Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
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 3,200+ scientific posters on ePosters
  • More Than 4,700+ 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

ReNeuron Announces First Patient Treated in US Phase I/II Clinical Trial
Company has announced that the first patient has been treated with the Company’s cell therapy candidate for the blindness causing disease RP in a first-in-human US clinical trial.
Thursday, March 17, 2016
ReNeuron Receives Notice of Grant of Key US Patent on its Cell Cryopreservation Technology
Company has announced that it has received a notice of allowance for a key patent application covering its cell cryopreservation technology.
Tuesday, February 09, 2016
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
Further Data from First Clinical Trial of ReNeuron’s Stem Cell Therapy to be Presented at Stroke Conference
Long term data continue to show good safety profile and evidence of sustained reductions in neurological impairment and spasticity.
Friday, May 16, 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
Scientific News
Open Source Seed Initiative – A Welcome Boost to Global Crop Breeding
A team of plant breeders, farmers, non-profit agencies, seed advocates, and policymakers have created the Open Source Seed Initiative.
ASMS 2016: Targeting Mass Spectrometry Tools for the Masses
The expanding application range of MS in life sciences, food, energy, and health sciences research was highlighted at this year's ASMS meeting in San Antonio, Texas.
Benchtop Automation Trends
Gain a better understanding of current interest in and future deployment of benchtop automated systems.
Anthrax Proteins Might Help Treat Cancerous Tumors
Studies in mice reveal novel treatment regimen.
New Cancer Drug Target Found in Dual-Function Protein
Findings from a study from TSRI have shown that targeting a protein called GlyRS might help to halt cancer growth.
Key to Chronic Fatigue Syndrome is in Your Gut, Not Head
Researchers report they have identified biological markers of the disease in gut bacteria and inflammatory microbial agents in the blood.
HIV Structure Stabilized
Findings represent ‘big accomplishment’ in biomedical engineering and design.
Four Newly-Identified Genes Could Improve Rice
A Japanese research team have applied a method used in human genetic analysis to rice and rapidly discovered four new genes that are potentially significant for agriculture. These findings could influence crop breeding and help combat food shortages caused by a growing population.
New Cancer Drug Target in Dual-Function Protein
Scientists at The Scripps Research Institute (TSRI) have identified a protein that launches cancer growth and appears to contribute to higher mortality in breast cancer patients.
Antibodies To Dengue May Alter Course Of Zika Virus Infection
Scientists at Emory Vaccine Center, in collaboration with investigators from Thailand, have found that people infected with dengue virus develop antibodies that cross-react with Zika virus.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
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
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!