WPD Pharmaceuticals Inc. (CSE: WBIO)(FSE: 8SV1)
(the “
Company” or “
WPD”) a
clinical-stage pharmaceutical company, today provided an update on
its Berubicin drug candidate clinical development program for the
treatment of glioblastoma multiforme (GBM).
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.
Phase II Adult Glioblastoma Clinical
Trial
Berubicin’s Phase I clinical trial in adults,
the first time it was tested in humans, yielded promising results
with 44% of the patients with glioblastoma multiforme (GBM) showing
a clinical response of stable disease or better based on limited
clinical data. This response rate rises to 49% in Avastin-naive
patients. Importantly, Berubicin has shown evidence of improved
overall survival in a patient population that currently has a
dismal median survival rate of only 14.6 months from diagnosis.
WPD expects final approval from the Office for
Registration of Medicinal Products, Medical Devices and Biocidal
Products shortly and anticipates starting a Phase II Trial in the
second half of 2021. Based on the promising Phase I results, WPD
plans to commence a multicenter, open-label, Phase Ib/II efficacy,
and safety study of Berubicin utilizing a Simon's 2-stage design to
confirm the efficacy (or futility) of a single arm of Berubicin
treatment, administered at the recommended Phase II dose (RP2D)
identified in the Phase I study (7.5 mg/m2 Berubicin HCl), on the
endpoint of Overall Response Rate in up to approximately 61
patients with GBM. The trials will include an interim analysis of
the first 18 patients in the first half of 2022 for efficacy and
safety as well as an extensive pharmacokinetic profile for these
patients.
More details about study could be found on
ClinicalTrials.gov under number NCT04915404. After approval of the
study by the Regulatory Agency clinical sites data will also be
available.
https://www.clinicaltrials.gov/ct2/show/NCT04915404?term=wpd&draw=2&rank=3
Phase I Pediatric Clinical Trial for
Malignant Gliomas
WPD is planning the Phase I clinical trial for
malignant gliomas at two clinical sites in Poland. The study
includes a multicenter, open-label, dose escalation Phase I study
of intravenous Berubicin in pediatric patients. The purpose of this
first-in-pediatrics study is to examine the safety, tolerability,
and pharmacokinetics of Berubicin and to estimate its MTD and/or
RP2D when administered to pediatric patients with progressive,
refractory, or recurrent HGG who have completed at least 1 standard
line of therapy. This study will also make a preliminary assessment
of the antitumor activity of Berubicin in this patient population
in up to approximately 35 patients. This Phase I trial of Berubicin
represents the first ever investigation of Berubicin in pediatric
brain tumors.
WPD has already received Ethical Committee
approval for Phase I clinical trial and has submitted its request
for approval from the Office for Registration of Medicinal
Products, Medical Devices and Biocidal Products. Information on
approval and study number in European clinical trials database will
be provided within 60 days. WPD expects to commence the Phase I
clinical trial in Q3/Q4 2021.
CNS Commences Patient Enrollment in
Potentially Pivotal Study of Berubicin
CNS Pharmaceuticals (NASDAQ:CNSP)
(“CNS”), the company that sublicenses the compound
Berubicin to WPD for 30 countries mainly in Europe and Asia,
announced open enrollment in the United States for its clinical
study evaluating the efficacy and safety of Berubicin in the
treatment of recurrent GBM.
CNS’s potentially pivotal trial is an adaptive,
multicenter, open-label, randomized and controlled study in adult
patients with recurrent glioblastoma multiforme (WHO Grade IV)
after failure of standard first-line therapy. The primary endpoint
of the study is Overall Survival. Overall Survival is a rigorous
endpoint that the U.S. Food and Drug Administration (FDA) has
recognized as a basis for approval of oncology drugs when a
statistically significant improvement can be shown relative to a
randomized control arm. Results from the trial will compare
Berubicin to the current standard of care, with a 2 to 1
randomization of patients to receive either Berubicin or
Lomustine.
Mariusz Olejniczak, CEO of WPD
commented, “I am very pleased and excited about the development we
have made on Berubicin both in the United States and in Europe. Our
combined WPD and CNS clinical studies are going to start to recruit
patients shortly which is an exciting step in the development
programs. To ensure patients are informed and updated on possible
sites, we will use clinicaltrials.gov as the primary source of
information. We are hopeful that this is the first step in changing
the landscape of glioma treatment with products in our pipeline and
trough collaboration with different companies, scientific
institutions, and our license partners. I would like to take an
opportunity to thank both the WPD and CNS teams and our vendors and
partners including WWCT and IAG for the hard work during pandemic
months.”
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 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 OlejniczakCEO, WDP Pharmaceuticals
Contact:
Investor RelationsEmail:
investors@wpdpharmaceuticals.comTel: 604-428-7050Web:
www.wpdpharmaceuticals.com
Investor Relations:
Arrowhead Business and Investment Decisions, LLC
Thomas RenaudManaging Director42 Broadway, 17th FloorNew
York, NY 10004Office: +1 212
619-6889enquire@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. Forward-looking
statements in this press release include that WPD’s drugs could be
developed into novel treatments for cancer, and that we anticipate
starting the Phase II Trial of Berubicin in the second half of 2021
and will include an interim analysis of the first 18 patients in
the first half of 2022; and we expect to commence the Phase I
pediatric clinical trial in Q3/Q4 2021. These forward-looking
statements reflect the Company’s current expectations based on
information currently available to management and are subject to
several 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
technology may not provide the benefits expected and we may not
engage 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; our expected timing of trials may be delayed; 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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