trial in adults with GBM will include an interim
analysis of the first 18 patients by Q4 2021 for efficacy as well
as an extensive pharmacokinetic profile in these patients;
- WPD will commence a multicenter Phase 1 pediatric trial for
malignant CNS tumors in 2021;
- CNS will conduct pre-clinical evaluation of Berubicin for
additional CNS cancers and cancers metastatic to the brain,
including development of potential combination therapies for these
indications; and
- CNS will expand our pipeline in the evaluation of other drugs
for brain cancers.
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.