TIDMRENE
ReNeuron Group plc
26 January 2018
26 January 2018 AIM: RENE
RNS REACH
ReNeuron Group plc
("ReNeuron" or the "Company")
Phase II stroke data presented at AHA conference
Positive long-term data from Phase II stroke disability clinical
trial accepted for a late-breaking podium presentation at the
American Heart Association International Stroke Conference 2018
ReNeuron Group plc (AIM: RENE), a UK-based global leader in the
development of cell-based therapeutics, is pleased to announce that
positive long-term data from the Phase II clinical trial (PISCES
II) of its CTX cell therapy candidate for stroke disability was
accepted for a podium presentation given yesterday at the American
Heart Association International Stroke Conference 2018 ("ISC
2018"), taking place this week in Los Angeles.
PISCES II is a single arm, open-label study in which a total of
23 patients living with significant disability resulting from
ischaemic stroke were treated with ReNeuron's CTX cell therapy
candidate. The Company recently announced positive top-line
long-term data from the PISCES II clinical trial in which response
rates in key measures reported at 3 months after CTX cell treatment
were sustained at 12 months post-treatment.
Professor Keith Muir, SINAPSE Chair of Clinical Imaging,
Clinical Director for Stroke, Queen Elizabeth University Hospital,
Glasgow, and Principal Investigator for the PISCES II study,
presented data at the conference showing upper limb functional
recovery was durable and maintained out to 12 months
post-treatment, with 30% of patients responding on the ARAT scale,
a measure of upper limb mobility.
Data was also presented showing a response rate in 30% of
subjects at 12 months post-treatment of at least a one point
improvement on the modified Rankin Scale (mRS), a 7-point,
clinician-reported global measure of disability or dependence upon
others in carrying out activities of daily living. A one-point
improvement in mRS is proven to be clinically meaningful for
patients, both in terms of quality of life and healthcare resources
needed to care for them. For example, improving from mRS 3 to 2
means that a person with a stroke regains their ability to live
independently; perhaps returning home from a care facility, or
enabling a spouse or carer to return to work.
Further, data analysis from a pre-specified subgroup of patients
in the PISCES II study who had residual upper limb movement was
presented, showing the appreciably higher response rate of 43% in
these patients on the mRS. Patients similar to those in this
subgroup, with moderate or moderate-to-severe disability (mRS of 3
or 4) and some remaining arm movement, will be the target
population for the Company's upcoming PISCES III clinical trial
with its CTX cell therapy candidate.
The data presented at the ISC 2018 conference indicate that the
CTX therapy has the potential to produce meaningful and sustained
improvements in the level of disability or dependence as well as
motor function in disabled stroke patients. The PISCES II study
also demonstrated that the CTX treatment was well-tolerated in both
short and longer term follow-up.
ReNeuron recently announced that the FDA had given regulatory
approval for the Company to commence a Phase IIb clinical study in
the US with its CTX cell therapy candidate for stroke disability.
The study, designated PISCES III, is a randomised,
placebo-controlled clinical trial involving 110 patients across 25
clinical trial sites in the US. The primary end-point of the study
will be a comparison of the proportion of patients in the treated
and placebo arms showing a clinically important improvement on the
mRS at 6 months post-treatment compared with baseline. Data from
the study are expected in late 2019.
A copy of the ISC 2018 presentation will shortly be available on
ReNeuron's website.
Further information about the conference may be found at:
http://professional.heart.org/professional/EducationMeetings/MeetingsLiveCME/InternationalStrokeCofnerence/UCM_316901_International-Stroke-Conference.jsp
ENQUIRIES:
+44 (0)20 3819
ReNeuron 8400
Olav Hellebø , Chief Executive Officer
Michael Hunt, Chief Financial Officer
+44 (0) 20 7466
Buchanan 5000
Mark Court, Sophie Wills, Stephanie Watson
+44 (0) 20 7710
Stifel Nicolaus Europe Limited 7600
Jonathan Senior, Stewart Wallace, Ben Maddison
(NOMAD and Joint Broker)
+44 (0) 20 7496
Nplus1 Singer Advisory LLP 3000
Mark Taylor (Joint Broker)
About the PISCES II clinical trial
The PISCES II clinical trial is a UK study of patients with
motor disability as a result of ischaemic stroke. Eight centres
across the UK's NHS hospital service were involved in recruiting
and treating patients. A total of 23 patients were treated between
two and thirteen months post-stroke, of which 20 have been followed
up for at least 12 months. The patients were dosed with 20 million
CTX cells which were injected by way of a routine surgical
procedure into the putamen, the region of the brain involved in
learning and coordinating movement. Patients were typically
discharged home following a day of recovery in hospital. Patients
in the study also received physiotherapy following their surgery.
