HOUSTON, Oct. 29, 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 announces that its European
manufacturer, BSP Pharmaceuticals S.p.A. ("BSP"), has completed the
manufacturing process for Berubicin Drug Product, its lead drug
candidate for the treatment of glioblastoma multiforme (GBM), an
aggressive form of brain cancer currently considered incurable.
With the completion of manufacturing at BSP and at its U.S.
manufacturer, Pharmaceutics International, Inc. ("Pii"), the
Company remains poised to file an Investigational New Drug
Application ("IND") and initiate its Phase 2 U.S. clinical trial
for Berubicin on its anticipated timeline.
"We are pleased to continue to execute upon our dual-track drug
product manufacturing strategy, as both our U.S. manufacturer, Pii,
and European manufacturer, BSP, have now completed production of
Berubicin Drug Product," commented John
Climaco, CEO of CNS Pharmaceuticals. "The completion of the
manufacturing process at both locations represents a key milestone
for us and will further support our efforts to file an IND during
the fourth quarter of this year. We are encouraged by our continued
execution upon our pre-trial initiatives, and believe we remain
positioned to initiate a U.S. Phase 2 trial for Berubicin during
the first quarter of 2021."
As previously announced, the Company implemented its dual-track
drug product manufacturing strategy for Berubicin. As a part of its
strategy, the Company engaged a U.S. based manufacturer, Pii, and
European manufacturer BSP, for the production of Berubicin Drug
Product. The Company engaged two separate manufacturers in two
separate continents in order to help mitigate COVID-19-related
delay risks, diversify its supply chain and provide for localized
availability of Berubicin. Both Pii and BSP have now completed the
manufacturing process for Berubicin.
As the Company focuses on its IND filing preparations, it has
made several key advancements on the clinical front to supplement
its manufacturing efforts. The Company recently engaged Worldwide
Clinical Trials as the contract research organization, Image
Analysis Group ("IAG") as the imaging partner, and Berry
Consultants as a biostatistical advisor for its Phase 2 trial
design. Furthermore, the Company also bolstered its leadership team
in advance of the trial and appointed Dr. Patrick Wen, a renowned neuro-oncologist, to its
Scientific Advisory Board. The FDA 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 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
file an IND in the fourth quarter of this year and to initiate its
Phase 2 trial for Berubicin in the first quarter of 2021. 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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SOURCE CNS Pharmaceuticals, Inc.