Evgen Pharma PLC Update on Data Safety Review - STAR COVID-19 trial (8634R)
11 March 2021 - 6:00PM
UK Regulatory
TIDMEVG
RNS Number : 8634R
Evgen Pharma PLC
11 March 2021
Evgen Pharma plc
("Evgen" or the "Company")
Update on Data Safety Review for STAR COVID-19 trial
Review of Patient Safety and Data Quality confirms no concerns
with trial
Evgen Pharma plc (AIM: EVG), a clinical stage drug development
company, announces that after a review of the first 60 patients
enrolled, the Data Safety Monitoring Committee ("DMC") for the STAR
COVID-19 ("SFX-01 Treatment for Acute Respiratory infections")
trial has concluded that there are no concerns regarding patient
safety or data quality that would prevent continuation of the
trial.
The Phase II/III trial is a double blind, randomised,
placebo-controlled study of the Company's lead asset, SFX-01, in
patients with acute respiratory distress syndrome ("ARDS"). The
trial is co-sponsored by the University of Dundee and NHS Tayside
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 in
patients with suspected COVID-19. Patients may be included in the
study if they are infected with SARS-CoV-2 or other respiratory
infections causing community-acquired pneumonia.
Following this positive step, the next event in the trial
involves an assessment of safety and futility by the DMC of
unblinded data on the first 100 patients treated. In addition to
the DMC safety and futility assessment, Dundee University 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 Q2 of the calendar
year 2021.
Completion of recruitment to the STAR trial is anticipated at
the end of 2021/early 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
conclusion of the data monitoring committee with regard to safety
and data quality in the STAR COVID 19 study. The former conclusion
reinforces what we know about the positive safety and tolerability
of SFX-01 from previous studies and the latter is yet another
testament to the excellent work carried out by Professor James
Chalmers and his colleagues at Dundee under challenging
circumstances."
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
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)7876 741 001 / +44 (0)7980
Anna Dunphy / Paul McManus 541 893
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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