Evgen Pharma PLC Update on SAS study (3155K)
August 28 2019 - 1:00AM
UK Regulatory
TIDMEVG
RNS Number : 3155K
Evgen Pharma PLC
28 August 2019
Evgen Pharma plc
("Evgen Pharma" or "the Company")
Last patient visit reached in the SAS study, a phase II trial of
SFX-01 after subarachnoid haemorrhage
Evgen Pharma (AIM: EVG), a clinical stage drug development
company focused on the treatment of cancer and neurological
conditions, announces that the last study visit for the last
patient entered in the double-blind, placebo-controlled SAS Phase
II clinical trial has taken place. In the SAS trial, patients are
dosed for a maximum of 28 days following a subarachnoid
haemorrhage, covering the period at which they are at risk of a
Delayed Cerebral Ischaemia (DCI). Patients are then monitored for a
further five months to assess their recovery by collecting
endpoints including cognitive measurements and MRI scans.
The top line results for the primary endpoints of
safety/tolerability and blood flow, along with key secondary
endpoints measuring cognition, MRI and biomarkers, are expected to
be announced in Q4 2019, as previously communicated.
The trial recruited a total of 104 patients, split into two arms
in a randomised, double-blind, placebo-controlled trial. All
patients received the current standard of care, a calcium channel
blocker called Nimodipine in addition to SFX-01 or the placebo.
Nimodipine, first approved in the late eighties, offers a marginal
clinical improvement only and there remains a large clinical need
to reduce the cognitive deficits that can follow a DCI. The
clinical team is now focussed on the cleaning, validation and
analysis of the large volume of data collected in this trial.
The SAS trial will be the second Phase II clinical trial readout
from Evgen this year after it was announced in March that SFX-01
had successfully met the primary endpoints in the STEM trial - an
open label Phase II trial in patients with metastatic breast cancer
that had become resistant to hormone therapy and with demonstrable
progressive disease.
Steve Franklin, CEO of Evgen Pharma, said: "We look forward to
being able to announce the SAS clinical trial result later this
year. There has been no material innovation, in terms of new drugs
for treating subarachnoid haemorrhage (SAH), for approximately
thirty years and so a positive readout would represent significant
news for the pharmaceutical industry. On an annual basis, around
75,000 people have an SAH in the US and EU and, based on the most
recent analyst forecast, this could translate into peak sales of
approximately $500m. We have already secured orphan drug
designation in the US and the SAS trial will enable an application
for similar status in Europe."
Enquiries:
Evgen Pharma plc www.evgen.com via Walbrook
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Dr Stephen Franklin, CEO
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Richard Moulson, CFO
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finnCap www.finncap.com +44 (0) 20 7220 0500
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Geoff Nash / Teddy Whiley (Corporate
Finance)
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Alice Lane, Manasa Patil (ECM)
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WG Partners LLP +44 (0) 20 3705 9330
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Nigel Barnes / Claes Spång
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Walbrook PR +44 (0)20 7933 87870 or evgen@walbrookpr.com
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+44 (0)7980 541 893 / +44 (0)7876
Paul McManus / Anna Dunphy 741 001
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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.
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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