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

 

DNA fragments being cut from an agarose gel exposed to UV.

 

A CFTR Western blot, to confirm protein production in cell culture.

 

A pellet of E.coli containing a plasmid expressing a pink fluorescent protein.

 

Human airway liquid interface cultures transduced with a lentivirus expressing Luciferase.

 

Large scale lentivirus production in suspension culture.