ReNeuron Group plc Clinical Update (7806L)
January 15 2021 - 2:00AM
UK Regulatory
TIDMRENE
RNS Number : 7806L
ReNeuron Group plc
15 January 2021
15 January 2021 AIM: RENE
ReNeuron Group plc
("ReNeuron" or the "Company")
Clinical update
Treatment of first patient cohort completed in Phase 2a
extension of retinal disease study
ReNeuron Group plc (AIM: RENE), a UK-based global leader in the
development of cell-based therapeutics, is pleased to provide an
update on progress with the development of its hRPC (human retinal
progenitor cell) therapy candidate for retinal diseases.
The hRPC therapeutic candidate is currently undergoing Phase 2a
clinical evaluation for the treatment of the inherited
blindness-causing disorder retinitis pigmentosa (RP). The study
uses a cryopreserved hRPC formulation, enrols subjects with
advanced RP with some remaining central vision and, thus far, has
been conducted at two clinical sites in the US.
The Company is pleased to report that dosing of the first cohort
of three subjects in the Phase 2a extension segment of the study is
now complete. This segment of the study is treating up to nine
subjects with RP at a higher dose level than the first ten subjects
already treated in the study. In line with the clinical trial
protocol, the Data Safety Monitoring Board for the study will
review short term safety data from this first cohort during the
next few weeks, before the study proceeds to dosing the next
cohort.
The Company has previously reported its intention to open the
Phase 2a study up to new sites in the US and UK, having already
received regulatory approvals to do so. The Company is pleased to
report that the latest subject dosed in the study was treated at a
new US site, the prestigious Casey Eye Institute, Oregon Health
& Science University. The Principal Investigator at this new
site is Mark Pennesi, MD, PhD, Associate Professor of
Ophthalmology, Kenneth C. Swan Endowed Professor and Chief, Paul H.
Casey Ophthalmic Genetics Division.
Dr Pennesi commented: "We are excited to enrol and treat our
first patient in the study and have high hopes regarding the
potential of this innovative new therapy for RP patients."
As well as new sites targeted in the US and UK, an additional
site in Spain is well progressed through the regulatory process.
The Company expects to open the ongoing Phase 2a study to this site
over the coming weeks.
Data from the extension segment of the Phase 2a study are
expected to be presented later this year, once all remaining
subjects have been treated. The Company anticipates that the
expanded Phase 2a study will generate sufficient data to enable it
to commence a single pivotal clinical study in the second half of
2022 with its hRPC cell therapy candidate in RP. The pivotal study
will be designed to demonstrate further the safety and efficacy of
this treatment and, assuming a successful outcome, enable ReNeuron
to seek marketing approvals for its hRPC cell therapy candidate in
RP in selected major markets.
This programme has been granted Orphan Drug Designation in both
Europe and the US, as well as Fast Track designation from the FDA
in the US. Orphan Drug Designation provides the potential for a
significant period of market exclusivity once the therapy is
approved in those territories. Fast Track designated products may
also be eligible for accelerated approval and priority review
programmes offered by the FDA.
Olav Hellebø, Chief Executive Officer of ReNeuron,
commented:
"We are extremely pleased to have completed dosing of the first
subject cohort in the extended Phase 2a clinical study with our
hRPC cell therapy candidate in RP patients. We are excited that one
of the subjects was treated at a new clinical site in the US and we
hope to add further new clinical sites shortly. The study continues
to proceed according to plan."
ENDS
Contacts:
ReNeuron +44 (0) 20 3819 8400
Olav Hellebø, Chief Executive Officer
Michael Hunt, Chief Financial Officer
info@reneuron.com
Buchanan (Media/Investor Relations) +44 (0) 20 7466 5000
Mark Court, Sophie Wills, Tilly Abraham
reneuron@buchanan.uk.com
Stifel Nicolaus Europe Limited (NOMAD and
Joint Broker)
Ben Maddison, Stewart Wallace +44 (0) 20 7710 7600
N+1 Singer (Joint Broker)
Aubrey Powell, James Moat, Tom Salvesen +44 (0) 20 7496 3000
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 cell therapy candidate is in clinical
development for the blindness-causing disease, retinitis
pigmentosa.
ReNeuron is also advancing its proprietary exosome technology
platform as a potential delivery system for drugs that treat
diseases of the brain. The Company also has the ability through its
conditionally immortalised induced pluripotent stem cell (iPSC)
platform to make any tissue cells of choice; in-house programmes
are focused on treatments for blood cancers and diabetes.
ReNeuron's shares are traded on the London AIM market under the
symbol RENE.L. For further information visit www.reneuron.com
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