Evgen Pharma PLC SFX-01 results in SAS study (8825S)
November 11 2019 - 2:00AM
UK Regulatory
TIDMEVG
RNS Number : 8825S
Evgen Pharma PLC
11 November 2019
Evgen Pharma plc
("Evgen Pharma" or the "Company")
SFX-01 results in SAS study
Evgen Pharma (AIM: EVG), a clinical stage drug development
company focused on the treatment of cancer and neurological
conditions, announces the results of the "SFX-01 after subarachnoid
haemorrhage" (SAS) trial.
The primary endpoint of reducing blood flow velocity in the
middle cerebral artery was not achieved, with no significant
difference between the SFX-01 and placebo arms.
Furthermore, whilst the secondary endpoints were not
statistically powered, there were no differences seen between
SFX-01 and placebo in key cognition, quality of life and clinical
outcomes at three and six months.
SFX-01 was however shown to be well-tolerated with no safety
concerns.
In the multi-centre, randomised, double-blind,
placebo-controlled SAS Phase II clinical trial, patients were dosed
for a maximum of 28 days following a subarachnoid haemorrhage
(SAH), covering the period at which they are at risk of a Delayed
Cerebral Ischaemia (DCI). Patients were then monitored for a
further five months to assess their recovery by collecting
endpoints including cognitive measurements.
In March, the Company reported very positive data from its Phase
II STEM trial for the treatment of metastatic breast cancer. Evgen
remains well funded and will concentrate its efforts on future
partnering whilst developing product formulation for use in STEM II
and other investigator-led clinical studies.
Steve Franklin, CEO of Evgen Pharma, said: "We are surprised and
disappointed by these findings given the strong preclinical data
for sulforaphane in animal models of SAH and other forms of stroke.
In March, we reported that SFX-01 had demonstrated positive
efficacy and safety data in our STEM trial for metastatic breast
cancer, so it is naturally disappointing not to have followed this
with another positive result.
"Having achieved our primary endpoints in the metastatic breast
cancer Phase II trial, and considering our support for
investigator-led clinical studies in alternative disease areas, we
will continue to pursue attractive commercial opportunities for
SFX-01. However, we will review our Company strategy relating to
SFX-01's therapeutic applications, and further announcements will
be made in due course."
Enquiries:
Evgen Pharma plc www.evgen.com via Walbrook
Dr Stephen Franklin, CEO
Richard Moulson, CFO
finnCap www.finncap.com +44 (0) 20 7220 0500
Geoff Nash / Teddy Whiley (Corporate
Finance)
Alice Lane, Manasa Patil (ECM)
WG Partners LLP +44 (0) 20 3705 9330
Nigel Barnes / Claes Spång
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 whose
lead programmes are in breast cancer and subarachnoid haemorrhage,
a type of stroke. 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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END
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