(Alliance News) - ReNeuron Group PLC on Monday said long-term data from the ongoing clinical trial of its hRPC stem cell therapy candidate has been positive, and it now plans to expand the study.
ReNeuron's hRPC stem cell therapy candidate is intended to treat retinitis pigmentosa, a group of hereditary eye diseases which cause progressive sight loss and blindness. A phase 1/2a trial is ongoing.
Back in October, positive interim efficacy date from patients in the phase 2a trial segment showed that "a group of subjects who had had a successful surgical procedure with sustained clinically relevant improvements in visual acuity compared with baseline", as measured by the number of letters read on a standard eye chart.
Since then, long-term efficacy data showed a continued "meaningful clinical effect from the therapy at all time points out to twelve months post-treatment".
At 12 months after treatment, the mean change from baseline in visual acuity in the treated eye was 14.3 letters for those patients with a successful surgical procedure.
ReNeuron is requesting US Food & Drug Administration approval to expand the study to treat another nine patients in the phase 2a trial segment with a dose of two million hRPC cells, up from one million in the study so far.
"The amended clinical trial protocol also allows for a greater range of pre-treatment baseline visual acuity in patients and includes changes that enhance the ability to use microperimetry testing to measure and detect changes in retinal sensitivity in patients treated," ReNeuron said.
ReNEuron has also applied to the UK's Medicines & Healthcare products Regulatory Agency to open the ongoing trial to clinical site in the UK.
ReNeuron Chief Executive Olav Hellebo said: "We remain greatly encouraged by the data from the Phase 1/2a clinical study of our hRPC cell therapy candidate in patients with [retinitis pigmentosa]. The longer-term follow-up data are particularly noteworthy, demonstrating that the therapy appears to maintain its beneficial effects out to at least one year post-treatment."
Shares in ReNeuron were up 1.8% at 145.00 pence in London on Monday.
By Anna Farley; annafarley@alliancenews.com
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