Evgen Pharma PLC All approvals received for STAR trial to commence (9767C)
23 October 2020 - 5:00PM
UK Regulatory
TIDMEVG
RNS Number : 9767C
Evgen Pharma PLC
23 October 2020
Evgen Pharma plc
("Evgen" or the "Company")
All approvals received for STAR trial to commence
Evgen Pharma plc (AIM: EVG), a clinical stage drug development
company, is pleased to announce that all necessary regulatory
approvals have now been received for the STAR trial (SFX-01
treatment for Acute Respiratory Infections). Trial recruitment is
expected to commence around the end of the month.
STAR is a Phase II/III trial to investigate whether the
company's lead asset, SFX-01, can reduce the severity, or prevent
the onset of, acute respiratory distress syndrome ("ARDS") in
patients with suspected COVID-19. Patients may therefore be drawn
from both hospital and community settings and may present with C
OVID -19 or other respiratory diseases. It is a randomised,
placebo-controlled trial and is sponsored by the University of
Dundee.
SFX-01 upregulates the Nrf2 pathway which is part of the natural
human defence against inflammatory and oxidative stress, such as
the inflammation that occurs during a severe viral infection.
Preclinical studies have shown that up-regulating the Nrf2 pathway
reduces the severity of ARDS, the progressive lung damage observed
in COVID-19 and pneumonia patients, which can result in the need
for invasive ventilation in an intensive care unit.
The clinical study is being supported by a grant from LifeArc,
as previously announced in June 2020, and is being led by Professor
James Chalmers, British Lung Foundation Professor of Respiratory
Research at the University of Dundee. The results are expected in
2021.
Evgen will supply clinical centres with SFX-01 and a placebo as
its contribution to the trial. No additional financing is required
as the costs of providing SFX-01 for the trial are not
material.
Dr Huw Jones, Evgen CEO, commented: "Receiving full regulatory
approval is a significant step forward for us. We look forward to
the start of recruitment for the trial shortly with our partner. We
hope that the outcome of this trial will lead to an additional
treatment for COVID-19 patients and that SFX-01 could play a big
part in managing the current pandemic."
The information communicated in this announcement is inside
information for the purposes of Article 7 of EU Regulation
596/2014.
Enquiries:
Evgen Pharma plc www.evgen.com via Walbrook
Barry Clare, Chairman
Dr Huw Jones, CEO
Richard Moulson, CFO
finnCap www.finncap.com +44 (0)20 7220 0500
Geoff Nash / Teddy Whiley (Corporate
Finance)
Alice Lane (ECM)
Walbrook PR +44 (0)20 7933 87870 or evgen@walbrookpr.com
+44 (0)7980 541 893 / +44 (0)7876
Paul McManus / Anna Dunphy 741 001
About Evgen Pharma plc
Evgen Pharma is a clinical stage drug development company
developing sulforaphane based medicines for the treatment of
multiple diseases . The Company's core technology is Sulforadex
(R), a method for synthesising and stabilising the naturally
occurring compound sulforaphane and novel proprietary analogues
based on sulforaphane. The lead product, SFX-01, is a patented
composition of synthetic sulforaphane and alpha-cyclodextrin.
Clinical data from the Company's open-label Phase II STEM trial
has shown that SFX-01 can halt the growth of progressing tumours in
patients with oestrogen-positive (ER+) metastatic breast cancer,
and in some cases significantly shrink the tumour, whilst causing
very few side effects.
The Company commenced operations in January 2008 and has its
headquarters at The Colony, Wilmslow, Cheshire, and its registered
office is at the Liverpool Science Park, Liverpool. It joined the
AIM market of the London Stock Exchange in October 2015 and trades
under the ticker symbol EVG.
For further information, please visit: www.evgen.com
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