Consortium Timeline

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Consortium publication on the cover of Molecular Therapy, February 2002.

2001

  • The Consortium is formed on the initiative of the Cystic Fibrosis Trust.

 

2002-2003

  • Reorganisation of the three groups and creation of specific working groups and core facilities at each of the three sites.

 

2004

  • Development of the first CpG-Free plasmids.
  • Start of the product evaluation study to assess the effectiveness of multiple gene transfer agents (GTAs) in pre-clinical studies.The clinical trial plasmid pGM169

 

2005

  • End of product evaluation.
  • GL67A selected as gene transfer agents (GTAs) for clinical studies.

 

2006

  • Tracking Study commences.
  • Creation of a modular clinical plasmid design (after extensive plasmid development).
  • hCEFI promoter established as having superior duration of expression in pre-clinical models (after multiple promoter elements are tested).
  • The clinical trial plasmid pGM169 produced in Oxford.

 

2007

  • Completion of the Tracking Study.
  • Commercial manufacturing of GL67A and pGM169 begins.
  • Testing and selection of clinical nebulisers.
  • Extensive clinical assay development ahead of clinical studies.
  • Design of a mixing device for correct mixing of GL67A and pGM169.The clinical trial mixing device

 

2008

  • Run-in Study commences.

 

2009

  • Single Dose Clinical Trial (Pilot study) commences.

 

2010

  • Extensive pre-clinical multi-dose toxicology studies commence (these are required by law ahead of multi-dose studies in CF patients).

 

2011

  • Completion of Single Dose Clinical Trial (Pilot study).
  • Extensive pre-clinical multi-dose toxicology studies completed.Nebuliser

 

2012

  • CF Trust withdraws funding from the Consortium (limited funding provided to March 2012).
  • Consortium awarded grants from the MRC & NIHR to continue clinical trial and research programmes.
  • Start of multi-dose Clinical trial to assess efficacy of GL67/pGM169 formulation.
  • Rosie Barnes launches Just Gene Therapy to raise funds for the Consortium.

 

2014

  • End of multi-dose Clinical trial.

 

2015 - Proposed

  • Publication of the clinical trial results

Monday, September 1st 2014

 

Proposed 3D model of the CFTR protein.

 

Purifying mRNA from tissue samples.

 

Large scale lentivirus production in suspension culture.

 

E.coli from a large scale industrial production of our clinical trial plasmid pGM169.

 

A frozen vial of GL67A (left) and a frozen vial of pGM169 plasmid DNA (right)