Evgen Pharma PLC Clinical trial update confirms read-outs on track (0442P)
05 February 2019 - 6:00PM
UK Regulatory
TIDMEVG
RNS Number : 0442P
Evgen Pharma PLC
05 February 2019
For immediate release 5 February 2019
Evgen Pharma plc
("Evgen" or "the Company")
Clinical trial update confirms read-outs on track
Last patient recruited to SAS Phase II trial and last patient
completes STEM Phase IIa trial
Evgen Pharma plc (AIM: EVG), a clinical stage drug development
company focused on the treatment of cancer and neurological
conditions, is pleased to announce the following clinical trial
update.
SAS Phase II trial
Patient recruitment has completed in the SAS Phase II trial of
SFX-01 in subarachnoid haemorrhage. As patients are dosed for a
maximum of 28 days, the Company anticipates, in-line with market
expectation, the read-out of the primary endpoints of the trial in
Q2 calendar year 2019.
The SAS trial is a randomised, double blind, placebo-controlled
trial which has now recruited 90 patients. The primary endpoints of
SAS relate to safety, tolerability and blood flow as measured by
Transcranial Doppler ("TCD") ultrasound. TCD provides a rapid,
non-invasive, real-time measurement of blood flow in the basal
arteries of the brain thereby detecting the Delayed Cerebral
Ischaemia that affects a significant proportion of patients in the
days following the initial haemorrhage.
The important secondary endpoints, which include the assessment
of patients' cognitive function at three and six months post
haemorrhage, will read-out in late summer 2019.
STEM Phase IIa trial
The Company is also pleased to announce that the last patient
recruited to the STEM trial of SFX-01 in metastatic breast cancer
has now completed her last visit in the trial, having reached the
24-week end-point without disease progression. She has now entered
the compassionate use programme.
The STEM trial is an open label, multi-centre, Phase IIa trial
of patients with ER+ metastatic breast cancer who had been on
treatment with tamoxifen, aromatase inhibitors or fulvestrant. All
patients had previously responded to their hormone therapy but then
presented with progressive disease, demonstrating the start of
resistance. The primary endpoints of the trial are safety,
tolerability and clinical benefit rate as measured by RECIST
(Response Evaluation Criteria in Solid Tumours).
An encouraging interim review of the STEM trial data was
announced on 11 June 2018 and the Company continues to expect the
final data read-out in the latter part of Q1 2019.
Dr Stephen Franklin, CEO of Evgen, commented:
"The recruitment phase of SAS is completed and we would like to
take this opportunity to thank the clinical centres that helped
achieve this milestone. Furthermore, with the completion of the
treatment phase of STEM we would like to thank the clinicians and
nurses at all the hospitals that participated in this European
study. We look forward to the read-outs of the STEM and SAS trials
and expect this to be a transformative year for the Company."
Enquiries:
Evgen Pharma plc c/o +44 (0) 20 7466 5000
Dr Stephen Franklin, CEO
Richard Moulson, CFO
www.evgen.com
finnCap
Geoff Nash, Teddy Whiley (Corporate
Finance)
Alice Lane, Manasa Patil (ECM)
www.finncap.com +44 (0) 20 7220 0500
WG Partners LLP
Nigel Barnes, Claes Spång +44 (0) 20 3705 9330
Buchanan
Mark Court, Sophie Wills, Tilly
Abraham
evgen@buchanan.uk.com +44 (0) 20 7466 5000
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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