Corporate Banner
Satellite Banner
Stem Cells, Cellular Therapy & Biobanking
>
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

ReNeuron Receives European and US Orphan Drug Designation

Published: Friday, August 30, 2013
Last Updated: Friday, August 30, 2013
Bookmark and Share
Company has received Orphan Drug Designation for its ReN003 stem cell therapy candidate for retinitis pigmentosa.

ReNeuron Group plc has announced that its ReN003 retinal stem cell therapy candidate for retinitis pigmentosa has achieved a significant regulatory milestone.

The therapy has been granted Orphan Drug Designation in both Europe and the US by the European Commission and the Food and Drug Administration, respectively.

Orphan Drug Designation is typically granted to treatments that provide significant benefit to patients with rare diseases that are life-threatening or chronically debilitating.

Treatments with this designation benefit from significant commercial and regulatory advantages such as market exclusivity for 10 years from approval in the disease concerned, against other treatments offering no greater therapeutic advantage.

ReNeuron is using its proprietary human retinal progenitor cells as the basis of its ReN003 therapeutic candidate targeting retinitis pigmentosa, 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.

Retinitis pigmentosa affects approximately 4 in 10,000 people in the EU and US.

The late pre-clinical development of the ReN003 programme also benefits from a recently awarded £0.8 million Biomedical Catalyst grant from the UK Technology Strategy Board.

The Company is targeting an initial Phase I/II clinical trial with ReN003 in the UK and the US, in retinitis pigmentosa patients, with clinical trial applications expected to be filed in the middle part of 2014.

Michael Hunt, Chief Executive Officer of ReNeuron, said: “We are delighted to have received Orphan Drug Designation for our ReN003 stem cell therapy candidate for retinitis pigmentosa from both the European Commission in Europe and the FDA in the US. Orphan status diseases are an increasing area of therapeutic and commercial focus by the mainstream pharmaceutical industry due to the distinct regulatory and market exclusivity advantages that Orphan Drug Designation confers. This fact bodes well for the commercial potential of our ReN003 therapy.”


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,000+ scientific posters on ePosters
  • More than 4,500+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Publication of Pre-Clinical Data Relating to ReNeuron’s Exosome Nanomedicine Platform
Data support the potential use of ReNeuron’s exosomes as therapeutic agents and as a delivery system in gene therapy.
Tuesday, January 12, 2016
Non-executive Director Appointment
Company announces appointment of Dr Mike Owen.
Saturday, December 05, 2015
AGM Trading Update
CTX stem cell therapy candidate currently in a UK Phase II clinical trial.
Friday, September 25, 2015
Preliminary Results for the Year Ended 31 March 2015
Appointment of Olav Hellebø as CEO.
Saturday, July 11, 2015
ReNeuron Announces Research Collaboration with Benitec Biopharma
Collaboration using exosomes as delivery system for gene silencing in cancer therapy.
Tuesday, June 23, 2015
FDA Grants Fast Track Designation to ReNeuron’s RP Cell Therapy Candidate
Approval to commence a Phase I/II clinical trial in the US with stem cell therapy candidate for RP.
Saturday, May 23, 2015
Long Term Clinical Data from PISCES Stroke Trial
Long term data continue to show good safety profile and evidence of sustained improvements in neurological status and limb function.
Saturday, April 18, 2015
ReNeuron Files Application to Commence Phase I/II Clinical Trial in the US
IND application to commence clinical trial for retinitis pigmentosa with hRPC therapy candidate.
Tuesday, April 14, 2015
ReNeuron Reconfigures Board
Company further strengthens executive management for next phase of development.
Wednesday, April 08, 2015
ReNeuron Announces Appointment of Chief Executive Officer
Company appoints Olav Hellebø as new CEO.
Tuesday, September 09, 2014
ReNeuron AGM Trading Update
Results from the Phase I study with ReN009 announced in the first half of 2015.
Tuesday, September 09, 2014
ReNeuron Receives UK Regulatory Approvals
Company receive approvals to commence Phase II clinical trial in stroke and Phase I clinical trial in critical limb ischaemia.
Friday, March 28, 2014
ReNeuron to Receive Support from Foundation Fighting Blindness
Company receive support for its ReN003 retinal stem cell therapy candidate for treatment of retinitis pigmentosa.
Wednesday, March 12, 2014
ReNeuron Announces £33 Million Financing Package
Placing to raise up to £25.35 million, grant package of £7.8 million from Welsh Government and Notice of General Meeting.
Monday, July 22, 2013
ReNeuron Signs License Agreement with Leading US Eye Research Institute to Develop Stem Cell Therapies for Diseases of the Retina
ReNeuron has been collaborating with Schepens in the early development of its human retinal precursor cells (hRPCs).
Monday, June 20, 2011
Scientific News
Turning Skin Cells into Heart, Brain Cells
In a major breakthrough, scientists at the Gladstone Institutes transformed skin cells into heart cells and brain cells using a combination of chemicals.
Stem Cells Know How to Unwind
Research led by the Babraham Institute with collaborators in the UK, Canada and Japan has revealed a new understanding of how an open genome structure supports the long-term and unrestricted developmental potential in embryonic stem cells.
Growing Stem Cells More Safely
Nurturing stem cells atop a bed of mouse cells works well, but is a non-starter for transplants to patients – Brown University scientists are developing a synthetic bed instead.
Cell Transplant Treats Parkinson’s in Mice
A University of Wisconsin—Madison neuroscientist has inserted a genetic switch into nerve cells so a patient can alter their activity by taking designer drugs that would not affect any other cell.
Skin Cells Turned into Heart Cells and Brain Cells Using Drugs
In a scientific first, Gladstone researchers have used chemical drugs to convert skin cells into heart cells and brain cells, without adding any external genes.
Shape Of Tumor May Affect Whether Cells Can Metastasize
Illinois researchers found that the shape of a tumor may play a role in how cancer cells become primed to spread.
‘Mini-Brains’ to Study Zika
Novel tool expected to speed research on brain and drug development.
Cytokine Triggers Immune Response at Expense of Blood Renewal
Research highlights promise of Anti-IL-1 drugs to treat chronic inflammatory disease.
AstraZeneca to Sequence 2 Million Genomes in Search for New Drugs
Company launches integrated genomics approach which aims to transform drug discovery and development.
Improving Engineered T-Cell Cancer Treatment
Purdue University researchers may have figured out a way to call off a cancer cell assassin that sometimes goes rogue and assign it a larger tumor-specific "hit list."
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!