TIDMRENE
RNS Number : 8916Q
ReNeuron Group plc
05 December 2016
5 December 2016 AIM: RENE
ReNeuron Group plc
("ReNeuron" or the "Company")
Reports positive results in Phase II stroke trial
ReNeuron Group plc (AIM: RENE), a UK-based global leader in the
development of cell-based therapeutics, is pleased to announce
positive data from the Company's Phase II clinical trial (PISCES
II) of its CTX cell therapy candidate for stroke disability.
PISCES II is a single arm, open-label study in patients living
with disability resulting from ischaemic stroke. The study's
primary endpoint was for two patients to reach a minimum two-point
improvement in the grasping and lifting test, sub-test number 2, of
the Action Research Arm Test ("ARAT"), at three months
post-treatment. Three of the 21 patients achieved this at three,
six or twelve months respectively after treatment and were within a
group of four responders who also showed clinically relevant
improvements on the total ARAT score of arm motor performance.
Although the ARAT sub-test number 2 study endpoint was not met as
some responses came later than the three-month target, the result
is nonetheless highly encouraging.
Strongly positive results were also seen in the other endpoints
of the study, with seven patients (33%) showing a clinically
relevant improvement on the Modified Rankin Scale (a measure of
disability and dependence) and eight patients (38%) showing a
clinically relevant improvement on the Barthel Index (a measure of
performance in activities of daily living). In total, 15 out of 21
patients had a clinically significant response on at least one
efficacy measure. Improvements in the ARAT scores, Modified Rankin
Scale and Barthel Index were all sustained throughout the follow up
period.
As a result of the positive data from the PISCES II study, the
Company intends to apply to the US and European regulatory
authorities to commence a randomised, placebo-controlled, pivotal
clinical trial in patients who are living with disability
post-stroke.
Patients in the PISCES II study were monitored prior to
treatment to ensure that their disability was stable and showing no
spontaneous improvement. A dose of 20 million CTX cells was
administered to the patients between two and thirteen months
(median seven months) after the stroke via direct injection
adjacent to the area of the brain with the stroke damage. Patients
were monitored for changes in arm function as well as a range of
measures to assess disability and activities of daily living. All
21 patients in the study have completed three-month follow-up, with
ten patients followed for six months and three for twelve months.
Further data will continue to be collected until all patients have
reached 12 months post treatment.
The PISCES II study also demonstrated that the CTX treatment was
well tolerated. The most common adverse events were transitory and
related to the surgical procedure, such as headache and nausea.
Safety and efficacy data from the study will be presented at
forthcoming stroke and rehabilitation medical conferences.
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:
"The findings of the PISCES II study are encouraging in that the
CTX treatment shows improvements both in specific neurological
problems, such as arm function, and also in more general disability
and independence. These improvements occurred in sufficient numbers
of patients to warrant further investigation in a larger,
controlled clinical study. Further, the CTX treatment was well
tolerated in this Phase II study, which confirms and adds to the
results of the earlier Phase I clinical trial. We look forward to
the opportunity to further test the efficacy of this potential new
treatment for disabled stroke survivors."
Olav Hellebø, Chief Executive Officer of ReNeuron, said:
"We are delighted that the PISCES II clinical trial has shown
our CTX cell therapy candidate has the potential to become a
treatment option for patients living with chronic consequences
following stroke. We are particularly excited by the response rate
seen on the measures relating to disability and activities of daily
living, given that these are the most important for patients and
their carers. These measures are also the ones viewed by regulatory
authorities as most relevant for late-stage clinical
development.
"We are extremely grateful to the patients who volunteered for
the PISCES II study and to the stroke research teams across the UK
who have been involved in this ground-breaking clinical trial.
"Based on these positive results we will move into a controlled
clinical trial to further assess the efficacy of CTX treatment in a
significantly larger cohort of patients. We have a strong balance
sheet to fund this pivotal study as well as reaching other
important milestones across our development pipeline."
Analyst meeting and webcast:
A meeting for analysts will be held at 9.00am today at the
offices of Buchanan, 107 Cheapside, London, EC2V 6DN. For a webcast
of the analyst presentation, please log on to the following web
address approximately 10 minutes before 9.00am:
http://vm.buchanan.uk.com/2016/reneuron051216/registration.htm
For further details please contact Buchanan on 020 7466
5000.
A recording of the webcast will be made available on ReNeuron's
and Buchanan's websites, www.reneuron.com and
www.buchanan.uk.com.
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 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 21 patients were treated between
two and thirteen months post-stroke and have been followed-up for
at least 3 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.
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 recently 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 treatment for ischaemic stroke patients occurs
in the acute phase of the condition (within several hours of the
stroke), when anti-clotting agents are administered to dissolve the
clot causing the blockage in blood flow to the brain. Only a small
proportion of patients get to the hospital in time 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 motor 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 gene therapy treatments.
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 announcement contains forward-looking statements with
respect to the financial condition, results of operations and
business achievements/performance of ReNeuron and certain of the
plans and objectives of management of ReNeuron with respect
thereto. These statements may generally, but not always, be
identified by the use of words such as "should", "expects",
"estimates", "believes" or similar expressions. This announcement
also contains forward-looking statements attributed to certain
third parties relating to their estimates regarding the growth of
markets and demand for products. By their nature, forward-looking
statements involve risk and uncertainty because they reflect
ReNeuron's current expectations and assumptions as to future events
and circumstances that may not prove accurate. A number of factors
could cause ReNeuron's actual financial condition, results of
operations and business achievements/performance to differ
materially from the estimates made or implied in such
forward-looking statements and, accordingly, reliance should not be
placed on such statements.
This information is provided by RNS
The company news service from the London Stock Exchange
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December 05, 2016 02:46 ET (07:46 GMT)