03:00 Wed 02 Oct 2019
ReNeuron Group plc - Clinical Update and Conference Presentations
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AIM: RENE |
ReNeuron Group plc
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Clinical update and conference presentations
"Clear efficacy signal" in Phase 2a study of hRPC cell therapy in retinitis pigmentosa
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 in visual acuity in treated eye |
Mean improvement in visual acuity in treated eye (excluding two patients with procedure-related vision loss) |
Mean change in visual acuity in untreated eye |
1 |
+8.3 letters (n=8) |
+14.5 letters (n=6) |
+ 1.6 letters (n=8) |
2 |
+5.4 letters (n=8) |
+13.0 letters (n=6) |
+ 2.8 letters (n=8) |
3 |
+6.1 letters (n=8) |
+17.8 letters (n=6) |
+ 6.8 letters (n=8) |
6 |
+18.5 letters (n=4) |
+28.7 letters (n=3) |
+ 7.8 letters (n=4) |
9 |
+12.0 letters (n=1) |
+12.0 letters (n=1) |
- 1.0 letter (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
Dr.
"I am looking forward to presenting and discussing these encouraging data at the upcoming AAO meeting in
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
The Phase 1/2a clinical trial is an open-label study to evaluate the safety, tolerability and preliminary efficacy of
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
"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 |
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Michael Hunt, Chief Financial Officer |
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Buchanan (UK Media/Investor Relations) |
+44 (0) 20 7466 5000 |
Mark Court, Sophie Wills, Tilly Abraham |
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Claudia Styslinger, David Rosen |
+1 212 600 1902 |
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Jonathan Senior, Stewart Wallace, Ben Maddison |
+44 (0) 20 7710 7600
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N+1 Singer (Joint Broker) Aubrey Powell, James Moat, Mia Gardner |
+44 (0) 20 7496 3000 |
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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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