Evgen Pharma PLC Final Patient Recruited in STEM Phase IIa Trial (6414V)
July 25 2018 - 1:00AM
UK Regulatory
TIDMEVG
RNS Number : 6414V
Evgen Pharma PLC
25 July 2018
For immediate release 25 July 2018
Evgen Pharma plc
("Evgen" or "the Company")
Final patient recruited in the STEM Phase IIa trial
Evgen Pharma plc (AIM: EVG), a clinical stage drug development
company focused on the treatment of cancer and neurological
conditions, announces that it has concluded patient recruitment in
its STEM Phase IIa trial of SFX-01 in metastatic breast cancer.
STEM is an open label trial that had regulatory approval to
recruit 60 patients. Following the favourable interim read-out,
announced on 11 June 2018, the Principal Investigator and the
Company's medical adviser believe there is sufficient evidence to
conclude that the main aims of the trial, being a favourable safety
and tolerability profile and evidence of clinical benefit, have
been successfully met. On this basis, the Company has decided that
there is no merit in recruiting the full number of patients allowed
under the protocol.
As at 24 July 2018, 50 patients had been enrolled in the trial.
Any eligible patients currently in screening will also be admitted
to the trial.
All eligible patients will continue as per the trial protocol,
and will receive SFX-01 until such point as they show clinical
progression or reach the end of the trial at 6 months. If they
receive clinical benefit for the full duration of the trial, like
all other patients in the trial, they will be eligible for entry
into the compassionate use programme. On this basis, the final
readout will occur around the end of the calendar year; this will
include details of the safety, tolerability and the clinical
benefit rate observed across all patients.
Dr Sacha Howell, Principal Investigator and Senior Lecturer and
Honorary Consultant in Medical Oncology at the Christie NHS
Foundation Trust, said:
"The STEM trial is an exploratory trial that was designed to
demonstrate safety and tolerability with long-term exposure to
SFX-01 and to provide evidence that it has anti-tumour activity
after failure of at least one and up to three prior hormone
therapies. With these objectives in mind, we have sufficient
evidence to believe that SFX-01 warrants further investigation
through the conduct of a randomised placebo-controlled trial."
Dr Stephen Franklin, CEO of Evgen, commented:
"We are excited that, so far, the data from our exploratory STEM
trial supports further clinical evaluation of SFX-01 and we look
forward to the final read-out around the end of the calendar year.
The next step is likely to be a placebo-controlled trial, testing
SFX-01 in combination with second-line hormone therapy in patients
that have failed on CDK4/6 inhibitors. This is the initial setting
for which we wish to see SFX-01 approved in metastatic breast
cancer."
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, Gerry Beaney
(Corporate Finance)
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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