WPD Pharmaceutical’s Annamycin Drug Approved for Accelerated European Clinical Trial
29 Avril 2020 - 9:05AM
WPD Pharmaceuticals Inc. (CSE: WBIO) (FSE: 8SV1)
(the
“Company” or
“WPD”) a
clinical stage pharmaceutical company is pleased to announce that
through its license partner, Moleculin Biotech, Inc. (NASDAQ: MBRX)
("
Moleculin"), it has been authorized by the
Office for Registration of Medicinal Products, Medical Devices and
Biocidal Products, known as URPL, to accelerate the Phase 1 dose
escalation portion of its clinical trial of Annamycin for the
treatment of acute myeloid leukemia (“
AML”).
The URPL has allowed an amendment to the
Annamycin clinical trial protocol, which among other things,
includes an increase in the dose escalation increment between
cohorts from 30 mg/m2 to 60 mg/m2. The clinical trial is currently
recruiting suitable patients for the 240 mg/m2 cohort, so this
amendment allows the next cohort to increase to 300 mg/m2, assuming
all requirements for safety are met with the 240 mg/m2 cohort.
Mariusz Olejniczak, CEO of WPD
commented, “As Annamycin continues to advance, and studies so far
have demonstrated the absence of any cardiotoxicity, we believe the
trial can and should move more aggressively to establish the
maximum tolerated dose, or MTD. The URPL authorization now sets the
stage to accelerate the dose escalation process. Even though we’ve
seen promising activity from Annamycin, the dosing levels may be
still sub-therapeutic. Based on prior clinical experience with
Annamycin, the 300 mg/m2 dosing level will be the first opportunity
to test Annamycin at what we expect will be therapeutic
levels.”
About WPD Pharmaceuticals
WPD is a biotechnology research and development
company with a focus on oncology, namely research and development
of medicinal products involving biological compounds and small
molecules. WPD has 10 novel drug candidates with 4 that are in
clinical development stage. These drug candidates were researched
at institutions including the Mayo Clinic and Emory University, 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 31 countries in
Europe and Asia, including Russia.
On Behalf of the Board
‘Mariusz Olejniczak’
Mariusz OlejniczakCEO, WPD Pharmaceuticals
Contact:
Investor RelationsEmail:
investors@wpdpharmaceuticals.comTel: 604-428-7050Web:
www.wpdpharmaceuticals.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 can
develop effective drugs, that some of its drug candidates may be
fast tracked with orphan drug designation; and that we will receive
partial reimbursement for certain of its research. Factors which
may prevent the forward looking statement from being realized
include that competitors or others may successfully challenge a
granted patent and the patent could be rendered void; that results
obtained in limited trials may not be able to be duplicated in the
general population; that we are unable to raise sufficient funding
for our research; that we may not meet the requirements to receive
the grants awarded; that ODD status is rejected by the FDA; that
the EU changes the terms of the grants; 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. 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.
WPD Pharmaceuticals (CSE:WBIO)
Graphique Historique de l'Action
De Déc 2024 à Jan 2025
WPD Pharmaceuticals (CSE:WBIO)
Graphique Historique de l'Action
De Jan 2024 à Jan 2025