Present: Professor Norman C Nevin (Chair), Ms Caroline Benjamin, Mr David Crosby, Professor Martin Gore, Professor Terry Hamblin, Professor David J Harrison, Mrs Ann Hunt, Professor Alex Markham, Professor James Neil, Revd Dr Lee Rayfield, Mrs Fiona Sandford, Dr Michael Waterhouse

Observers: Ms Liz Woodeson (DH), Dr Philip Harrison (MCA), Dr Mike Mackett (HSE), Mr Paul Heeney (HSE)

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

Item 1. Welcome and Apologies.

The Chairman welcomed Members to the 38th Meeting of GTAC. Apologies had been received from Professor Andrew Lever, who is on sabbatical in the USA, Mr Michael Harrison and Dr Lincoln Tsang (MCA). MCA were represented by Dr Philip Harrison. The Chair also welcomed Mr Paul Heeney from the HSE, who is a newly appointed Inspector.

Item 2. Minutes of (36^th and) 37^th meeting.

The MCA requested an amendment to the Minutes of the 36^th Meeting. The re-drafted 36^th Minutes been circulated to Members, along with minutes from the 37^th Meeting. Both sets of Minutes were accepted by members as a true record.

Item 3. Matters Arising:

The secretariat reported on a visit to a gene therapy research centre. This was mainly to provide input to standard operating procedures at the centre. After discussion, it was agreed to further liase with the Health and Safety Executive on the matter.

Item 4. Protocol:

A Phase I/II study to determine the optimum dose and dosing regimen then to assess the efficacy of a poly-epitope pharmaccine (therapeutic vaccine), involving pSG2.Mel3 and MVA.Mel3, in patients with Stage III or IV metastatic melanoma (OPO3/IVA/002)
University of Manchester.

The Chair informed members that this proposal is a follow-up to a previous study involving patients with malignant melanoma. Two vaccines were proposed, using DNA and a modified vaccinia virus, each containing melanoma epitope gene sequences. After a presentation by the proposers and discussion by Members, the study was granted conditional approval subject to a number of changes in the protocol and patient information.

Item 5. Protocol Amendment to GTAC044:

A Phase I/II study of the infusion of donor lymphocytes that have been engineered with the suicide gene HSV-tk after transplantation of allogenic T-depeleted stem cells from a related donor with partial compatibility in patients with haematological malignancies.
Hammersmith Hospital.

The Chair informed members of the background to this proposed amendment to the patient group in a protocol previously-approved by GTAC. Members considered and discussed this amendment and protocol in light of recent published work on retroviral marker transgenes. The amendment was granted approval.

Item 6. Protocol Amendment to GTAC047:

A Phase I randomised double-blind placebo controlled escalating dose, multi-centre study of Ad2/Hypoxia Inducible Factor (HIF)-1a/VP16 Gene Transfer administered by Intramyocardial injection during coronary artery bypass grafting (CABG) surgery in patients with incomplete revascularization,
University of Oxford.

This trial involves a parallel study being carried out in the United States and Europe, including the UK. The study sponsors sought to amend the dosing schedule of the study agent based on data from other gene therapy trials involving similar agents and based on data from the US arm of this study. After discussion, it was agreed to grant conditional approval to this amendment, subject to receipt of further satisfactory safety data from the US arm of the study.

Item 7. Chairman's Actions:

Approvals and amendments to pre-existing proposals which had taken place via Chairman's Actions between the 37^th and 38^th GTAC meetings were brought to the attention of members, who were ask if they had any comments.

Item 8. Any Other Business:

Members considered Serious Adverse Events (SAE) that had been reported to the secretariat since the last meeting. An SAE database was being prepared by the secretariat. The secretariat provided members with an update of the project, in conjunction with the Office of National Statistics, monitoring the long-term health of gene therapy patients. The secretariat informed members of the current status of discussions with COREC on governance arrangements for ethics committees. The committee was notified of a new malaria trial using DNA vaccination and asked for comment. No objections were raised.

GTAC Secretariat

August 2002

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