ReNeuron makes progress with hRPC trials
Posted on: Friday, November 3rd, 2017
ReNeuron said its hRPC clinical trial’s data safety monitoring board has given approval for the study to progress into its Phase II element. That decision was said to be based on short term data from the nine RP patients treated in the Phase I part of the study, which indicated that the hRPC cell therapy was “safe and well tolerated” at the three doses tested.
The final high-dose cohort of patients in the Phase I part of the study was treated with the newly-developed cryopreserved formulation of the company’s hRPC cell therapy candidate, the board added. It said that, based on the short term safety data, that was the formulation and dose that would be utilised in the Phase II element of the study.
That part of the study would recruit six RP patients with less impaired vision than those treated in the Phase I element, and would lead to a larger, placebo-controlled Phase IIb clinical trial in similar patients in terms of the progression of their disease.
The company said it expected readouts from the Phase II part of the ongoing RP clinical trial in the second half of 2018, with efficacy data from a subsequent, larger Phase IIb study in 2020. As it previously announced, ReNeuron also intended to seek approval to commence a Phase II clinical trial with its hRPC cell therapy candidate in patients with cone-rod dystrophy (CRD) to run concurrently with the Phase IIb testing of this candidate in RP.
It described CRD as a group of rare eye disorders associated with a loss of cone cells in the retina, that results in deterioration of central visual acuity and colour vision.
“We are delighted that the data safety monitoring board has given its approval to progress our ongoing clinical trial in retinitis pigmentosa into its Phase II element,” said ReNeuron CEO Olav Hellebø.
“Our hRPC cell therapy candidate offers the potential for an entirely new therapeutic option for patients suffering from diseases of the retina such as retinitis pigmentosa and cone-rod dystrophy, and represents a therapeutic platform technology with high commercial potential for ReNeuron.”