Arm and leg motor performance was tested in the study using Action
Research Arm Test and Fugl-Meyer Assessment. Stroke severity and
ability to carry out routine daily tasks were also measured, using
the National Institutes of Health Stroke Scale, Modified Rankin
Scale and Barthel Index. The PISCES II study was part-funded by a
regenerative medicine and cell therapy development grant from
Innovate UK, the UK's innovation agency.
About ReNeuron's CTX stem cell therapy candidate for stroke
disability
ReNeuron's CTX stem cell therapy candidate for stroke disability
consists of a neural stem cell line which has been generated using
the Company's proprietary cell expansion and cell selection
technologies and then taken through a full manufacturing scale-up
and quality-testing process. As such, CTX is a cryopreserved,
clinical and commercial-grade cell therapy product capable of
treating all eligible patients presenting.
CTX has been shown to be safe and well tolerated in an initial
UK clinical trial (PISCES I) in eleven disabled stroke patients who
were followed up for at least two years post-treatment. The data
from this study were published in The Lancet. If ultimately shown
to be safe and effective in larger, controlled clinical studies,
CTX would therefore offer a ground breaking new treatment option
for stroke survivors. The therapy offers the potential for a degree
of recovery of function in disabled stroke patients, resulting in
greater independence and quality of life for these patients and
reduced reliance on health and social care systems.
The CTX cells that were used in the both the PISCES I and PISCES
II clinical trials were taken from the existing manufactured cell
banks that will form the basis of the eventual marketed product.
There will therefore be no need to re-derive and test new CTX cell
lines for subsequent clinical trials or for the market - all such
cells can simply be expanded from the existing banked and tested
product.
About stroke
Approximately 150,000 people suffer a stroke in the UK each year
and approximately 800,000 in the US. The vast majority of these
strokes are ischaemic in nature, caused by a blockage of blood flow
in the brain (as opposed to a haemorrhagic or bleeding stroke).
Approximately one half of all stroke survivors are left with
permanent disabilities as a result of the damage caused to brain
tissue arising from the stroke. The annual health and social costs
of caring for these patients is estimated to be in excess of GBP5
billion in the UK and over $70 billion in the US, with stroke
patients estimated to be occupying at least 25 per cent of long
term hospital beds.
The only current treatments for ischaemic stroke patients occur
in the acute phase of the condition (within several hours of the
stroke). During this phase, anti-clotting agents can be
administered to dissolve the clot causing the blockage in blood
flow to the brain or, alternatively, retrieval devices can be used
to remove the clot and restore blood flow. Only a small proportion
of patients are currently eligible to be treated in this way.
Beyond the acute phase, there are no existing treatments, other
than preventative or rehabilitation measures, to alleviate the
disabilities suffered by stroke patients who have survived their
stroke.
Source: UK Stroke Association; American Stroke Association
About ReNeuron
ReNeuron is a leading, clinical-stage cell therapy development
company. Based in the UK, its primary objective is the development
of novel cell-based therapies targeting areas of significant unmet
or poorly met medical need.
ReNeuron has used its unique stem cell technologies to develop
cell-based therapies for significant disease conditions where the
cells can be readily administered "off-the-shelf" to any eligible
patient without the need for additional immunosuppressive drug
treatments. The Company has therapeutic candidates in clinical
development for disability as a result of stroke, for critical limb
ischaemia and for the blindness-causing disease, retinitis
pigmentosa.
ReNeuron is also advancing its proprietary exosome technology
platform as a potential new nanomedicine targeting cancer and as a
potential delivery system for drugs that would otherwise be unable
to reach their site of action.
ReNeuron's shares are traded on the London AIM market under the
symbol RENE.L. Further information on ReNeuron and its products can
be found at www.reneuron.com.
This information is provided by RNS
The company news service from the London Stock Exchange
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