HOUSTON, Aug. 20, 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 it has engaged
Worldwide Clinical Trials ("Worldwide") as the contract research
organization ("CRO") for its upcoming Berubicin clinical
trials.
Worldwide is a a full-service, midsize, global CRO that provides
drug development services to biopharmaceutical companies in
clinical trials. Worldwide specializes in therapeutic areas where
there remain unmet medical needs, including CNS disorders and
oncology. Worldwide provides proactive insight and operational
support and has successfully managed clinical trials across more
than 60 countries.
"Designing and operating trials in areas of high unmet medical
need, such as glioblastoma, is a challenging and complex task for
any company. We are excited to bring on a high caliber partner such
as Worldwide, which has extensive expertise in CNS and oncology, as
our CRO for the upcoming Berubicin clinical trials," commented
John Climaco, CEO of CNS
Pharmaceuticals. "Engaging Worldwide is one of the key pieces of
our preparations. We maintain that their insight and unparalleled
experience in trials of this nature provide the best opportunity to
further drive Berubicin's clinical development. We believe that
with Worldwide's deep clinical CNS and oncology experience, and
through our achievements in trial preparation, we are optimally
positioned for our upcoming Phase II Berubicin trials in adults in
the US and Poland as well as our
Phase I pediatric trial."
"The relationship between CNS Pharmaceuticals and Worldwide
exemplifies state-of-the-art strategic program development –
innovative program design coupled to exceptional clinical and
operational acumen for a compound that offers considerable promise
to both adults as well as children with such devastating
illnesses," commented Michael F.
Murphy, MD, PhD, Chief Medical and Scientific Officer at
Worldwide. "Speaking on behalf of our organization, it is a
privilege to express our personal and professional commitment to
its success."
The Company's decision to engage Worldwide as its CRO for the
upcoming Berubicin clinical trials is the latest milestone in a
series of recent preparation achievements. The Company has been
active in implementing its strategic plan and engaged US-based
Pharmaceutics International, Inc., (Pii) and Italy-based BSP Pharmaceuticals S.p.A., (BSP)
for the production of Berubicin drug product. The decision to add
both Pii and BSP as manufacturers of Berubicin was part of the
Company's strategy to implement a dual-track drug product
manufacturing strategy. The Company believes this dual-track
strategy will help mitigate COVID-19 related risks, diversify its
supply chain, and provide for localized availability of Berubicin.
Furthermore, CNS completed synthesis of Berubicin Active
Pharmaceutical Ingredient (API) and shipped API to both
manufacturers to prepare an injectable form of Berubicin for
clinical 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 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.
About Worldwide Clinical Trials
Worldwide Clinical
Trials employs more than 1,700 professionals around the world, with
offices in North and South
America, Eastern and Western
Europe, Russia, and
Asia. Founded by physicians
committed to advancing medical science, Worldwide is out to change
how the world experiences CROs—in the best possible way. From early
phase and bioanalytical sciences through late phase, post-approval
and real-world evidence, we provide world-class, full-service drug
development services.
With infrastructure and talent spanning 60 countries, we execute
predictable, successful studies with operational excellence across
a range of therapeutic areas, including central nervous system,
cardiovascular, metabolic, general medicine, oncology and rare
diseases. We never compromise on science or safety. We're never
satisfied with the status quo. We're the Cure for the Common
CRO.
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 initiate
its Phase 2 trial by the end 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.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/cns-pharmaceuticals-engages-cro-for-phase-2-berubicin-clinical-trials-301115272.html
SOURCE CNS Pharmaceuticals, Inc.