TIDMRENE
RNS Number : 0636V
ReNeuron Group plc
31 October 2017
31 October 2017 AIM: RENE
ReNeuron Group plc
("ReNeuron" or the "Company")
Positive stroke clinical data & regulatory update
Long term data from Phase II stroke clinical trial confirm
positive results seen after three months
Results indicate that CTX cell therapy has potential to improve
long term outcomes in disability, dependence and motor function in
disabled stroke patients
ReNeuron Group plc (AIM: RENE), a UK-based global leader in the
development of cell-based therapeutics, today provides an update
regarding the Company's Phase II clinical trial (PISCES II) of its
CTX cell therapy candidate for stroke disability and, in addition,
an update regarding its global clinical and regulatory development
strategy for the stroke programme.
The Company is pleased to announce that the positive response
rates in key measures reported at three months after treatment in
the PISCES II clinical trial were sustained at 12 months after
treatment. PISCES II is a single arm, open-label study in patients
living with significant disability resulting from ischaemic stroke.
The Company announced positive initial data from the study in
December 2016, when all patients had been followed up for at least
three months after treatment.
At 12 months post-treatment, the response rates seen in the key
measures of disability and dependency were maintained. The primary
efficacy measure of the PISCES II study, motor function using the
Action Research Arm Test (ARAT), improved between three and 12
months post-treatment. Importantly, the Modified Rankin Scale (mRS)
response rate, a measure of disability and dependence, was
maintained with 7 out of 20 patients (35%) showing a clinically
relevant improvement. It is this measure of disability and
dependence that is likely to be carried forward as a primary
endpoint in future pivotal studies with CTX in this indication.
The PISCES II study also demonstrated that the CTX treatment was
well tolerated in both short and longer term follow-up. Detailed
safety and efficacy data from the study will be presented at a
forthcoming medical conference.
These positive long term results are highly encouraging,
indicating that the CTX therapy has the potential to produce
meaningful and sustained improvements in disability as well as
motor function in disabled stroke patients. No therapeutic
interventions are currently available to improve motor function and
quality of life for disabled stroke patients, with physical
rehabilitation measures being the current standard of care.
The Company will, as planned, shortly submit an Investigational
New Drug application to the FDA to commence a randomised,
placebo-controlled clinical trial in the US in disabled stroke
patients. This study will involve fewer patients than the study
originally planned with data expected to be available earlier, in
the second half of 2019. The Company will continue its discussions
with regulatory authorities worldwide but anticipates that a
further pivotal study will likely be required for global marketing
approval of the therapy.
Professor Keith Muir, SINAPSE Professor of Clinical Imaging,
Division of Clinical Neurosciences at the University of Glasgow,
and Principal Investigator of the PISCES II study, said:
"It is very encouraging to see that the improvements observed
earlier in the PISCES II study have been maintained at the 12 month
mark. As many patients live for the remainder of their lives with
disability following a stroke, it is important that benefits from
new treatments are maintained over the long term. In this regard,
the safety and side effects of treatments are also important; we
are pleased to see that the initial safety profile of CTX in this
study has also not changed with longer term follow up. We look
forward to the next phase of CTX development with investigation in
randomised, placebo-controlled studies."
Olav Hellebø, Chief Executive Officer of ReNeuron, said:
"We are delighted that the long term follow-up data from the
PISCES II clinical trial has shown the potential of our CTX cell
therapy candidate to permanently improve function in patients
living with chronic consequences following stroke. Further, the
study we plan to commence early in 2018 will allow critical
placebo-controlled data with CTX in stroke disability to be
available earlier than originally planned."
ENQUIRIES:
ReNeuron +44 (0) 20 3819 8400
Olav Hellebø , Chief Executive Officer
Michael Hunt, Chief Financial Officer
Buchanan +44 (0) 20 7466 5000
Mark Court, Sophie Cowles, Stephanie Watson
Stifel Nicolaus Europe Limited +44 (0) 20 7710 7600
Jonathan Senior, Stewart Wallace, Ben Maddison (NOMAD and Joint
Broker)
Nplus1 Singer Advisory LLP +44 (0) 20 7496 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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