WPD Pharmaceuticals’ Licensor Receives FDA Fast Track Designation for Berubicin for the Treatment of Recurrent Glioblastoma...
July 12 2021 - 7:30AM
WPD Pharmaceuticals Inc. (CSE: WBIO)(FSE: 8SV1)
(the “
Company” or “
WPD”) a
clinical-stage pharmaceutical company, is pleased to announce that
CNS Pharmaceuticals Inc. (“
CNS”) (NASDAQ:CNSP),
the company that licenses the drug candidate Berubicin to WPD for
29 countries mainly in Europe, announced that the U.S. Food and
Drug Administration (FDA) granted Fast Track Designation for its
lead investigational drug, Berubicin, for the treatment of patients
with recurrent glioblastoma multiforme (GBM). As previously
reported, CNS had also received Orphan Drug Designation from the
FDA for Berubicin for the treatment of patients with recurrent GBM.
Fast Track Designation enables more frequent
interactions with the FDA to expedite the development and review
process for drugs intended to treat serious or life-threatening
conditions and that demonstrate the potential to address unmet
medical need. Receiving Fast Track Designation from the U.S. FDA is
a significant achievement in the advancement of Berubicin for the
treatment of glioblastoma, the most aggressive, deadly and
treatment-resistant type of cancer that forms in the brain. Many
patients have almost no meaningful options and thousands lose the
fight against this cancer every year. With this designation, CNS
now has an accelerated pathway to approval for Berubicin and a
clear opportunity to bring this potentially impactful
investigational therapy more expediently.
CNS recently announced the start of patient
enrollment in its study of Berubicin for the treatment of recurrent
glioblastoma multiforme. WPD would significantly benefit from
advancement of Berubicin as a treatment for GBM as it has the
rights to produce and sell the drug candidate in 29 countries.
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.
WPD Loans
WPD’s subsidiary in Poland, WPD Pharmaceuticals
sp. z.o.o. has arranged to borrow up to $150,000 USD from each of
two companies, each of which are controlled by insiders. The loans
bear interest at 10% per annum and mature on April 2, 2022. The
loans are not convertible to shares. The insider loans are exempt
from the valuation and minority shareholder approval requirements
of MI 61-101 by virtue of the exemptions contain in section 5.5(a)
and 5.7(a) of MI 61-101 in that the fair market value of the
consideration of the notes to be issued to each of the insiders
does not exceed 25% of WPD’s market capitalization.
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 9 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 technologies of the licensor. Such agreements
provide WPD with certain research, development, manufacturing and
sales rights, among other things. The sublicense territory from CNS
Pharmaceuticals and Moleculin Biotech includes about 29 countries
in Europe and Asia, including Russia, depending on the
compound.
On Behalf of the Board
‘Mariusz Olejniczak’
Mariusz Olejniczak CEO, WDP Pharmaceuticals
Contact:
Investor Relations Email:
investors@wpdpharmaceuticals.com Tel: 604-428-7050 Web:
www.wpdpharmaceuticals.com
Investor Relations:
Arrowhead Business and Investment Decisions,
LLC
Thomas Renaud Managing Director 42 Broadway, 17th
Floor New York, NY 10004 Office: +1 212 619-6889
enquire@arrowheadbid.com
Cautionary Statements:
Neither the Canadian Securities Exchange nor the
Investment Industry Regulatory Organization of Canada accepts
responsibility for the adequacy or accuracy of this release.
This press release 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, that WPD would
significantly benefit from advancement of Berubicin as a treatment
for GBM. Forward-looking statements in this press release include
that WPD’s drugs could be developed into novel treatments for
cancer. 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 the drug compounds may not provide the benefits
expected and we may not develop them further; competitors or others
may successfully challenge a granted patent and the patent 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; and we may be unable to obtain regulatory
approval for any drugs we develop. The Company assumes no
obligation to update them except as required by applicable law.
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