TIDMEVG
RNS Number : 8646Q
Evgen Pharma PLC
11 June 2018
For immediate release 11 June 2018
Evgen Pharma plc
("Evgen" or "the Company")
Interim update on STEM trial
SFX-01 shows encouraging signs of anti-tumour activity
Evgen Pharma plc (AIM: EVG), a clinical stage drug development
company focused on the treatment of cancer and neurological
conditions, is pleased to announce an encouraging interim update on
STEM (SFX-01 in the Treatment and Evaluation of Metastatic Breast
Cancer), the Company's Phase II clinical trial in advanced breast
cancer.
This interim update, which the Company is able to provide
because the trial design is open label, comprises the first 20
patients to have completed the trial.
Patients recruited in STEM have previously responded to hormone
therapy (tamoxifen, aromatase inhibitors or fulvestrant) for at
least six months but have then been diagnosed with progressive
disease, indicating secondary resistance to the hormone therapy.
Patients in STEM continue on their hormone therapy but also receive
SFX-01. They have six-weekly scans and are discontinued from the
study as soon as a scan shows progressive disease or progress is
evident on symptomatic grounds. The maximum period on the trial is
24 weeks; patients who respond to the drug can access SFX-01 after
that time via a compassionate use programme.
It should be noted that this interim update should be
interpreted with due caution as the final results of the trial may
differ.
At this interim stage, in the opinion of the Principal
Investigator, Dr Sacha Howell, and of the Company's Chief Medical
Advisor:
-- SFX-01 is proving to be well tolerated with no safety concerns arising
-- SFX-01 shows encouraging early signs of anti-tumour activity:
- Four patients had their disease stabilised (that is, having
joined the trial with progressive disease their tumours stopped
progressing) for the full duration of the study through to, and
including, a favourable final scan result at week 24. Of these four
patients, one also had a partial response which is a reduction in
tumour size of at least 30% on one scan
- In addition to the above four patients, a further two patients
had their disease stabilised through to, and including, the week 18
scan but then showed disease progression at the final week 24 scan.
One of these two patients also demonstrated a partial response on
one scan before disease progression was recorded at the final
scan
All patients that have a favourable week 18 scan are registered
in the compassionate use programme to ensure continuity of drug
between the final week 24 scan and the scan result, which can be
some time later. Those that have a favourable week 24 scan continue
on the programme.
STEM, which will include up to 60 patients, remains on track to
report around the end of 2018 with 14 sites having already
recruited a total of 44 patients across the UK, Belgium, Spain and
France. The 44 patients include the 20 patients in this interim
update.
The primary endpoints of the study are: safety and tolerability,
and clinical benefit rate at 24 weeks, that is, the proportion of
patients with no disease progression after 24 weeks of therapy
(this includes stable disease, partial response and complete
response).
Putting this interim update into a clinical context, the trial's
Principal Investigator, Dr Sacha Howell of the Christie Hospital,
Manchester, UK, said:
"The design of the STEM study, adding the drug to endocrine
therapy on which a patient's cancer was progressing, sets a high
bar for SFX-01. In light of this, these interim results are highly
encouraging. Objective responses indicate activity in this setting,
and disease stabilisation for 6-12+ months represents clinically
meaningful prolongation of response. SFX-01 is generally well
tolerated and the results together, should they look similar in the
final analysis, suggest further investigation of SFX-01 in advanced
breast cancer is warranted."
Prof Francois Duhoux, of University Clinics St-Luc, Brussels,
and the Belgium national coordinator for the trial, said:
"Six of these first 20 patients came through my clinic and I can
confirm the excellent safety profile of SFX-01. These patients have
metastatic disease and have demonstrated progression on their
endocrine therapy prior to coming on the trial, and, instead of
switching to an alternative regimen, they continued their endocrine
therapy with the addition of SFX-01. While we must of course wait
for the results of the entire study before making any definitive
judgment, in this context I think that the initial results
pertaining to efficacy are highly encouraging."
Dr Steve Franklin, Evgen's CEO, commented:
"This initial data is promising. We can add that two of the
first 20 patients in the trial have been on SFX-01 for
approximately one year - six months in the trial and a further six
months in the compassionate use programme. One of these patients
remains on the drug to this day. This extended treatment makes an
important contribution to our understanding of the product's
longer-term tolerability and safety and highlights its potential
patient benefit."
Enquiries:
Evgen Pharma plc c/o +44 (0) 20 7466 5000
Dr Stephen Franklin, CEO
Richard Moulson, CFO
www.evgen.com
Buchanan
Mark Court, Sophie Wills, Tilly Abraham +44 (0) 20 7466 5000
Northland Capital Partners Limited
Matthew Johnson, Tom Price (Corporate Finance)
John Howes, Rob Rees (Corporate Broking) +44 (0) 20 3861 6625
Notes for editors:
About Evgen Pharma plc
Evgen 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.
Evgen 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
For commissioned research on the Company, please visit:
http://evgen.com/investors/analyst-coverage/
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END
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