LONDON, Oct. 14, 2019 /PRNewswire/ -- 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). Top-line
data from this presentation were announced by the Company on
October 2, 2019.
A copy of the presentation, by Pravin
Dugel M.D., an investigator in the ongoing RP study, is
available on the Company's website via the following link:
http://www.reneuron.com/investors/presentations/
In the presentation given on Saturday,
October 12, 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.
"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," commented Benjamin R. Yerxa PhD, Chief Executive
Officer of the US-based non-profit organisation Foundation Fighting
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 U.S. in order to
design and agree on the future clinical development program for its
hRPC cell therapy candidate for the treatment of RP.
ReNeuron's RP program has been granted Orphan Drug Designation
in both Europe and the U.S., as
well as Fast Track designation from the FDA.
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.
View original
content:http://www.prnewswire.com/news-releases/reneuron-presents-positive-clinical-data-at-the-american-academy-of-ophthalmology-annual-meeting-300937604.html
SOURCE ReNeuron Group plc