ReNeuron Group begins dosing second cohort in hRPC study
By Josh White
Date: Monday 18 Mar 2019
(Sharecast News) - Cell-based therapeutics company ReNeuron Group updated the market on progress with the ongoing phase 1 and 2 clinical trial in the US of its 'hRPC' cell therapy candidate in the blindness-causing disease, retinitis pigmentosa (RP).
The AIM-traded firm reported that, following a positive data safety monitoring board review of the clinical data from the first phase 2 patient cohort in the study, dosing of the second cohort of three phase 2 subjects had now begun, with the first subject in the cohort treated last week at Massachusetts Eye and Ear in Boston.
It said the next dose cohort comprised patients who had a greater baseline level of visual acuity than those treated in the study thus far, providing a framework to better evaluate the safety of the treatment and to gain further clarity on the strong efficacy signal that was seen in the first phase 2 cohort.
Last month, ReNeuron reported that all three of the first cohort of subjects in the phase 2 part of the study had reported a "rapid and significant" improvement in vision, on average equivalent to reading an additional three lines of five letters on the EDTRS eye chart - the standardised eye chart used in clinical trials to measure visual acuity.
The company's RP clinical programme benefited from orphan drug designation in both Europe and the US, as well as 'fast track' designation from the FDA.
As it had previously reported, the company expected to report further short term readouts in mid-2019 from the ongoing study.
"We remain extremely encouraged by the positive efficacy data we have seen thus far in the phase 1 and 2 study with our hRPC cell therapy candidate in RP patients," said ReNeuron Group chief executive officer Olav Hellebø.
"These results have already attracted considerable interest, particularly from those in the ophthalmology field, and we look forward to reporting further results from the study as it progresses over the coming months."
As at 1135 GMT, shares in ReNeuron Group were up 6.41% at 74.49p.
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