Present: Professor Norman C Nevin (Chair), Ms Caroline Benjamin, Mrs Debbie Beirne, Professor Martin Gore, Professor Terry Hamblin, Dr Peter Harris, Professor David Harrison, Mr Michael Harrison, Professor Nick Lemoine, Professor Andrew Lever, Professor Alex Markham, Professor James Neil, Reverend Dr Lee Rayfield, Mrs Fiona Sandford, Dr Michael Waterhouse.

Observers: Dr Philip Harrison (MCA), Mr Michael Macket (HSE), Dr Monika Preuss.

Secretariat: Dr Jayne Spink, Mrs Margaret Straughan, Mr Daniel Gooch.

Item 1. Welcome and Apologies.

The Chair welcomed Members to the 41^st Meeting of GTAC. The Chair also welcomed Dr Monika Preuss who joins the committee as an observer. She will take up her post in the Secretariat in April. Apologies had been received from Mr David Crosby.

Item 2. Minutes of the 40^th Meeting of GTAC.

With a few minor amendments these were accepted as a true and accurate record.

Item 3. Matters Arising.

The 8^th Annual Report had been published on Friday, 31^st January 2003.

Members had been provided with a letter from Lord Hunt in which the Minister agreed that GTAC should be recognised as the UK wide research ethics committee (MREC) for all gene therapy trials under the new regulations. Until these regulations come into force, GTAC will continue to function as the national gene therapy REC.

A supplementary pack of papers concerning issues of retroviral safety had been tabled. These papers concerned the forthcoming joint CSM/GTAC working group.

Next, the correspondence arising from the 40^th Meeting was discussed. These were noted by GTAC.

Item 4. Protocol: Phase I clinical gene therapy protocol for X-SCID (request for the use of umbilical cord blood). Great Ormond Street Hospital.

Members' were informed that this proposal should be considered in light of the current restrictions placed on X-SCID trials. Prior to discussing the proposal, the proposers gave a presentation to update Members on the X-SCID severe adverse events in France and to provide an update on the status of their own patients, the patients' progress and any other information that may be relevant.

The proposal is an application to harvest the affected child's umbilical cord blood and modify blood stem cells with the vector construct where a diagnosis for X-SCID has been made in utero. After a short presentation by the proposers and discussion by Members, it was agreed that this protocol should be given conditional approval in principle. This was subject to some minor amendments, subject to the current restrictions placed on the X-SCID study and subject to parents' receiving independent counselling from a clinical geneticist and/or independent paediatric immunologist prior to trial specific counselling.

Item 5. Protocol: Gene therapy protocol for the evaluation of the safety and efficacy of TroVax in conjunction with chemotherapy in patients with metastatic colorectal cancer. Christie Hospital, Manchester

The use of the study product was originally considered in July 2000 and approval was granted in October 2000. TroVax is based on a modified Vaccinia Ankara Virus. Data from the original study had been supplied to the Committee. After a short presentation by the proposers and discussion by Members, it was agreed to give conditional approval subject to minor amendments.

Item 6. Protocol: A double-blind placebo controlled randomised phase I study of NYVAC C in healthy volunteers at low risk of HIV infection. St Mary's Hospital, London.

GTAC has previously approved 2 gene therapy studies for HIV/AIDS in infected patients and accepted 2 notifications for healthy volunteer studies. After a short presentation by the proposers and discussion by Members, it was agreed to give conditional approval subject to appropriate amendments and clarification of the patient information leaflet and consent forms.

Item 7. Protocol: A phase I/II study of DNA vaccination with a CEA/pDOM fusion gene in patients with carcinomas expressing CEA. Southampton General Hospital.

This protocol proposes to immunise cancer patients with a DNA vaccine. It is hoped that the immune system will recognise and destroy cancer cells, including those that have metastasised to sites distant from the original tumour. The rationale follows that of other GTAC approved protocols. After a short presentation by the proposers and discussion by Members, the Committee agreed to give this protocol approval subject to minor clarifications in the study protocol.

Item 8. Protocol Amendment: A multinational multi-centre randomised double-blind placebo controlled study to evaluate the efficacy and safety of Ad5FGF-4 patients with stable angina (GTAC 051).

Several text amendments had been submitted to GTAC. The Committee reached agreement that its previous decision to decline the request for an additional angiograph should be upheld. Members were asked to consider the remainder of the text amendments and to send their comments to the Secretariat in due course.

Item 9. Chairman's Actions.

There had been three Chairman's Actions since the last meeting. This was a straight-forward record and there was no comments.

Item 10. SAE Update.

Members had received the updated table on SAEs. No major issues were raised, however, a number of SAEs were flagged up as particularly noteworthy.

After discussion it was agreed that the Secretariat liaise with the MCA to further develop a co-ordinated approach to SAE reporting.

Item 11. Any Other Business.

British Society of Gene Therapy. Members were informed that there had been a preliminary meeting on Tuesday, 11 February at the MRC to discuss the possible formation of the BSGT. The BSGT are likely to hold an inaugural meeting in early 2004.

Members were informed of the annual European Society of Gene Therapy meeting in Edinburgh in November 2003. It was agreed that a special scientific session on retroviral gene therapy would be hosted by GTAC.

GTAC Secretariat
February 2003

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