ReNeuron Group plc Stroke clinical trial regulatory approval in US (3015Z)
14 December 2017 - 6:01PM
UK Regulatory
TIDMRENE
RNS Number : 3015Z
ReNeuron Group plc
14 December 2017
14 December 2017 AIM: RENE
ReNeuron Group plc
("ReNeuron" or the "Company")
Stroke clinical trial regulatory approval in US
FDA approves ReNeuron's IND application to commence a Phase IIb
clinical trial in the US in stroke disability
ReNeuron Group plc (AIM: RENE), a global leader in the
development of cell-based therapeutics, is pleased to announce that
the FDA has 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. Patients with stable post-stroke
disability will be entered into the study 6 to 12 months after
their stroke and will be randomised to receive either the CTX
therapy or placebo treatment. 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
Modified Rankin Scale, a measure of disability and dependence, at 6
months post-treatment compared with baseline. Data from the study
are expected in late 2019.
Olav Hellebø, Chief Executive Officer of ReNeuron,
commented:
"We are delighted to have received regulatory approval to
commence our first clinical trial in the US with our CTX cell
therapy candidate for stroke disability. No therapeutic
interventions are currently available to improve motor function and
quality of life for disabled stroke patients. This important
clinical trial represents a further step towards potentially
meeting that very significant unmet need and we look forward to
initiating the study during the first half of next year."
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 Wills, 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 ReNeuron's CTX cell therapy candidate for stroke
disability
ReNeuron's CTX 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. A subsequent single
arm UK Phase II study (PISCES II) was recently completed, showing
positive responses on key measures of disability and dependency out
to 12 months post-treatment against a stable baseline level of
disability in the 23 patients treated.
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 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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