CNS Pharmaceuticals Announces US Drug Manufacturing Milestones
September 03 2020 - 8:00AM
via NetworkWire – 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 central nervous system, today
provides an update on progress for the U.S. manufacturing of
Berubicin, the Company’s lead drug candidate, in preparation for
upcoming clinical trials.
As previously announced, the Company implemented a dual-track
drug product manufacturing strategy and engaged U.S.-based
Pharmaceutics International, Inc. (“Pii”) and Italy-based BSP
Pharmaceuticals S.p.A. (“BSP”) for the production of Berubicin.
By engaging two separate manufacturers on two separate
continents, CNS expects to mitigate COVID-19-related delay risks,
diversify its supply chain and provide for localized availability
of Berubicin.
Under this dual-track strategy, the Company has achieved several
key milestones in its manufacturing efforts and is providing an
update on the progress made with its U.S. manufacturer, Pii. First,
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. In preparation
for production, CNS and Pii have now agreed on the manufacturing
procedure and packaging components for Berubicin and selected a
sterile filter manufacturer. The Company has also completed and
reviewed a draft of the batch record. Importantly, the Company and
Pii completed a successful laboratory simulation of the
lyophilization cycle. The Company expects to begin manufacturing of
Berubicin at Pii during the third quarter of this year.
“As we prepare to initiate our upcoming Berubicin clinical
trials, our execution both on the clinical and manufacturing fronts
remain paramount to our success," stated John Climaco, CEO of CNS
Pharmaceuticals. "We continue to be encouraged as our partner Pii
has now delivered upon many of the critical steps necessary to
ensure the quality and availability of Berubicin. We look forward
to keeping you updated on our progress as we continue our
preparations to submit an IND for Berubicin during the fourth
quarter of this year.”
CNS’s preparations for filing an IND entail both extensive
clinical and manufacturing initiatives. In addition to the progress
the Company has made in its manufacturing efforts, it has recently
announced critical achievements made on the clinical front. The
Company engaged Worldwide Clinical Trials (“Worldwide”) as the
contract research organization (CRO) for its upcoming Berubicin
clinical trials. Worldwide specializes in therapeutic areas with
unmet medical needs, including CNS disorders and oncology.
Worldwide will work closely with CNS to provide proactive insight
and operational support for its upcoming trials. Additionally, the
Company engaged Berry Consultants, a leading clinical statistical
consulting group, to advise on its Phase 2 trial design for
Berubicin. Berry Consultants uses Bayesian statistics to provide
innovative clinical trial designs and analysis. The Company has
also completed the Phase 1 Clinical Study Report, or CSR, which is
now ready for publication.
CNS was recently granted Orphan Drug Designation (ODD) for its
lead product, Berubicin, for the treatment of malignant gliomas.
The designation provides Berubicin with a special status that can
help accelerate its development to treat malignant gliomas by
providing CNS with the potential for market exclusivity upon the
drug's approval. The Company plans to file an IND for Berubicin
with the FDA during the fourth quarter of 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, 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. 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.
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.
CONTACTS:Investor Relations
ContactJames Salierno The Ruth Group 646-536-7028 / 7032
jsalierno@theruthgroup.com
Media Contact Kirsten Thomas The Ruth Group
(508) 280-6592 kthomas@theruthgroup.com
Corporate Communications:InvestorBrandNetwork
(IBN) Los Angeles, California www.InvestorBrandNetwork.com
310.299.1717 Office Editor@InvestorBrandNetwork.com
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