ReNeuron Group plc Positive Phase 2a stroke clinical data published (1348D)
17 February 2020 - 6:00PM
UK Regulatory
TIDMRENE
RNS Number : 1348D
ReNeuron Group plc
17 February 2020
17 February 2020 AIM: RENE
ReNeuron Group plc
("ReNeuron" or the "Company")
Positive Phase 2a stroke clinical data published
ReNeuron Group plc (AIM: RENE), a global leader in the
development of cell-based therapeutics, is pleased to announce the
publication in a peer reviewed journal of positive clinical data
from the PISCES II Phase 2a clinical trial of its CTX stem cell
therapy candidate for disability resulting from stroke.
Data from the study were originally presented by Professor Keith
Muir at the American Heart Association International Stroke
Conference 2018 (ISC 2018) in January 2018, having been announced
by the Company in October 2017.
Data from the PISCES II clinical trial have been published
online in the Journal of Neurology, Neurosurgery, and Psychiatry in
a paper titled Intracerebral implantation of human neural stem
cells and motor recovery after stroke: multicentre prospective
single-arm study (PISCES-2)", Keith Muir et al.
http://jnnp.bmj.com/cgi/content/full/jnnp-2019-322515
PISCES II was a single arm, open-label study in patients living
with significant disability resulting from ischaemic stroke. A
total of 23 stable stroke patients with moderate to severe
disability were treated with a single dose of 20 million CTX cells
a median of seven months post-stroke. Clinically meaningful
improvements in disability scales were measured out to 12 months
post-implantation.
The greatest improvements on the Modified Rankin Scale (mRS), a
measure of disability and dependence, were seen in a pre-specified
group of fourteen subjects with residual movement of the affected
arm (NIHSS Upper Limb <4). Of these patients, 38.5% were
responders (at least a one-point improvement on mRS) at six months
post treatment and 50% were responders at twelve months post
treatment on this measure. 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.
The ongoing PISCES III study is a larger, randomised, placebo
controlled clinical trial designed to show a significant difference
in the proportion of patients with at least a one-point improvement
on mRS in a group receiving CTX stem cells compared to a group
receiving a sham-surgery procedure.
Olav Hellebø, Chief Executive Officer of ReNeuron,
commented:
"We are delighted to see the positive results of the PISCES II
clinical trial of our CTX cell therapy candidate for stroke
disability published in this highly regarded peer-reviewed
journal."
ENDS
Contacts:
ReNeuron +44 (0) 20 3819 8400
Olav Hellebø, Chief Executive Officer
Michael Hunt, Chief Financial Officer
Buchanan (UK Media/Investor Relations) +44 (0) 20 7466 5000
Mark Court, Tilly Abraham
Argot Partners (US Media/Investor Relations)
Claudia Styslinger, David Rosen +1 212 600 1902
Stifel Nicolaus Europe Limited (NOMAD and
Joint Broker)
Jonathan Senior, Stewart Wallace, Ben Maddison +44 (0) 20 7710 7600
N+1 Singer (Joint Broker)
Aubrey Powell, James Moat, Tom Salvesen +44 (0) 20 7496 3000
About ReNeuron
ReNeuron is a global leader in cell-based therapeutics,
harnessing its unique stem cell technologies to develop 'off the
shelf' stem cell treatments, without the need for immunosuppressive
drugs. The Company's lead clinical-stage candidates are in
development for the blindness-causing disease, retinitis
pigmentosa, and for disability as a result of stroke. ReNeuron is
also advancing its proprietary exosome technology platform 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. For further information
visit www.reneuron.com .
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END
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