HOUSTON, July 22, 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 recognizes Glioblastoma (GBM)
Awareness Day.
GBM is a highly aggressive and virtually incurable form of brain
cancer. Every year, roughly 10,000 individuals in the United States are expected to succumb to
glioblastoma. Accounting for more than 60% of all brain
tumors in adults, it is estimated that more than 13,000 Americans
will be diagnosed with GBM in 2020. For the past several decades,
the survival outcomes and mortality rates for patients with GBM
have improved only slightly. Patients diagnosed with GBM currently
have a median survival time of 14-16 months, and a five-year
survival rate of just 6.8%.
CNS Pharmaceuticals is continuing to drive the development of
Berubicin, a novel therapy for the treatment of glioblastoma.
Berubicin is an anthracycline, a class of anticancer agents among
the most powerful chemotherapy drugs and effective against more
types of cancer than any other class of chemotherapeutic agents.
Berubicin has demonstrated the potential to be one of the first
anthracyclines to cross over the blood brain barrier and kill tumor
cells in humans. In a Phase 1 human clinical trial under a prior
developer, 44% of patients treated with Berubicin experienced a
statistically significant improvement in progression-free survival
and one patient experienced a durable complete response.
As part of the Company's efforts to initiate a Phase II trial in
GBM by the end of the year, CNS Pharmaceuticals successfully
engaged USA-based Pharmaceutics
International, Inc., (Pii) and Italian BSP Pharmaceuticals S.p.A.,
(BSP) to produce Berubicin drug product. The Company decided to
implement a dual-track drug product manufacturing strategy to
mitigate COVID-19 related risks, diversify its supply chain, and
reduce the risk that inefficiencies could impact the Company's
clinical timeline. Through contracting both a European and
United States manufacturer, the
Company also provided for localized availability of Berubicin for
the upcoming Phase I Pediatric and Phase II adult studies in
Poland, and the U.S. Phase II
trial. CNS has completed synthesis of Berubicin Active
Pharmaceutical Ingredient (API) and has shipped API to both Pii and
BSP to prepare an injectable form of Berubicin ready for clinical
use. CNS believes these are pivotal steps in allowing the Company
to initiate clinical studies in GBM patients.
"Among brain tumors, GBM remains an unmet need for patients,
with bleak survival outcomes and mortality rates," commented
John Climaco, CEO of CNS
Pharmaceuticals. "We would like to take the time today to recognize
GBM Awareness Day, and draw attention to providing solutions to
this very aggressive form of brain tumor which claims numerous
lives every single year. Treating GBM and driving the clinical
development of Berubicin remains a key priority for CNS
Pharmaceuticals and we are extremely pleased to be making
tremendous progress towards our upcoming trials to help these
patients. We look forward to further investigating Berubicin's
potential to treat this deadly cancer in our upcoming Phase I
Pediatric and Phase II adult studies in Poland and initiating our U.S. Phase II
trial."
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 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
trial with Berubicin in GBM which Reata conducted in 2006. In
this trial, 44% of patients experienced a statistically significant
improvement in progression-free survival. 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.
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.
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SOURCE CNS Pharmaceuticals, Inc.