Sign up UNITED KINGDOM
Proactive Investors - Run By Investors For Investors

ReNeuron set the broaden scope of eye disease research after regulatory sign-off for frozen cell line

The US Food & Drug Administration (FDA) green light means its human retinal progenitor cells (hRPC) can be frozen for shipping and storage and thawed at the point of use.
ReNeuron set the broaden scope of eye disease research after regulatory sign-off for frozen cell line
The cells can be specially frozen for transportation and thawed when needed

The American regulator has approved a cryopreserved formulation of ReNeuron Group Plc’s (LON:RENE) cell therapy for degenerative diseases of the retina.

The US Food & Drug Administration (FDA) green light means its human retinal progenitor cells (hRPC) can be frozen for shipping and storage and thawed at the point of use. 

“This is a further significant milestone for ReNeuron, enabling an expansion of our clinical programmes in ophthalmology as well as providing ReNeuron with a significant commercial advantage in terms of prospective cost of goods and ease of use of a retinal disease therapy," said chief executive Olav Hellebø.

Clinical programme to expand

Researchers have started treating patients with the new formulation in a US phase-I/II study clinical trial in patients with retinitis pigmentosa, a degenerative eye disease.

As mentioned above the new cryopreserved formulation will allow an expansion of ReNeuron's clinical programmes in ophthalmology. 

The firm will shortly file an application with the FDA to expand the phase-II element of the ongoing phase-I/II clinical trial in retinitis pigmentosa from six to 20 patients. 

This is designed to provide the depth and quality of data that, if positive, will allow progression to a phase-II/III pivotal study.

ReNeuron will also file an application to start a new US phase-II clinical trial later this year in patients with cone-rod dystrophy (another degenerative eye condition), to be conducted alongside the phase-II part of the ongoing retinitis pigmentosa clinical trial.

WATCH: Our last chat with ReNeuron 

View full RENE profile View Profile

ReNeuron Group Plc Timeline

Related Articles

Knee surgery
February 02 2017
The treatment involves removing cellular material from animal and human tissue to leave a matrix which gives a framework for population by the patient’s own cells.
generic pill and bottle shot to denote Alliance's products
August 14 2017
The company has made the transition from a business capitalised at £90mln to company now worth around a quarter of a billion pounds - but has the market at large picked up on (and priced in) the transformation?
eye-766166_1280_583251a48f148.jpg
November 21 2016
The flagship product, CardioCel, is a bio-engineered tissue scaffold used in the heart valve repair market.

© Proactive Investors 2017

Proactive Investor UK Limited, trading as “Proactiveinvestors United Kingdom”, is Authorised and regulated by the Financial Conduct Authority.
Registered in England with Company Registration number 05639690. Group VAT registration number 872070825 FCA Registration number 559082. You can contact us here.

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use