HOUSTON, Nov. 12, 2020 /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 announced its presentation to discuss
the clinical trial design for its upcoming Phase 2 U.S. trial for
Berubicin, its lead drug candidate for the treatment of
glioblastoma multiforme (GBM), will be available via webcast today
at 4:30pm ET. The discussion will be
moderated by Robert LeBoyer,
Managing Director of Equity Research at Ladenburg Thalmann &
Co., Inc.
The Company plans to submit an Investigational New Drug (IND)
application to the U.S. Food & Drug Administration (FDA), which
includes a novel clinical trial designed to build on the
encouraging results observed in a prior Phase 1. The Phase 2 trial
will randomize patients to Berubicin or standard of care. This
upcoming trial will include interim assessments that will evaluate
the comparative safety and effectiveness of these treatments with
an adaptive design intended to complete a thorough investigation
into Berubicin as expeditiously as possible.
Details of the webcast are below:
Date:
November 12th, 2020
Time:
4:30 PM ET
Link:
https://cnspharma.com/webcast-november-2020/
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. By the end of 2020, 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 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.
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 to
seek accelerated approval from the FDA of a New Drug Application
(NDA) following the planned Berubicin trial. 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.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/cns-pharmaceuticals-to-discuss-phase-2-clinical-trial-design-to-be-submitted-for-fda-review-in-webcast-at-430-pm-et-today-301171565.html
SOURCE CNS Pharmaceuticals, Inc.