Evgen Pharma PLC Update on patient recruitment (3128P)
February 17 2021 - 2:00AM
UK Regulatory
TIDMEVG
RNS Number : 3128P
Evgen Pharma PLC
17 February 2021
Evgen Pharma plc
("Evgen" or the "Company")
Update on patient recruitment
STAR COVID-19 trial exceeds 100 patients
Evgen Pharma plc (AIM: EVG), a clinical stage drug development
company, announces that as of 16 February, a total of 102 patients
had been recruited and randomised to the STAR trial ("SFX-01
Treatment for Acute Respiratory infections").
This Phase II/III trial is a randomised, placebo-controlled
trial, sponsored by the University of Dundee and funded by the UK
charity LifeArc. It is investigating 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 be included in the study if they
are infected with SARS-CoV-2 or another respiratory infections
causing community-acquired pneumonia.
The trial design includes an assessment of safety and futility
by a Data Safety and Monitoring Board ("DSMB") who will review
unblinded data on the first 100 patients treated. In addition to
the DSMB safety and futility assessment, Dundee University ("the
Sponsor") has decided to review the top-level unblinded data in a
preliminary assessment of possible efficacy. This may lead to
adjustments to the design of the trial for remaining patients,
including in patient numbers, and possibly early termination for
either safety, futility or alternatively, strong efficacy. It is
expected that this initial data will be available during the second
quarter of calendar 2021.
The Sponsor has also requested that the DSMB review data from
the first 60 patients solely for safety and this process will be
starting shortly. The outcome of this is expected to be available
in early Q2 2021.
Completion of recruitment to the STAR trial is anticipated at
the end of 2021/Q1 2022, assuming there are no substantial changes
in the total patients to be recruited.
Dr Huw Jones, CEO of Evgen, commented : "We are pleased with the
recruitment progress in this trial and would again like to thank
Professor James Chalmers and his colleagues at Dundee for their
considerable efforts in a very challenging clinical environment.
Randomising over 100 patients is an important milestone in this
trial and takes us a step closer to receiving the initial data from
the study. 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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