Consortium Milestones Towards our Clinical Study Programme

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2001

Consortium formed on the initiative of the CF 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 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 GTA for clinical studies. Download

2006

Further extensive plasmid development leads to the creation of a modular clinical plasmid design.

Multiple promoter elements are tested and the hCEFI promoter established as having superior duration of expression in pre-clinical models.

The clinical trial plasmid pGM169 produced in Oxford.

2007

Final pre-clinical studies.

Commercial manufacturing of GL67A and pGM169 begins.

Patient recruitment starts.

Testing and selection of clinical nebulisers.

Extensive clinical assay development ahead of clinical studies.

2008

Start of the single dose safety study in CF patients at the Brompton Hospital.

2009-2011

Ongoing single dose safety study.

Over 40 patients enrolled in single dose study by mid 2011.

Extensive pre-clinical multi-dose toxicology studies conducted as required by law ahead of multi-dose studies in CF patients. These studies last around 1 year each and use formulations of the same standard (and cost) as the clinical trial itself.

Recruitment of patients for the multi-dose study at the Brompton Hospital and Western General, Edinburgh.

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2012

Start of multi-dose clinical study to assess efficacy of GL67/pGM169 formulation.

2013

End of MD clinical trial towards the end of 2013.

 

 

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