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Montag, 29.06.2020 22:05 von | Aufrufe: 93

ReNeuron Announces Further Positive Data in Retinal Clinical Trial

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PR Newswire

LONDON, June 29, 2020 /PRNewswire/ -- ReNeuron Group plc (AIM:RENE), a global leader in the development of cell-based therapeutics, is pleased to announce further positive long-term data from the ongoing Phase 2a clinical trial of its hRPC stem cell therapy candidate in retinitis pigmentosa (RP).  RP is a group of hereditary diseases of the eye that lead to progressive loss of sight and ultimately blindness.

On February 24, 2020, positive interim efficacy data from patients treated in the Phase 2a study were announced by the Company.  The data continued to show a meaningful clinical effect from the therapy at all time-points out to twelve months post-treatment, as measured by the number of letters read on the ETDRS chart (the standardised eye chart used to measure visual acuity in clinical trials). 

Since those results were announced, further long-term data from the study have been gathered from patients at six, nine, twelve and now, for the first patient treated, eighteen months follow-up.  The Company is pleased to report that the latest data continue to demonstrate the efficacy of the therapy, with a clinically meaningful benefit being observed at all time-points.  These results are particularly encouraging as RP is characterized by inexorable progression to blindness, with no therapy currently available for the vast majority of patients.

The results announced on February 24, 2020 excluded two subjects who experienced sight loss as a result of complications arising from the surgical procedure.  The Company is pleased to report that one of these two patients has now recovered their vision and is back to at least baseline at one year post treatment.

As previously reported, the degree of efficacy observed varies between patients, with the latest mean results set out in the tables below.  The first table shows the latest data including the above-mentioned patient who has recovered to at least the baseline level of vision in the treated eye.  The second table shows the latest data excluding both of the patients who originally experienced surgical complications, to provide a comparison against the data previously announced on February 24, 2020.

Months post-treatment

Mean change from baseline in visual acuity in treated eye*


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Mean change from baseline in visual acuity in untreated eye*

Difference in mean change between treated eye and untreated eye*

1

  +7.9 letters (n=9)

+0.2 (n=9)

   +7.7 (n=9)

2

  +8.0 letters (n=9)

+1.2 (n=9)

   +6.8 (n=9)

3

+10.8 letters (n=9)

+4.4 (n=9)

   +6.4 (n=9)

6

  +9.6 letters (n=9)

+3.4 (n=9)

   +6.2 (n=9)

9

  +7.1 letters (n=8)

+1.2 (n=8)

   +5.9 (n=8)

12

+11.9 letters (n=5)

+4.3 (n=5)

   +7.6 (n=5)

18

+17.0 letters (n=1)

+1.0 (n=1)

 +16.0 (n=1)

* Excluding one patient who experienced surgical complications

Months post-treatment

Mean change from baseline in visual acuity in treated eye*

Mean change from baseline in visual acuity in untreated eye*

Difference in mean change between treated eye and untreated eye*

1

  +11.4 letters (n=8)

+0.3 (n=8)

 +11.1 (n=8)

2

  +10.8 letters (n=8)

+1.6 (n=8)

   +9.2 (n=8)

3

  +14.0 letters (n=8)

+5.1 (n=8)

   +8.9 (n=8)

6

  +12.3 letters (n=8)

+3.4 (n=8)

   +8.9 (n=8)

9

  +11.8 letters (n=7)

+1.2 (n=7)

 +10.6 (n=7)

12

  +13.4 letters (n=4)

+4.6 (n=4)

   +8.8 (n=4)

18

  +17.0 letters (n=1)

+1.0 (n=1)

 +16.0 (n=1)

* Excluding both patients who originally experienced surgical complications

The equivalent data set announced by the Company on February 24, 2020 is as follows:

Months post-treatment

Mean change from baseline in visual acuity in treated eye*

Mean change from baseline in visual acuity in untreated eye*

Difference in mean change between treated eye and untreated eye*

1

+11.4 letters (n=8)

+0.3 (n=8)

+11.1 (n=8)

2

+10.8 letters (n=8)

+1.6 (n=8)

  +9.2 (n=8)

3

+14.0 letters (n=8)

+5.1 (n=8)

  +8.9 (n=8)

6

+15.7 letters (n=6)

+6.5 (n=6)

  +9.2 (n=6)

9

+16.5 letters (n=4)

+6.0 (n=4)

+10.5 (n=4)

12

+14.3 letters (n=3)

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