ReNeuron Group plc Update on clinical strategy in stroke disability (9274C)
April 21 2017 - 2:01AM
UK Regulatory
TIDMRENE
RNS Number : 9274C
ReNeuron Group plc
21 April 2017
AIM: RENE 21 April
2017
ReNeuron Group plc
ReNeuron advances global clinical development strategy with cell
therapy candidate for stroke disability
ReNeuron Group plc (the "Company") (AIM: RENE), a UK-based
global leader in the development of cell-based therapeutics, is
pleased to provide an update on its CTX-based cell therapy
development programmes.
In December 2016, we announced positive data from the Phase II
clinical trial (PISCES II) of our 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. As
a result of the positive data from this study, we are pursuing our
plans to commence a randomised, placebo-controlled, Phase III
clinical trial in the USA and Europe in patients who are living
with disability post-stroke. As part of these preparations, we are
conducting an End of Phase II meeting with the FDA later this month
in order to seek further regulatory guidance prior to our
submitting a formal application ("IND") to commence the US arm of
the Phase III study. Subject to the feedback from this meeting, we
plan to file the IND later this quarter with the aim of commencing
the Phase III study in the second half of this year.
Separately, we have consulted with the European Medicines Agency
on our plans for the Phase III stroke study. We have taken the
advice received into account when developing our protocol for the
study. In this regard, we intend to file a clinical trial
application to regulatory authorities in Europe, shortly after the
corresponding US submission.
Meetings with the Japanese regulatory agency ("PDMA") are also
ongoing in order to advance our CTX cell therapy candidate for
stroke disability in Japan under regulations that offer the
potential for conditional marketing approval for cell therapies at
an earlier stage of clinical development.
In order to focus on the significant opportunity presented by
our stroke disability programme and our expanded retinal disease
programmes (see separate announcement issued this morning), we have
decided to put the programme for critical limb ischaemia on hold
for the time being. Patient dosing was recently completed in a
Phase I safety study in this indication, with no significant
adverse safety events reported post-administration of the CTX cells
via intramuscular injections.
Olav Hellebø, Chief Executive Officer of ReNeuron, said:
"There are currently no therapeutic interventions available to
patients living with disability resulting from acute ischaemic
stroke. We are therefore excited to be moving closer towards
potentially changing this situation with our therapeutic candidate
targeting stroke disability. After collecting further feedback from
US and European regulatory authorities, we expect to be able to
commence a Phase III study with our CTX cell therapy candidate in
stroke disability in the second half of this year. We look forward
to reporting further progress over the months ahead."
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
END
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