HOUSTON, April 23, 2020 /PRNewswire/ -- CNS
Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the
"Company"), a biotechnology company specializing in the
development of novel treatments for brain tumors, today announced
it has filed an application with the U.S. Food and Drug
Administration (FDA) to receive Orphan Drug Designation (ODD) for
its lead product Berubicin.
Under a prior developer, Berubicin, then known as RTA 744, was
granted ODD by the FDA for the treatment of malignant gliomas. In
the prior developer's Phase 1 trial of Berubicin, 44% of the
patients demonstrated a significant improvement in progression free
survival. Additionally, one patient in this study experienced a
complete response to his treatment with Berubicin.
"We are excited to announce the Orphan Drug application
submission for Berubicin, as it would grant special status and
accelerate the development of Berubicin to treat glioblastoma, one
of the world's most aggressive forms of cancer," stated
John Climaco, CEO of CNS
Pharmaceuticals. "We are pleased to continue to execute upon our
strategic initiatives and submit our application within the
anticipated timeline outlined within our previous filings. We feel
cautiously optimistic about the application, given the past Orphan
Drug Designation of the molecule and positive Phase 1 results. We
look forward to initiating a Phase II trial evaluating the effect
of Berubicin on patients with glioblastoma later this year."
The Orphan Drug Act ("ODA") provides for granting special status
to a drug or biological product to treat a rare disease or
condition upon request of a sponsor. This status is referred to as
orphan designation (or sometimes "orphan status").
The FDA grants Orphan Drug Designation status to products that
treat rare diseases, providing incentives to sponsors developing
drugs or biologics. The FDA defines rare diseases as those
affecting fewer than 200,000 people in the United States at any given time. Due to
small patient numbers, treatment for these rare diseases would not
be considered economically feasible without government programs to
support their economic viability. Orphan Drug Designation would
qualify Berubicin for certain benefits and incentives, including
seven years of marketing exclusivity if regulatory approval is
ultimately received for the designated indication, potential tax
credits for certain activities, eligibility for orphan drug grants,
and the waiver of certain administrative fees. The receipt of
Orphan Drug Designation status does not change the regulatory
requirements or process for obtaining marketing approval.
About Berubicin
Berubicin is an anthracycline, a class
of anticancer agents that are among the most powerful chemotherapy
drugs and effective against more types of cancer than any other
class of chemotherapeutic agents. Anthracyclines are designed
to utilize natural processes to induce deoxyribonucleic acid (DNA)
damage in targeted cancer cells by interfering with the action of
topoisomerase II, a critical enzyme enabling cell proliferation.
Berubicin treatment of brain cancer patients appeared to
demonstrate positive responses that include one durable complete
response in a Phase 1 human clinical trial conducted by
Reata.
About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is
a biotechnology company specializing in the development of novel
treatments for primary and metastatic brain and central nervous
system tumors. Its lead candidate Berubicin is proposed for
the treatment of glioblastoma, a type of brain cancer currently
considered incurable, as well as for pancreatic and ovarian
cancers, and lymphomas. The Company entered into an
intellectual property (IP) agreement with Houston Pharmaceuticals,
Inc. and a Purchase Agreement with Reata. For more
information, visit www.cnspharma.com.
Forward-Looking Statements
Some of the statements in
this 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 receive
orphan drug designation for Berubicin and to commence Phase II
trials of Berubicin this year. These statements relate to future
events, future expectations, plans and prospects. Although CNS
believes that 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
in our 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 release speak only as
of its date. CNS undertakes no obligation to update any
forward-looking statements contained in this 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.