ReNeuron Group plc FDA approves cryopreserved hRPC formulation (4005I)
19 June 2017 - 4:00PM
UK Regulatory
TIDMRENE
RNS Number : 4005I
ReNeuron Group plc
19 June 2017
AIM: RENE 19 June
2017
ReNeuron Group plc
FDA approves cryopreserved formulation of ReNeuron's retinal
stem cell therapy candidate
New formulation enables expansion of Company's 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 delighted to report that the FDA has approved the
cryopreserved formulation of our human retinal progenitor cell
(hRPC) therapeutic candidate and that we have now started treating
patients with this formulation in our ongoing US Phase I/II study
clinical trial in retinitis pigmentosa (RP) patients.
The new proprietary formulation enables the hRP cells to be
frozen for shipping and storage and easily thawed at the point of
clinical use. This freeze-thaw modality provides 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 in the world.
The new hRPC formulation has also facilitated an expansion of
ReNeuron's clinical programmes in ophthalmology. As previously
announced, we will shortly file an application with the FDA to
expand the Phase II element of the ongoing Phase I/II clinical
trial in RP from six to 20 patients. The expanded study is designed
to provide the depth and quality of data that, if positive, will
allow subsequent progression to a Phase II/III pivotal study in
this indication. We also intend to file an application to start a
new US Phase II clinical trial later this year in patients with
cone-rod dystrophy, to be conducted alongside the Phase II part of
the ongoing RP clinical trial.
Olav Hellebø, Chief Executive Officer of ReNeuron, said:
"We are delighted that the FDA has approved the use of the
cryopreserved formulation of our hRPC retinal cell therapy
candidate in our ongoing clinical development programmes. This is a
further significant milestone for ReNeuron, enabling an expansion
of our clinical programmes in ophthalmology as well as providing
ReNeuron with a significant commercial advantage in terms of
prospective cost of goods and ease of use of a retinal disease
therapy."
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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