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 

Ian_55ae0ddd437b7.jpg
Why Invest In ReNeuron Group Plc? Read More Here

Register here to be notified of future RENE Company articles
View full RENE profile View Profile

ReNeuron Group Plc Timeline

Newswire
February 15 2017

Related Articles

The Hydroponics Company: Access latest PPT from Proactive's CEO Sessions
May 19 2017
Dr Andrew Beehag talked medical cannabis products and pathways with investors.
Regeneus: Access latest PPT from Proactive's CEO Sessions
Sun
John Martin discussed regenerative medicine with investors.
Dimerix: Access latest PPT from Proactive's CEO Sessions
April 13 2017
Kathy Harrison talked pending milestone news with investors.

© 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