ReNeuron Group plc Stroke clinical data published in The Lancet (1850G)
August 04 2016 - 1:00AM
UK Regulatory
TIDMRENE
RNS Number : 1850G
ReNeuron Group plc
04 August 2016
4 August 2016 AIM: RENE
ReNeuron Group plc
Stroke clinical data published in The Lancet
Published long term Phase I data show evidence of improvements
in neurological function sustained out to 24 months and good safety
profile
ReNeuron Group plc (the "Company") (AIM: RENE), a UK-based
global leader in the development of cell-based therapeutics, is
pleased to announce the publication of long term follow up data
from its PISCES I stroke clinical trial in The Lancet.
The PISCES I study was the first clinical trial of ReNeuron's
CTX cell therapy candidate for patients with motor disability as a
consequence of ischaemic stroke. The Lancet paper describes
two-year follow up clinical data relating to the eleven stroke
patients treated in the study.
The study was designed primarily to determine the safety of the
CTX cell therapy candidate in patients with stable motor disability
following their stroke. A number of secondary endpoints were also
monitored to investigate possible signals of efficacy in the
participants taking part in the study. Patients in the study were
treated from twelve to fifty one months after stroke onset.
As previously reported at the 2015 European Stroke Conference,
improvements in neurological status and limb function compared with
pre-treatment baseline performance were observed within three
months of treatment and maintained throughout long term follow up.
Improvements in the National Institutes of Health Stroke Scale
("NIHSS") were seen in all dose groups. The NIHSS is a scale used
to measure the neurological impairment caused by a stroke. For all
subjects, the mean baseline score was 7.45. This improved to 5.09
at three months and was sustained at two years follow up with a
mean score of 4.91 (p=0.002).
Improvements in other measures of neuromuscular disability were
supportive of the NIHSS results. Ashworth Scale scores, a measure
of limb spasticity, showed sustained improvement over the course of
the two year study in both the affected arm and leg (mean
improvement of 2.5 and 3.7 points). Scores on the Barthel Index, a
measure of activities of daily living, also demonstrated
improvement over the course of the study with a median improvement
of 2 points at two years after treatment.
There were no cell-related or immunological adverse events
reported in any of the patients treated in the PISCES I study
across the four ascending dose levels.
The Lancet paper can be found at:
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)30513-X/abstract
(Kalladka et al. The Lancet, 3 August 2016.
http://dx.doi.org/10.1016/S0140-6736(16)30513-X)
ReNeuron recently reported that patient recruitment has
completed into the on-going Phase II clinical trial (PISCES II) of
its CTX cell therapy candidate in stroke. The three month follow up
data from this study are expected to be available in the fourth
quarter of this year. The Company also reported that it has
commenced formal interactions with regulatory authorities in Europe
and the US regarding plans for a randomised, controlled, pivotal
Phase II/III clinical trial with CTX in stroke disability. Subject
to the results of the PISCES II study, the Company expects to file
an application in the first quarter of 2017 to commence this
pivotal Phase II/III clinical trial.
Professor Keith Muir, SINAPSE Professor of Clinical Imaging,
Division of Clinical Neurosciences at the University of Glasgow,
and Principal Investigator of the PISCES I study, said:
"The long term follow up data from the PISCES I study are both
pleasing and encouraging. The data demonstrate the safety and
tolerability of the CTX cell therapy treatment and the evidence of
functional improvements have justified further investigation in the
ongoing PISCES II efficacy study."
Olav Hellebø, Chief Executive Officer of ReNeuron, said:
"We are delighted that the PISCES I clinical trial data has been
published in such a prestigious peer reviewed medical journal as
The Lancet. The data from this study have provided us with the
impetus to move our CTX cell therapy candidate for stroke
disability into the ongoing PISCES II clinical trial. We look
forward to reporting the three month follow up data from this Phase
II study later this year."
ENDS
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 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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