WPD and CNS Pharmaceuticals Announce Positive Opinion of the Polish Central Ethics Committee for the WPD-201 Study and Centra...
February 18 2021 - 9:05AM
WPD Pharmaceuticals (CSE:WBIO) (8SV1.F) ("WPD")
and
CNS Pharmaceuticals, Inc. (NASDAQ: CNSP)
("CNS" or the "Company"), biopharmaceutical companies specializing
in the development of novel treatments for primary and metastatic
cancers of the brain and central nervous system, today announced
that WPD Pharmaceuticals received a positive opinion of the Lower
Silesian Medical Chamber Ethics Committee in Wrocław, Poland for
its planned upcoming Berubicin clinical trial in adults with
Glioblastoma Multiforme (GBM) under the WPD-201 Clinical Trial
Protocol. CNS Pharmaceuticals has received study level Central IRB
Approval from the Central IRB for the CNS-201 Clinical Trial
Protocol.
Berubicin is the Company’s novel anthracycline
candidate for the treatment of a number of serious oncology
indications, currently in development for the treatment of GBM. CNS
entered into a sublicense agreement with WPD in November 2019,
which provided WPD the commercial rights in select territories in
Europe and Asia to Berubicin.
Mariusz Olejniczak, CEO of WPD
comments, “This is an important step for WPD from both a project
and sublicense agreement point of view. After receiving the
positive opinion from the Central Ethics Committee, we are planning
to submit our application to the Office for Registration of
Medicinal Products, Medical Devices and Biocidal Products, which is
the Polish equivalent of the FDA. We hope to receive approval
within three months from submission, dependent on if we receive any
questions or requests from the President of the Office. We are
planning for our sites to start recruiting patients soon after
approval is received. Information about our sites will be published
both on clinicaltrials.gov and in the European database. During the
review process, we will start preparing submissions to Ethic
Committee and Competent Authority (equivalent of FDA) in one
country outside of Poland.”
“We are pleased for WPD to achieve this key
milestone and are encouraged by their continued execution in
furthering the development of Berubicin,” commented John
Climaco, CEO of CNS Pharmaceuticals. “Importantly, we
believe WPD’s Ethics Committee approval of the WPD-201 Clinical
Trial Protocol coupled with our recent IND approval and Central IRB
Study Level approval, position us one step closer to
collaboratively initiating three clinical trials for Berubicin
during 2021. We look forward to continuing our trial preparations,
as well as WPD’s planned submissions to the Polish Competent
Authority.”
Following the sublicense agreement, WPD was
subsequently awarded a reimbursement grant for further development
of Berubicin that was valued at $6 million upon the date of the
grant from the Polish National Center for Research and Development
under Smart Growth Operational Program 2014-2020 co-financed by the
European Union. WPD plans to initiate both a multicenter Berubicin
Phase 2 adult GBM trial in the first half of 2021 and a multicenter
pediatric malignant glioma Phase 1 clinical trial in 2021. Roughly
60% of the program budget is expected to be funded by the
reimbursement grant.
CNS Pharmaceuticals has received approval to
proceed with their previously submitted Investigational New Drug
(IND), from the U.S. Food and Drug Administration (FDA) for
Berubicin in the treatment of GBM. The Company plans to initiate
its Phase 2 trial evaluating the efficacy and safety of Berubicin
in the treatment of adults with GBM who have failed first-line
therapy in the first quarter of 2021. The Company has also received
Central IRB study level approval for the U.S. portion of the adult
GBM study.
About Berubicin
Berubicin is an anthracycline, a class of drugs
among the most powerful chemotherapy drugs and effective against
more types of cancer than any other class of chemotherapeutic
agents. Anthracyclines are designed to damage the DNA of targeted
cancer cells by interfering with the action of the topoisomerase
II, a critical enzyme enabling cell proliferation. Berubicin was
developed at the MD Anderson Cancer Center (MDACC), the world's
largest cancer research facility. Berubicin appeared to demonstrate
one Durable Complete Response in a Phase I human clinical trial
conducted by a prior developer.
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 the overall response rate of stable disease or better was
44%. 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.
About WPD Pharmaceuticals
WPD is a biotechnology research and development
company with a focus on oncology and virology, namely research and
development of medicinal products involving biological compounds
and small molecules. WPD has licensed in certain countries 10 novel
drug candidates with 4 that are in clinical development stage.
These drug candidates were researched at medical institutions, and
WPD currently has ongoing collaborations with Wake Forest
University and leading hospitals and academic centers in
Poland.
WPD has entered into license agreements with
Wake Forest University Health Sciences and sublicense agreements
with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc.,
respectively, each of which grant WPD an exclusive, royalty-bearing
sublicense to certain compounds for about 30 countries, mostly
in Europe. Such agreements provide WPD with certain research,
development, manufacturing and sales rights and obligations,
among other things.
For more information, please visit wpdpharmaceuticals.com.
On Behalf of the Board
‘Mariusz Olejniczak’ Mariusz OlejniczakCEO, WPD
Pharmaceuticals
Contact:
Investor RelationsEmail: investors@wpdpharmaceuticals.comTel:
604-428-7050Web: www.wpdpharmaceuticals.com
Forward Looking Statements
This document contains forward-looking
statements. Forward-looking statements are statements that
contemplate activities, events or developments that the Company
anticipates will or may occur in the future. Forward-looking
statements in this press release include timing for clinical trials
for our drug candidates; that a large portion of our program budget
will be refunded by research and other grants and that WPD’s drugs
could be developed into novel treatments for cancer and other
diseases. These forward-looking statements reflect the Company’s
current expectations based on information currently available to
management and are subject to a number of risks and uncertainties
that may cause outcomes to differ materially from those projected.
Factors which may prevent the forward looking statement from being
realized is that competitors or others may successfully challenge
granted patents and the patents could be rendered void; that we are
unable to raise sufficient funding for our research; that we may
not meet the requirements to receive the grants awarded; that our
drugs don’t provide positive treatment, or if they do, the side
effects are damaging; competitors may develop better or cheaper
drugs; we may be unable to obtain regulatory approval for any drugs
we develop; and we may otherwise be unable to carry out our
business plans. Readers should refer to the risk disclosure
included from time-to-time in the documents the Company files on
SEDAR, available at www.sedar.com. Although the Company believes
that the assumptions inherent in these forward-looking statements
are reasonable, they are not guarantees of future performance and,
accordingly, they should not be relied upon and there can be no
assurance that any of them will prove to be accurate. Finally,
these forward-looking statements are made as of the date of this
document and the Company assumes no obligation to update them
except as required by applicable law.
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