Present: Professor Martin Gore (Chair), Professor Terry Hamblin, Professor David Harrison, Mrs Debbie Beirne, Dr Adrian Lepper, Professor Andrew Baker, Professor Mary Collins, Ms Claire Foster, Professor Hilary Calvert, Dr Peter Harris, Mr Michael Harrison, Dr Stephen Minger, Professor Richard Ashcroft, Dr Michael Waterhouse, Professor Nick Lemoine and Mrs Fiona Sandford
Secretariat: Dr Monika Preuss, Mr Daniel Gooch and Miss Joanna Edwards
Observers: Dr Sharon Longhurst (MHRA), Dr Riaz Zuhrie (MHRA) and Dr Paul Logan (HSE).
Apologies: Bishop Dr Lee Rayfield, Dr Kathleen Bamford

Item 1: Welcome

The Chair welcomed the Committee to its 61st meeting.

Item 2: Minutes of the 60th meeting of GTAC

The minutes were agreed as an accurate and true record of the 60th meeting subject to a small amendment.

Item 3: Matters Arising

A number of letters had been sent out, and received, concerning correspondence arising from the last meeting, none of which gave rise to discussion.

Item 4: Chairman's Actions

Seven letters were sent out under Chairman's Actions since the last meeting. There were no substantial comments.

Item 5: GTAC and GAIC Public meeting

The Committee had a brief discussion on the very successful November public meeting.

Item 6: SUSAR Update

GTAC reviewed the new SUSARs that had been received since the previous meeting.

Item 7: Re-review GTAC 096. A Phase I Study of Adoptive Transfer of Autologous Tumour Antigen-Specific T Cells with Pre-Conditioning Chemotherapy and Intravenous IL2 in Patients with Advanced CEA Positive Tumours

This protocol was originally reviewed and approved by GTAC two years ago (November 2004) however, as recruitment has not yet started, its ethical approval had run out.

This trial will be conducted with patients who have CEA positive cancers. Carcinoembryonic antigen (CEA) is a protein that is present on the cell surface of a number of tumours including bowel, stomach and pancreatic cancer. Patients will have malignancies that are either metastatic or unsuitable for surgery, and for whom standard curative or palliative measures do not exists, or are no longer effective, or have been completed, or have been refused.

After a brief discussion the Committee re-approved this trial.

Item 8: New Protocol GTAC 128: WT1 TCR Gene Therapy of Leukaemia: A Phase I/II Safety and Toxicity Study

This is a leukaemia study for those diagnosed with AML and CML (Acute Myeloid Leukaemia and Chronic Myeloid Leukaemia).

The study proposes an immunotherapy strategy to combat the accumulation of the leukaemic blast cells that are typical for both cancers. These blast cells have on their surface a protein called Wilms Tumour Antigen 1 (WT1). The proposal is to modify T cells so that they produce WT1.

The Committee gave conditional approval for this trial.

Item 9: EMEA Consultation Document: Ethical Considerations for Clinical Trials Performed in Children.

The Committee discussed the recommendations from the EMEA for the development of implementing guidelines for the clinical trials directive (2001/20/EC) where it relates to good clinical practice of the ethical considerations that must be thought about when conducting clinical trials in children.

Item10: For Information: Eurobarometer: Europeans and Biotechnology in 2005: Patterns and Trends

The Committee briefly noted the above survey which had included information on the 'biopolitics' of gene therapy and stem cells across Europe.

Item 11: Any Other Business

Genetics White Paper
The Committee had a short discussion on the latest developments within the Department of Health regarding the Genetics White Paper vector commitment.

Resubmission of GTAC 121: An Open Label Phase I Study of CGT-A310, A Tropism Mediated Oncolytic Adenovirus, in Patients with Treatment-Refractory Metastatic Tumours
This was the resubmission of a trial discussed in July which the Committee had conditionally approved. Professor Nick Lemoine briefly addressed the Committee with a summary of the changes before leaving the room with a declared interest.

The Committee discussed the proposed changes to the trial with a view to providing feedback to the proposers

Professor Nick Lemoine returned to the meeting.

Amendment to GTAC 66
The Committee had a short discussion of this amendment before giving approval.

Item 12: Press Cuttings
There was no discussion of the press cuttings.

NEXT MEETING: Wednesday, 21 February 2007, Wellington House

GTAC Secretariat

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