ReNeuron Group plc Positive clinical data presented at AAO meeting (7018P)
14 October 2019 - 5:00PM
UK Regulatory
TIDMRENE
RNS Number : 7018P
ReNeuron Group plc
14 October 2019
14 October 2019 AIM: RENE
ReNeuron Group plc
("ReNeuron" or the "Company")
Positive clinical data presented at AAO meeting
Study investigator presents positive efficacy data in ongoing
retinal disease clinical trial
ReNeuron Group plc (AIM: RENE), a global leader in the
development of cell-based therapeutics, is pleased to announce that
positive efficacy data were presented during the weekend at the
American Academy of Ophthalmology Annual Meeting (AAO) in San
Francisco from the Company's Phase 1/2a clinical trial of its hRPC
stem cell therapy in retinitis pigmentosa (RP).
A copy of the presentation, by Pravin Dugel MD, an investigator
in the ongoing RP study, is available on the Company's website via
the following link:
http://www.reneuron.com/investors/presentations/
Top-line data from this presentation were announced by the
Company on 2 October 2019.
In the presentation given on Saturday 12 October 2019, Dr Dugel
discussed the strong individual improvements in vision seen in the
clinical trial and welcomed hRPC as a promising new potential
therapy for patients with RP.
Commenting on the clinical trial data, Benjamin R. Yerxa PhD,
Chief Executive Officer of the US-based non-profit organisation
Foundation Fighting Blindness, said:
"We're excited by the progress of ReNeuron's hRPC therapy. From
the Foundation's perspective, any gain in vision, or even
stabilisation, is a major step forward for patients with RP as
currently it is a condition where progressive loss of vision leads
to blindness."
Dr. Dugel's presentation reiterated that follow-up visual acuity
data from the patients treated in the Phase 2a segment of the study
continue to show the hRPC therapy's ability to deliver clinically
meaningful signals of efficacy.
From a safety perspective, according to Dr. Dugel, the clinical
trial data continue to show a good overall safety profile for the
hRPC therapy, with no immune or cell-related adverse events
reported. The isolated episodes of surgically related adverse
events are consistent with those expected for sub-retinal injection
procedures, some of which may be mitigated in the future with
technique refinements and injection site selection.
The ongoing Phase 1/2a clinical trial is an open-label study to
evaluate the safety, tolerability and preliminary efficacy of
ReNeuron's hRPC stem cell therapy candidate in patients with
advanced RP. To date, 22 patients have been treated in the study,
consisting of 12 patients in the Phase 1 segment of the study and
10 patients in the Phase 2a segment of the study. Eight out of the
10 Phase 2a patients treated have reached at least the one month
follow up time point.
The Company will continue to generate further longer-term follow
up data from the ongoing Phase 1/2a study. In parallel, the Company
will consult with its advisers and regulatory authorities in Europe
and the US in order to design and agree the future clinical
development programme for its hRPC cell therapy candidate for the
treatment of RP.
ReNeuron's RP programme has been granted Orphan Drug Designation
in both Europe and the US, as well as Fast Track designation from
the FDA.
ENDS
Contacts:
ReNeuron +44 (0) 20 3819 8400
Olav Hellebø, Chief Executive Officer
Michael Hunt, Chief Financial Officer
Buchanan (UK Media/Investor Relations) +44 (0) 20 7466 5000
Mark Court, Sophie Wills, Tilly Abraham
Argot Partners (US Media/Investor Relations)
Claudia Styslinger, David Rosen +1 212 600 1902
Stifel Nicolaus Europe Limited (NOMAD and
Joint Broker)
Jonathan Senior, Stewart Wallace, Ben Maddison +44 (0) 20 7710 7600
N+1 Singer (Joint Broker)
Aubrey Powell, James Moat, Mia Gardner +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 clinical-stage candidates are in
development for the blindness-causing disease, retinitis
pigmentosa, and for disability as a result of stroke. ReNeuron is
also advancing its proprietary exosome technology platform as a
potential delivery system for drugs that would otherwise be unable
to reach their site of action. 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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END
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