WPD Pharmaceuticals Engages Worldwide Clinical Trials as CRO for Phase 2 Berubicin Trials
09 September 2020 - 9:30PM
WPD Pharmaceuticals Inc. (“WPD” or the “Company”) (CSE:
WBIO) (FSE: 8SV1), a clinical stage pharmaceutical
company, is pleased to announce that is has engaged world-renowned
Contract Research Organization (“
CRO”), Worldwide
Clinical Trials (“
WCT”) to coordinate and
supervise Phase 1 and 2 clinical trials on its Berubicin drug
candidate. Berubicin is a new drug and one of the first
anthracyclines proven to cross the blood-brain barrier to reach
brain tumors. The discovery and further development of Berubicin
can potentially extend the clinical use of anthracyclines to brain
tumors, specifically Glioblastoma, an aggressive type of cancer
that can occur in the brain or spinal cord .WCT is a global CRO
providing full-service drug development services to the
pharmaceutical and biotechnology industries from Early Phase and
Bioanalytical Sciences through Phase II and III trials to
peri-approval studies. WCT offers clients expertise in
neuroscience, cardiovascular, inflammation, rare disease, oncology
and other therapeutic areas. They manage clinical trials across
nearly 60 countries in North America, Latin America, Europe, Asia
Pacific and Middle East.
WCT will provide research services,
implementation of start-up activities, organization and development
for clinical trials being conducted by WPD in adult and pediatric
populations with Glioblastoma, according to international standards
of good clinical practice (ICH GCP) and other applicable regulatory
requirements. These requirements include safety management,
pharmaco-vigilancem and data management. WCT will also support
WPD’s application for orphan drug designation, which if successful,
has filing fee savings and other benefits.
60% of the program budget will be refunded by a
grant already awarded to WPD by The National Center for Research
and Development based in Poland under the European Union’s Smart
Growth Operational Program.
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 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 for most
compounds 30 countries in Europe and Asia, including Russia.
On Behalf of the Board
‘Mariusz Olejniczak’Mariusz Olejniczak CEO, WPD
Pharmaceuticals
Contact
Investor Relations Email: investors@wpdpharmaceuticals.comTel:
604-428-7050 Web: www.wpdpharmaceuticals.com 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 can
develop effective drugs against cancer and possibly viruses; and
that Phase II clinical trials of Berubicin will be undertaken by
WCT; that we will be reimbursed 60% of the Phase II trials costs;
that Berubicin may be designated as an orphan drug; and that
Berubicin could be effective in treating Glioblastoma. Factors
which may prevent the forward looking statement from being realized
include that our supply of compounds for testing may not be
sufficient for our needs; lack or funds, permits, subcontractors or
other factors may delay our plans; competitors or others may
successfully challenge a granted patent and the patent could be
rendered void; we may be unable to raise sufficient funding for our
research; we may be unable to expend sufficient funds on research
to keep our sublicense rights; our grant and other applications may
not be successful or if successful, 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; and competitors may develop better or cheaper drugs; our
plans may be delayed; we may not be able to get commercial
quantities of our drugs made; and we may be unable to obtain
regulatory approval for any drugs we develop. 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 press release and the
Company assumes no obligation to update them except as required by
applicable law.
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