TIDMRENE
RNS Number : 4279O
ReNeuron Group plc
02 October 2019
2 October 2019 AIM: RENE
ReNeuron Group plc
("ReNeuron" or the "Company")
Clinical update and conference presentations
"Clear efficacy signal" in Phase 2a study of hRPC cell therapy
in retinitis pigmentosa
ReNeuron Group plc (AIM: RENE), a global leader in the
development of cell-based therapeutics, is pleased to announce new
positive data in the Company's ongoing Phase 1/2a clinical trial of
its human retinal progenitor cell (hRPC) therapy candidate in the
blindness-causing disease, retinitis pigmentosa (RP).
At most recent follow-up in the Phase 2a segment of the study,
the mean improvements from baseline in visual acuity as measured by
the number of letters read on the ETDRS chart (the standardised eye
chart used to measure visual acuity in clinical trials) were as
follows:
Months post-treatment Mean improvement Mean improvement Mean change in
in visual acuity in visual acuity visual acuity
in treated eye in treated eye in untreated
(excluding two eye
patients with procedure-related
vision loss)
1 +8.3 letters +14.5 letters (n=6) + 1.6 letters
(n=8) (n=8)
------------------ --------------------------------- ---------------
2 +5.4 letters +13.0 letters (n=6) + 2.8 letters
(n=8) (n=8)
------------------ --------------------------------- ---------------
3 +6.1 letters +17.8 letters (n=6) + 6.8 letters
(n=8) (n=8)
------------------ --------------------------------- ---------------
6 +18.5 letters +28.7 letters (n=3) + 7.8 letters
(n=4) (n=4)
------------------ --------------------------------- ---------------
9 +12.0 letters +12.0 letters (n=1) - 1.0 letter
(n=1) (n=1)
------------------ --------------------------------- ---------------
The observed efficacy was rapid and profound in the first three
patients in the Phase 2a segment of the study. Efficacy in
subsequent patients has also been seen but at a lower rate and
magnitude (improvement in visual acuity ranging from +5 to +11
letters in the treated eye 3 months post-treatment), with the
ultimate extent of improvement not yet known as the study is
ongoing. Overall, the improvements to date represent a clear signal
of efficacy in a patient population where inexorable disease
progression is the norm.
A total of 22 patients have now been treated in the Phase 1/2a
study and a good safety profile has been established, with no
patients experiencing product-related serious adverse events and
two patients experiencing surgical procedure-related loss of
vision.
These latest results will be presented in further detail by
Pravin Dugel MD, Managing Partner, Retinal Consultants of Arizona,
Phoenix, Arizona, and Clinical Professor, Roski Eye Institute, USC
Keck School of Medicine, Los Angeles, California, at the American
Academy of Ophthalmology Annual Meeting (AAO) in San Francisco,
taking place on 12-15 October 2019. Dr Dugel will present in a Late
Breaking Developments session at the meeting on 12 October
2019.
Olav Hellebø, Chief Executive Officer of ReNeuron, will give a
presentation in the Gene and Cell Therapy Spotlight session during
the Ophthalmology Innovation Summit (OIS@AAO) on 10 October 2019,
preceding the AAO meeting.
Dr. Pravin Dugel commented:
"I am looking forward to presenting and discussing these
encouraging data at the upcoming AAO meeting in San Francisco. I
believe that we are seeing a clear signal of efficacy in this
patient population where any gain in vision, let alone the levels
seen in some of these patients, is so hard to come by and so very
much appreciated."
RP is a group of hereditary diseases of the eye that lead to
progressive loss of sight due to cells in the retina becoming
damaged and eventually dying. The Company's RP clinical programme
has been granted Orphan Drug Designation in both Europe and the US,
as well as Fast Track designation from the FDA.
The 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. The
Phase 2a segment of the study, which uses a cryopreserved hRPC
formulation, enrols subjects with some remaining retinal function
and is being conducted at two clinical sites in the U.S. --
Massachusetts Eye and Ear in Boston and Retinal Research Institute
in Phoenix, Arizona.
ReNeuron's hRPC cell therapy candidate offers a number of
potential advantages over alternative approaches to the treatment
of RP. Firstly, the cell therapy candidate is independent of the
many specific genetic defects that collectively define RP as a
disease, thereby allowing a much broader potential patient
population to be eligible for the treatment. Secondly, the cells
are cryopreserved, enabling on-demand shipment and use at local
surgeries and hospitals. Finally, the cells are injected directly
to the site of retinal degeneration, allowing a greater chance of
anatomic restoration of photoreceptor function.
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.
Olav Hellebø, Chief Executive Officer of ReNeuron,
commented:
"We are greatly encouraged by the latest efficacy data from the
ongoing Phase 1/2a clinical study of our hRPC cell therapy
candidate in patients with RP. It is especially gratifying to see
positive data given the inherent challenge in addressing a disease
as complex as RP and we look forward to further progressing the
clinical development of this promising cell therapy candidate."
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.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
RESCKDDQKBDBKKK
(END) Dow Jones Newswires
October 02, 2019 02:00 ET (06:00 GMT)
Reneuron (LSE:RENE)
Historical Stock Chart
From Apr 2024 to May 2024
Reneuron (LSE:RENE)
Historical Stock Chart
From May 2023 to May 2024