HOUSTON, Aug. 25, 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 provided an update on
the Company's plans for its lead product candidate,
Berubicin, which is being studied for the treatment of glioblastoma
multiforme (GBM). The company has taken significant strides in
designing Phase 2 clinical trials and anticipates submitting an
Investigational New Drug application (IND) to the U.S. Food and
Drug Administration (FDA) this year and initiating clinical trials
in early 2021. In preparing for the IND submission, CNS has focused
on clinical trial design and implementation, as well as
establishing the necessary manufacturing capabilities.
On the clinical front, the Company has engaged Worldwide
Clinical Trials (Worldwide) as the contract research organization
(CRO) that will be conducting the upcoming Berubicin clinical
trials. Worldwide, which specializes in therapeutic areas with
unmet medical needs, including CNS disorders and oncology, will
work closely with CNS to provide proactive insight and operational
support. . In addition, the Company has engaged Berry Consultants,
a leading clinical statistical consulting group, to advise on the
Phase 2 trial design. Berry Consultants utilizes Bayesian
statistics to provide innovative clinical trial designs and
analysis. In preparation for submitting the IND, CNS also has
completed the Clinical Study Report, or CSR, for a Phase 1 study
for which the Company holds the rights.
CNS also has made several key advances in drug manufacturing,
with the goal of ensuring the quality and availability of Berubicin
for the upcoming clinical trials. As part of a dual track product
manufacturing strategy, CNS has engaged US-based Pharmaceutics
International, Inc., (Pii) and Italy-based BSP Pharmaceuticals S.p.A., (BSP)
to produce the Berubicin finished drug product. CNS believes this
strategy will help mitigate COVID-19 related risks, diversify the
Company's supply chain, and provide for localized availability of
Berubicin. The Company completed synthesis of Berubicin active
pharmaceutical ingredient (API) and shipped API to both
manufacturers to prepare an injectable form of Berubicin for
clinical use.
"We are extremely encouraged by the consistent progress we have
made in preparation for our upcoming Berubicin clinical trials,"
commented John Climaco, CEO of CNS
Pharmaceuticals. "The CNS team is deeply experienced in the design
and execution of clinical trials and as a result of our
preparations, we have continued to deliver upon our strategic
timeline and remain on track to execute our upcoming milestones. We
believe our efforts optimally position us to submit an IND for
Berubicin in the fourth quarter of this year." Unless FDA
acts to the contrary, an IND goes into effect 30 calendar days
after submission to the agency, which allows the sponsor to
initiate the clinical trial presented in the IND.
FDA recently granted the Company Orphan Drug Designation (ODD)
for Berubicin for the treatment of malignant gliomas, which include
GBM. The designation provides Berubicin with certain benefits
during the product's development to treat malignant gliomas and
provides CNS with the potential for market exclusivity upon the
drug's approval for that use.
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, 44% of patients experienced
a statistically significant improvement in clinical benefit. 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 February 20, 2020.
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 GBM trial in adults and a
first-ever Phase 1 trial in pediatric GBM patients in Poland.
The Company's second drug candidate, WP1244, is a novel DNA binding
agent that in preclinical studies has shown promising potency in
inhibiting tumor cell proliferation.
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 file an
IND for Berubicin during the fourth quarter of 2020. 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
in the Company's SEC filings, including under Item 1A. "Risk
Factors" in our most recently filed Form 10-K filed with the
Securities and Exchange Commission ("SEC") and updated from time to
time in our Form 10-Q filings and in our 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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SOURCE CNS Pharmaceuticals, Inc.