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- The Consortium is formed on the initiative of the Cystic Fibrosis Trust.
- Reorganisation of the three groups and creation of specific working groups and core facilities at each of the three sites.
- 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.
- End of product evaluation.
- GL67A selected as gene transfer agents (GTAs) for clinical studies.
- 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.
- 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.
- Single Dose Clinical Trial (Pilot study) commences.
- Extensive pre-clinical multi-dose toxicology studies commence (these are required by law ahead of multi-dose studies in CF patients).
- Completion of Single Dose Clinical Trial (Pilot study).
- Extensive pre-clinical multi-dose toxicology studies completed.
- 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.
- End of multi-dose Clinical trial.
2015 - Proposed
- Publication of the clinical trial results
Monday, September 1st 2014