REG - ReNeuron Group plc - Positive Phase 2a stroke clinical data published

ReNeuronAnnouncement

17/02/2020 07:00

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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
(https://linkprotect.cudasvc.com/url?a=http%3a%2f%2fjnnp.bmj.com%2fcgi%2fcontent%2ffull%2fjnnp-2019-322515&c=E,1,t6683LTLAnfV33k2SA-X8IDg2vXEZRnTADZyT0yQMpZq0B5XxLQlBmwCo7MjjMc4MSpvfrwj30qjg5uKFGWJfbTbOZGeCD87PHb9souFiBLVvGBvnQojZlKA&typo=1)
 

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)             +1 212 600 1902

 Claudia Styslinger, David Rosen

 Stifel Nicolaus Europe Limited (NOMAD and Joint Broker)  +44 (0) 20 7710 7600

 Jonathan Senior, Stewart Wallace, Ben Maddison

 N+1 Singer (Joint Broker)                                +44 (0) 20 7496 3000

 Aubrey Powell, James Moat, Tom Salvesen

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
(http://www.reneuron.com) .

 

 

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