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UPDATE - ReNeuron set to launch first US clinical trial in US with eye disease stem cell treatment

Published: 23:30 13 Apr 2015 AEST

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The stem cell specialist ReNeuron (LON:RENE) has filed an investigational new drug application in the US for its potential treatment for the eye disease retinitis pigmentosa (RP).

The phase-I/II clinical trial will be its first is the States and will be conducted at Massachusetts Eye and Ear, Boston, the world-renowned clinical centre.  

It will be an open label study, which means 15 patients with advanced RP will all know they are receiving the new retinal progenitor cell therapy.

The aim of this trial is to assess safety and tolerability, as the dose is increased. Researchers will also look for early signs of efficacy. 

Retinitis pigmentosa 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.

Pre-clinical studies of ReNeuron’s cell technology suggest it has the ability to preserve existing photoreceptors, potentially reducing or even halting further deterioration of vision. 

The company’s chief executive Olav Hellebø said: “The proposed RP clinical trial initiates the company's clinical activities in the US, a very significant milestone in the development of ReNeuron as a global leader in the stem cell therapy field."

ReNeuron’s lead stem cell therapy, ReN001, is being used to treat stroke victims.

On today's news, the broker N+1 Singer said: “The trial is expected to commence in the second half of 2015, at which point the group will have three programmes in clinical development.”

The broker repeated its ‘buy’ and 6.2p price target – some way ahead of today’s share price of 3.62p. 


ReNeuron signs retinal stem cell exclusivity agreement

ReNeuron Group Plc (LON:RENE) has inked a deal worth up to US$5mln ahead of potentially licensing out its ground-breaking its hRPC retinal stem cell technology and therapeutic programmes. CFO Michael Hunt says they're hoping the exclusivity agreement with an unnamed US-based speciality...

on 11/7/18