Study to evaluate Berubicin for the treatment
of newly diagnosed and relapsed/refractory primary central nervous
system lymphoma (PCNSL) or non-Hodgkin's lymphoma with central
nervous system involvement (NHL-CNSI)
HOUSTON, Jan. 12,
2023 /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 an investigator-initiated Phase
1b/2 trial evaluating the Company's
novel anthracycline, Berubicin, which will be conducted at the
Pomeranian Medical University (PUM) in Szczecin, Poland.
![(PRNewsfoto/CNS Pharmaceuticals, Inc.) (PRNewsfoto/CNS Pharmaceuticals, Inc.)](https://mma.prnewswire.com/media/1120277/CNS_Pharmaceuticals_Logo.jpg)
The study, titled "Evaluation of the safety and efficacy of
Berubicin in the treatment of central nervous system
lymphomas," will be a single center, single-arm, open-label
Phase 1b/2 clinical trial assessing
the efficacy, safety, and pharmacokinetics of Berubicin in a
multidrug treatment regimen for adult patients with newly diagnosed
or relapsed/refractory primary central nervous system lymphoma
(PCNSL) and non-Hodgkin's lymphoma with central nervous system
involvement (NHL-CNSI). The primary efficacy endpoint for the study
is to evaluate the safety and tolerability of Berubicin in
combination with other cytostatic agents and to determine the
recommended Phase 2 dose (RP2D) of Berubicin.
"Based on the data seen to date, Berubicin has continued to
demonstrate an overall safety profile more favorable than other
known anthracyclines and we remain encouraged by its potential. We
are committed to Berubicin's continued development as a much-needed
oncology tool and are therefore providing the study drug to the PUM
for their Phase 1b/2 clinical study.
Given the unmet needs and current prognosis for CNS lymphomas, the
optimal treatment strategy is to improve overall survival, to which
we believe Berubicin can contribute. We look forward to further
understanding the potential of Berubicin in this disease and the
findings from this study," commented John
Climaco, CEO of CNS Pharmaceuticals.
Patients enrolled in the investigator-initiated Phase
1b/2 study will receive Berubicin in
escalated doses in an accelerated model assigning one patient per
cohort, which will reduce the number of patients that may be
treated with sub-therapeutic doses. The purpose of the dose
escalation strategy is to evaluate dose limiting toxicities (DLT)
and establish the appropriate dose to utilize into Phase 2
(recommended Phase 2 dose, RP2D). The initial escalation by 40% in
the next cohorts will be based on safety assessments. After
completing a treatment cycle, if a patient does not have any DLTs,
they can proceed to the next dose level, and additional patients
can be enrolled to explore higher doses. If any patient experiences
DLT, that dosing cohort will be expanded to 3 patients. If 2
patients develop DLT, the given dose will be considered toxic and
the next cohort will start treatment at a dose reduced by 20%.
After considering the data from the Phase 1 clinical trial in
patients with CNS gliomas, treatment of patients with CNS lymphomas
is planned to start with a higher initial dose of Berubicin (4.8
mg/m2).
A total of up to approximately 60 patients are planned to be
enrolled. The minimum participation in the study for an individual
patient is approximately 21 weeks. After the end-of-treatment
follow-up visit, patients will enter a post-study follow-up period
of up to 3 years.
Berubicin is currently being evaluated for efficacy and safety
in the treatment of glioblastoma multiforme (GBM), an aggressive
and incurable form of brain cancer, by CNS Pharmaceuticals in
an ongoing, potentially pivotal global study. 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.
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. . 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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