Consortium Timeline

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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.

 

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.

 

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.

 

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