ReNeuron Group plc Update on progress in ophthalmology programmes (9273C)
21 April 2017 - 4:00PM
UK Regulatory
TIDMRENE
RNS Number : 9273C
ReNeuron Group plc
21 April 2017
AIM: RENE 21 April
2017
ReNeuron Group plc
ReNeuron successfully develops cryopreserved formulation of its
retinal stem cell therapy candidate and expands ophthalmology
programmes
ReNeuron Group plc (the "Company") (AIM: RENE), a UK-based
global leader in the development of cell-based therapeutics,
provides an update on its cell therapy development programmes
targeting degenerative diseases of the retina.
We are pleased to report that we have successfully developed a
cryopreserved formulation of our human retinal progenitor cell
(hRPC) therapeutic candidate. The ability to cryopreserve our
retinal cell therapy candidate at drug product level represents a
major step forward for our retinal disease programme and mirrors
the earlier breakthrough we achieved with the cryopreservation of
our CTX cell therapy candidate. This new hRPC formulation enables
the cells to be frozen for shipping and storage and easily thawed
at the point of clinical use. This freeze-thaw modality enables a
greatly enhanced shelf life for the product, lower prospective cost
of goods and the capability to ship the cells for clinical and
commercial application anywhere on the globe.
As a result of the above development, we will shortly file an
application to the FDA seeking approval to switch from the fresh
hRPC formulation to the new cryopreserved formulation for dosing of
the third and final Phase I dose cohort of our ongoing US Phase
I/II clinical trial in retinitis pigmentosa (RP) patients. This
study, which is being conducted at Massachusetts Eye and Ear
Infirmary in Boston, is an open-label, dose escalation study to
evaluate the safety, tolerability and preliminary efficacy of our
hRPC stem cell therapy candidate in patients with advanced RP.
The new hRPC formulation has also allowed an expansion of
ReNeuron's clinical programmes in ophthalmology. Firstly, subject
to regulatory approval, we intend to expand the Phase II element of
the ongoing Phase I/II clinical trial in RP from six to 20 patients
in order to provide a richer data set from which to embark on a
subsequent Phase II/III pivotal study. In order to maintain patient
recruitment pace and reduce reliance on a single clinical site, we
also intend to open up further US clinical sites to this study. As
a consequence of these changes, we expect safety and tolerability
data from the Phase I part of the RP study in the first nine
patients later this year, with longer term safety data as well as
efficacy read-outs from the enlarged Phase II part of the study in
the second half of 2018.
Secondly, we intend to expand our hRPC retinal disease
programmes into a further disease indication, cone-rod dystrophy
(CRD). In contrast to RP, where the initial impact is a loss of
rods leading to a deterioration in peripheral vision and night
vision, CRD is a group of rare eye disorders associated with a loss
of cone cells in the retina that initially results in deterioration
of central visual acuity and colour vision. CRD frequently affects
patients in childhood and has no cure. It is an inherited orphan
disease that affects roughly 1 in 40,000 people.
The expansion of our ophthalmology programmes into CRD is part
of a broader strategy to evaluate the efficacy of our hRPC
therapeutic candidate across a range of genetic diseases of the
eye. We intend to file an application to commence a Phase II
clinical trial later this year in patients with CRD, to be run
alongside the Phase II part of the ongoing RP clinical trial.
Olav Hellebø, Chief Executive Officer of ReNeuron, said:
"We are delighted to be able to report these very significant
positive developments with our retinal disease programme. The
successful development of a cryopreserved formulation of our hRPC
retinal cell therapy candidate enables an expansion of our clinical
programmes in ophthalmology and also gives ReNeuron a significant
commercial advantage in terms of prospective cost of goods and ease
of use of a retinal disease therapy.
"The expansion of our retinal disease programmes into cone-rod
dystrophy and the enlargement of the Phase II part of the ongoing
clinical trial in retinitis pigmentosa reflect our strong belief in
the potential of our hRPC platform to benefit patients severely
affected by retinal diseases where no effective treatments are
currently available."
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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