Revive Therapeutics Announces IRB Approval of US Expanded Access Treatment Program (Compassionate Use) for Bucillamine in COV...
September 16 2020 - 8:00AM
Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV,
USA: RVVTF), a specialty life sciences company focused on the
research and development of therapeutics for medical needs and rare
disorders, is pleased to announce that the Company’s expanded
access protocol (“EAP”) for compassionate use of Bucillamine in the
treatment of COVID-19 received approval from the independent
Institutional Review Board ("IRB"). The EAP for compassionate use
is a multi-center, open label study of Bucillamine in hospitalized
patients with severe COVID-19 and is being done to complement the
Company’s Phase 3 COVID-19 study in the U.S. Revive expects
to have patients enrolled in the United States this month.
“With the IRB approval
of the expanded access protocol by Advarra, a premier IRB services
company in North America, hospitalized patients with severe
COVID-19 may access Bucillamine under the FDA compassionate use
program under medical supervision by their physician,” said Michael
Frank, Revive’s Chief Executive Officer. “The EAP serves as an
option for patients that are not eligible for inclusion criteria in
our Phase 3 clinical study in COVID-19 and the resulting data from
the EAP will be valuable in supporting our clinical development of
Bucillamine.”
The EAP for
compassionate use provides physicians with access to Bucillamine
under Revive’s existing Investigational New Drug (“IND”)
application for COVID-19. According to the FDA, expanded
access is a potential pathway for a patient with an immediately
life-threatening condition or serious disease or condition to gain
access to an investigational medical product for treatment outside
of clinical trials when no comparable or satisfactory alternative
therapy options are available.
About the Expanded
Access Study
The expanded access
study is titled, “Multi-Center, Open-Label, Expanded Access Study
of Bucillamine in Hospitalized Patients with Severe COVID-19
(EA-ARISE)”. Patients will receive
Bucillamine 200 mg orally, 3 times a day (TID), for up to 14 days.
The objective is to monitor the safety and efficacy of Bucillamine
(600 mg/day) and any clinical symptoms when administered up to 14
days in hospitalized patients with severe COVID-19. Following
completion of the treatment course, follow up safety assessments
will be performed by a study nurse 14 and 42 days following the end
of treatment.
The Company is not
making any express or implied claims that its product has the
ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this
time.
Scientific Rationale
of Bucillamine for COVID-19
Preclinical and
clinical studies have demonstrated that reactive oxygen species
contribute to the destruction and programmed cell death of
pulmonary epithelial cells.1 N-acetyl-cysteine (NAC) has been shown
to significantly attenuate clinical symptoms in respiratory viral
infections in animals and humans, primarily via donation of thiols
to increase antioxidant activity of cellular glutathione2,3,4,5.
Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) has a
well-known safety profile and is prescribed in the treatment of
rheumatoid arthritis in Japan and South Korea for over 30 years.
Bucillamine, a cysteine derivative with two thiol groups, has been
shown to be 16 times more potent as a thiol donor in vivo than NAC
6. The drug is non-toxic with high cellular permeability. The basis
of the clinical study will analyze if Bucillamine has the
potential, via increasing glutathione activity and other
anti-inflammatory activity, to lessen the destructive consequences
of SARS-CoV-2 infection in the lungs and attenuate the clinical
course of COVID-19.
About Revive Therapeutics
Ltd.
Revive is a life sciences company focused on the
research and development of therapeutics for infectious diseases
and rare disorders, and it is prioritizing drug development efforts
to take advantage of several regulatory incentives awarded by the
FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare
Pediatric Disease designations. Currently, the Company is exploring
the use of Bucillamine for the potential treatment of infectious
diseases, with an initial focus on severe influenza and COVID-19.
With its recent acquisition of Psilocin Pharma Corp., Revive is
advancing the development of Psilocybin-based therapeutics in
various diseases and disorders. Revive’s cannabinoid pharmaceutical
portfolio focuses on rare inflammatory diseases and the company was
granted FDA orphan drug status designation for the use of
Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and
to treat ischemia and reperfusion injury from organ
transplantation. For more information, visit
www.ReviveThera.com.
For more information, please contact:
Michael Frank Chief Executive Officer Revive Therapeutics Ltd.
Tel: 1 888 901 0036 Email: mfrank@revivethera.com
Website: www.revivethera.com Neither the Canadian
Securities Exchange nor its Regulation Services Provider have
reviewed or accept responsibility for the adequacy or accuracy of
this release.
Cautionary Statement
This press release contains ‘forward-looking
information’ within the meaning of applicable Canadian securities
legislation. These statements relate to future events or future
performance. The use of any of the words “could”, “intend”,
“expect”, “believe”, “will”, “projected”, “estimated” and similar
expressions and statements relating to matters that are not
historical facts are intended to identify forward-looking
information and are based on Revive’s current belief or assumptions
as to the outcome and timing of such future events. Forward looking
information in this press release includes information with respect
to the Offering, including the intended use of proceeds.
Forward-looking information is based on reasonable assumptions that
have been made by Revive at the date of the information and is
subject to known and unknown risks, uncertainties, and other
factors that may cause actual results or events to differ
materially from those anticipated in the forward-looking
information. Given these risks, uncertainties and assumptions, you
should not unduly rely on these forward-looking statements. The
forward-looking information contained in this press release is made
as of the date hereof, and Revive is not obligated to update or
revise any forward-looking information, whether as a result of new
information, future events or otherwise, except as required by
applicable securities laws. The foregoing statements expressly
qualify any forward-looking information contained herein. Reference
is made to the risk factors disclosed under the heading “Risk
Factors” in the Company’s annual MD&A for the fiscal year ended
June 30, 2019, which has been filed on SEDAR and is available under
the Company’s profile at www.sedar.com.
References
1. S Ye et al,
Inhibition of Reactive Oxygen Species Production Ameliorates
Inflammation Induced by Influenza A Viruses via Upregulation of
SOCS1 and SOCS3., American Society for Microbiology. 2015
Mar;89(5):2672-2683).
2. L. Carati et al,
Attenuation of influenza-like symptomatology and improvement of
cell-mediated immunity with long-term N-acetylcysteine treatment.,
Eur Respir J. 1997 Jul;10(7):1535-41).
3. M Mata et al,
N-acetyl-L-cysteine (NAC) inhibit mucin synthesis and
pro-inflammatory mediators in alveolar type II epithelial cells
infected with influenza virus A and B and with respiratory
syncytial virus (RSV)., Biochem Pharmacol. 2011
Sep;82(5):548-55.
4. D Ungheri et al,
Protective effect of n-acetylcysteine in a model of influenza
infection in mice., Int J Immunopathol Pharmacol. 2000
Sep-Dec;13(3):123-128.
5. RH Zhang et al,
N-acetyl-l-cystine (NAC) protects against H9N2 swine influenza
virus-induced acute lung injury., Int Immunopharmacol. 2014
Sep;22(1):1-8).
6. LD Horwitz, Bucillamine: a potent thiol donor
with multiple clinical applications, Cardiovasc Drug
Rev. 2003 Summer;21(2):77-90).
Revive Therapeutics (CSE:RVV)
Historical Stock Chart
From Mar 2024 to Apr 2024
Revive Therapeutics (CSE:RVV)
Historical Stock Chart
From Apr 2023 to Apr 2024