WPD Pharmaceuticals Announces Berubicin Supply Agreement for the Upcoming Clinical Trials
February 24 2021 - 7:30AM
WPD Pharmaceuticals (CSE:WBIO) (8SV1.F) ("WPD" or the “Company”)
today announced that it has signed an agreement with CNS
Pharmaceuticals, Inc. (NASDAQ:CNSP) (“CNS”) to obtain
Investigational Medicinal Product (“IMP”) for use in the planned
clinical trials of Berubicin. WPD will purchase half of the batch
previously manufactured for CNS by BSP Pharmaceuticals for the
WPD-201 and WPD-201P studies which are planned to begin in the
first half of 2021. This IMP will be QP certified by Clinigen
Clinical Supplies Management on behalf of WPD under European
current Good Manufacture Practice (“cGMP”) requirements.
Berubicin is a novel anthracycline candidate for
the treatment of a number of serious oncology indications including
Glioblastoma Multiforme (GBM). WPD sublicensed Berubicin from CNS
in November 2019, which provided WPD with the commercial rights to
Berubicin in select territories primarily in eastern Europe and
Asia.
Mariusz Olejniczak, CEO of WPD
comments, “This agreement will allow us to submit a complete
application to the Office for Registration of Medicinal Products,
Medical Devices and Biocidal Products, which is the Polish
equivalent of the FDA, to initiate the studies without any delay.
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.”
Shortly after the sublicense agreement, WPD was
awarded a reimbursement grant for further development of Berubicin
valued at $6 million 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 trial in adult GBM in the first half
of 2021 and a multicenter pediatric malignant glioma Phase 1
clinical trial in 2021.
CNS Pharmaceuticals has received Investigational
New Drug (IND) approval from the U.S. Food and Drug Administration
(FDA) to proceed with their planned randomized and controlled Phase
2 trial of Berubicin in the treatment of adults with GBM who have
failed first-line therapy, which is expected to commence in the
first quarter of 2021. The FDA has also designated Berubicin an
Orphan Drug. CNS has received Central IRB study-level approval for
its GBM study.
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
Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar
Priebe, Professor of Medicinal Chemistry at The University of Texas
MD Anderson Cancer Center.
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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