Evgen Pharma PLC First Patient Dosed in Phase II Trial (9482W)
03 Maggio 2016 - 8:01AM
UK Regulatory
TIDMEVG
RNS Number : 9482W
Evgen Pharma PLC
03 May 2016
For immediate release 3 May 2016
Evgen Pharma plc
("Evgen Pharma" or "the Company")
First Patient Dosed in Phase II Clinical Trial in SAH
Evgen Pharma plc (AIM: EVG), a clinical stage drug development
company focused on the treatment of cancer and neurological
conditions, is pleased to announce that the first patient has been
dosed in the Company's Phase II clinical trial of SFX-01 in
aneurysmal subarachnoid haemorrhage ("SAH"), a form of stroke.
SFX-01 is a synthetic version of sulforaphane, a known
neuroprotective and anti-cancer agent, which is stabilised in a
novel patented complex using a proprietary manufacturing
process.
The Phase II trial, SAS (SFX-01 after Subarachnoid Haemorrhage),
is a randomised, double blind, placebo controlled study comparing
oral SFX-01 with placebo. The trial will recruit 90 patients, 45 in
each treatment arm with all patients receiving nimodipine, the
current standard of care. Patients will be dosed within 48 hours of
experiencing SAH and approval has also been obtained in this study
to provide for emergency dosing prior to consent. The primary
endpoints include safety, pharmacokinetics and efficacy.
Nimodipine has been generic for more than 20 years, during which
time there have been no significant clinical advances in the
treatment of SAH. Whilst SAH is relatively rare, the market
potential for this devastating condition, with its high unmet
clinical need, is significant. In October 2015, Credit Suisse
(commissioned by a US peer) estimated potential peak sales of
$1.7bn by 2032 for a Phase III development product based on the
intraventricular delivery of a nimodipine-based formulation.
SFX-01 potentially represents a new class of drug in aneurysmal
SAH with a mechanism of action that specifically targets the Nrf-2
pathway, which in turn reduces the oxidative stress and the
toxicity caused by free haemoglobin from the haemorrhage.
Sulforaphane, the active ingredient of SFX-01, has been shown to be
neuroprotective in multiple models of cerebral damage, including
SAH.
It is expected that the SAS trial will report out Q2 2018.
Further details of the study are available at:
https://clinicaltrials.gov/ct2/show/study/NCT02614742
The Chief Investigator is Mr Diederik Bulters, Consultant
Neurosurgeon and Honorary Senior Clinical Lecturer, at the Wessex
Neurological Centre in Southampton.
Dr Stephen Franklin, Evgen Pharma's CEO, commented: "SAH is a
rare and devastating condition, with a high unmet clinical need.
Mechanistically, SFX-01 targets the principal drivers of the
delayed vasospasm and, unlike nimodipine, is not trying simply to
treat the vasospasm per se; as such it may represent the first
step-change improvement in therapy in over 20 years. The
commencement of the trial is a key milestone for the Company and I
would like to thank the Chief Investigator, Mr Diederik Bulters,
for his dedication and support."
Enquiries:
Evgen Pharma plc c/o +44 (0) 20
Dr Stephen Franklin, CEO 7466 5000
www.evgen.com
Buchanan
Mark Court, Sophie Cowles, Stephanie +44 (0) 20
Watson 7466 5000
Northland Capital Partners Limited
Matthew Johnson, Gerry Beaney, Margarita
Mitropoulou (Corporate Finance) +44 (0) 20
John Howes (Corporate Broking) 7382 1100
Notes for editors:
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. It is also carrying out preclinical work in
multiple sclerosis and has a clinical interest in prostate cancer.
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 Pharma commenced operations in January 2008 and is based
in Liverpool, UK, at the Liverpool Science Park. 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
About SAH and the SAS (SFX-01 after Subarachnoid Haemorrhage)
Trial
Aneurysmal SAH is a brain haemorrhage in which blood from a
ruptured aneurysm enters the subarachnoid space, a protective
barrier surrounding the brain. Aneurysmal SAH accounts for one in
every 20 strokes in the UK and approximately 600,000 individuals
suffer from it worldwide each year.
The current standard of care for patients with aneurysmal SAH is
to repair the aneurysm surgically to prevent re-bleeding. However,
a more severe complication of SAH is secondary ischemia caused by
vasospasm of blood vessels in the brain. This can lead to further
episodes of stroke, resulting in deterioration of the neurological
state impairing recovery and is associated with a poor outcome. The
current treatment option to prevent this secondary stroke is the
calcium channel blocker nimodipine, which has been generic for more
than 20 years during which time no significant clinical advances
have been made.
Under the design of the Company's Phase II trial, 45 patients
will receive SFX-01 and nimodipine and 45 will receive nimodipine
with a placebo. The primary endpoints include safety,
pharmacokinetic (cerebral spinal fluid) and efficacy as measured by
Middle Cerebral Artery (MCA) peak flow velocity. The secondary
endpoints include disability measures using the modified Rankin
Scale, the incidence of Delayed Cerebral Ischaemia (DCI) following
SAH, long term outcomes and various biomarker and other
pharmacokinetic measurements.
This information is provided by RNS
The company news service from the London Stock Exchange
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