HOUSTON, June 29, 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 that the
U.S. Food and Drug Administration (FDA) granted Fast Track
Designation for its lead investigational drug, Berubicin, for the
treatment of patients with recurrent glioblastoma multiforme (GBM).
As previously reported, the Company has also received Orphan Drug
Designation from the FDA for Berubicin for the treatment of
patients with recurrent GBM.
"Receiving Fast Track Designation from the U.S. FDA is a huge
achievement in our advancement of Berubicin for the treatment of
glioblastoma, the most aggressive, deadly and treatment-resistant
type of cancer that forms in the brain. If there were ever a
disease where the unmet clinical need demands action, it is GBM.
Patients have almost no meaningful options and thousands lose their
fight against this terrible cancer every year. With this
designation, we now have an accelerated pathway to approval for
Berubicin and a clear opportunity to more expediently bring this
potentially impactful investigational therapy to individuals
battling this challenging disease," commented John Climaco, CEO of CNS Pharmaceuticals.
Fast Track Designation enables more frequent interactions with
the FDA to expedite the development and review process for drugs
intended to treat serious or life-threatening conditions and that
demonstrate the potential to address unmet medical need.
CNS recently announced the start of patient enrollment in its
potentially pivotal study of Berubicin for the treatment of
recurrent glioblastoma multiforme. For more information about this
study, please 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.
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SOURCE CNS Pharmaceuticals, Inc.