Resverlogix In Active Discussions With The Kingdom of Morocco’s Ministry of Health For The Launch Of COVID-19 Clinical Studies With First-In-Class Drug Apabetalone
2021年11月1日 - 9:30PM
Resverlogix In Active Discussions With The Kingdom of Morocco’s
Ministry of Health For The Launch Of COVID-19 Clinical Studies With
First-In-Class Drug Apabetalone
Resverlogix Corp. (“Resverlogix” or the “Company”) (TSX: RVX), a
world leader in epigenetics or gene regulation, is pleased to
announce today that it is in active discussions with the
Kingdom of Morocco’s Ministry of Health for possible Phase 2
COVID-19 clinical studies within their hospitals using
first-in-class drug – apabetalone.
“We are pleased to collaborate with the Kingdom of Morocco’s
Ministry of Health under the leadership of Professor Bouchra
Meddah, Director of Medicines and Pharmacy, for the possible launch
of COVID-19 clinical studies with our novel epigenetic drug
apabetalone. It is imperative to clear hospital beds of COVID-19
patients to allow urgent surgeries and other necessities to take
place, which will contribute to reopening and strengthening the
economy in the Kingdom of Morocco,” said Donald J. McCaffrey,
President & CEO of Resverlogix.
“The Kingdom of Morocco’s Ministry of Health is pleased to be
collaborating with Resverlogix on this important global initiative
that has tragically impacted so many people worldwide. Our team was
very impressed by the publications from Cell Journal, Nature
report, along with Health Canada and FDA approvals for COVID-19
clinical trials. Our Ministry has also recognized the FDA’s
granting to Resverlogix the coveted Breakthrough Therapy
Designation for apabetalone in a cardiovascular indication,” said
Professor Bouchra Meddah, Director of Medicines and Pharmacy –
Ministry of Health in the Kingdom of Morocco.
Following Health Canada’s approval for Resverlogix’s COVID-19
clinical trials, it has been actively working with hospitals and
ministries to commence COVID-19 trials globally. On October 12th,
2021, Resverlogix received ethics committee approval for COVID-19
clinical trials in Western Canadian sites. Additionally, a Phase 3
COVID-19 trial in the US is anticipated to commence in coming
months based on final protocol approval.
Phase 2 Trial Overview– Canada/Brazil
Study participants will be made up of patients hospitalized with
confirmed COVID-19 cases. Participants will either receive twice
daily doses of apabetalone for up to 4 weeks alongside standard of
care, compared to standard of care alone. The primary outcome
measure of the study will be change in the World Health
Organization (WHO) Ordinal Scale for Clinical Improvement. A
total of 100 patients are expected to be enrolled at multiple sites
in Canada and Brazil. The full study protocol can be found
on clinicaltrials.gov.
About Apabetalone
Apabetalone (RVX-208), is a first-in-class, epigenetic small
molecule, or gene regulating, therapeutic candidate. It is a
selective BET (bromodomain
and extra-terminal)
inhibitor, which works in preventing disease by turning genes on
and/or off through regulation of gene expression. The
prevalence of BET proteins in the human body allows
apabetalone, through its unique mechanism of action, to
simultaneously target multiple disease-causing biological processes
while maintaining a well described safety profile – leading to a
new way to treat chronic disease.
Cardiology:
In February 2020, apabetalone became the first therapy of its
kind to receive Breakthrough Therapy Designation by the US Food and
Drug Administration (FDA) – for a major cardiovascular indication –
following the ground-breaking findings from the BETonMACE Phase
Three study. Data from BETonMACE showed apabetalone can potentially
prevent major adverse cardiac events among high-risk cardiovascular
disease patients who also have type 2 diabetes mellitus.
Covid-19:
On March 23, 2020, Resverlogix launched its COVID-19
program, enlisting world-renowned collaborators. Studies
demonstrate that apabetalone has the potential to act against
COVID-19 with a unique dual-mechanism: the first pillar of
apabetalone’s dual-mechanism is preventing viruses from entering
the cells and replicating; the second pillar is averting runaway
inflammatory reactions that can cause severe and lasting organ
damage. A Phase Two clinical trial is evaluating
apabetalone in combination with standard of care for patients
hospitalized with COVID-19. Apabetalone treatment could potentially
reduce the severity and duration of COVID-19. Apabetalone’s unique
dual-mechanism also means that it is likely to show efficacy
against COVID-19 variants and may even help fight other related
viruses.
Apabetalone is the only drug of its class with a
well-established safety record in human clinical trials, with well
over 4200 patient-years on drug across 10 clinical trials.
About Resverlogix
Founded in 2001, Resverlogix is a Calgary based late-stage
biotechnology company and the world leader in epigenetics, or gene
regulation, with the goal of developing first-in-class therapies
for the benefit of patients with chronic disease.
Resverlogix is commercializing a new class of epigenetic
therapies designed to regulate gene expression, turning
disease-associated genes “on” or “off”. We aim to improve patients’
lives by restoring biological functions – altered by serious
illnesses such as cardiovascular disease – back to a healthier
state.
The Company’s clinical program is focused on evaluating the lead
epigenetic candidate apabetalone for the treatment of
cardiovascular disease and associated comorbidities, and
COVID-19.
Resverlogix common shares trade on the Toronto Stock Exchange
(TSX:RVX).
Follow us: Twitter: @Resverlogix_RVX.
LinkedIn: https://www.linkedin.com/company/resverlogix-corp-/
Forward Looking Statements:
This news release may contain certain forward-looking
information as defined under applicable Canadian securities
legislation, that are not based on historical fact, including
without limitation statements containing the words "believes",
"anticipates", "plans", "intends", "will", "should", "expects",
"continue", "estimate", "forecasts" and other similar expressions.
In particular, this news release includes forward looking
information related to the Company’s discussions with the Kingdom
of Morocco’s Ministry of Health, the Company’s clinical trials and
the potential role of Apabetalone in the treatment of patients with
COVID-19 (and potentially other viruses), cardiovascular disease
and associated comorbidities and other chronic diseases. Our actual
results, events or developments could be materially different from
those expressed or implied by these forward-looking statements. We
can give no assurance that any of the events or expectations will
occur or be realized. By their nature, forward-looking statements
are subject to numerous assumptions and risk factors including
those discussed in our Annual Information Form and most recent
MD&A which are incorporated herein by reference and are
available through SEDAR at www.sedar.com. The forward-looking
statements contained in this news release are expressly qualified
by this cautionary statement and are made as of the date hereof.
The Company disclaims any intention and has no obligation or
responsibility, except as required by law, to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
For further information please contact:
Investor
RelationsEmail: ir@resverlogix.com Phone:
403-254-9252www.resverlogix.com
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/37e766e7-6988-45b9-b572-a129fcd3b126
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