Evgen Pharma PLC Patient recruitment update in STAR-COVID 19 trial (0902M)
January 19 2021 - 1:00AM
UK Regulatory
TIDMEVG
RNS Number : 0902M
Evgen Pharma PLC
19 January 2021
Evgen Pharma plc
("Evgen" or the "Company")
Update on patient recruitment in STAR-COVID 19 trial
Evgen Pharma plc (AIM: EVG), a clinical stage drug development
company, announces that as of 18 January, a total of 56 patients
had been recruited and randomised to the STAR trial ("SFX-01
treatment for Acute Respiratory Infections").
This Phase II/III randomised, placebo-controlled trial is
sponsored by the University of Dundee and funded by the UK charity
Life Arc. It will 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
community-acquired pneumonia from any infective agent and who have
been or are being tested for suspected COVID-19. Patients may
therefore present with COVID-19 or other respiratory diseases.
The trial design includes an assessment of safety and futility
by a Data Safety and Monitoring Board who will review unblinded
data on the first 100 patients treated. An announcement will be
made when this point has been reached.
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
has the potential to reduce 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.
Dr Huw Jones, CEO of Evgen, commented: "We are pleased with the
recruitment progress in this trial and would like to thank
Professor James Chalmers and his colleagues at Dundee for their
considerable efforts in a difficult clinical environment. We are
greatly encouraged by recent academic papers which reinforce
previous preclinical data showing the potential benefit to ARDS
patients of up-regulating Nrf2 and hope that SFX-01 may be a
valuable addition to the array of treatments that these seriously
ill patients can receive. We look forward to further updating the
market as we progress through this important trial."
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 878 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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