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GTAC - Note of the 34th meeting
10 October 2001

Present: Professor Norman C Nevin (Chairman), Mrs Rosie Barnes, Ms Caroline Benjamin, Mr David Crosby, Dr Martin Gore, Professor David Harrison, Mr Michael Harrison, Professor Ian Hart, Mrs Anne Hunt, Professor Alex Markham, Reverend Dr Lee Rayfield.

Observers: Dr Gerald Haase (MCA), Dr Mike Mackett (HSE), Dr Ragini Shivji (MCA), Ms Marianne Travers (DH), Ms Liz Woodeson (DH).

Secretariat: Dr John Connolly, Dr Jayne Spink, Mrs Margaret Straughan

1. Welcome and Apologies.

The Chairman welcomed Members and Observers to the 34^th Meeting of GTAC and thanked Members and Secretariat for well wishes he had received during his illness. The Chairman was delighted that four new Members had been appointed to GTAC: Dr Martin Gore from The Royal Marsden who would provide expertise in oncology; Professor Terence Hamlin has expertise in haematology, Dr Michael Waterhouse whose background is in the media and Mrs Fiona Sandford who is involved in primary immuno deficient group of patients. Chairman also informed Members that Mr Michael Harrison and Ms Caroline Benjamin had accepted a second term of office.

Apologies had been received from Dr Brian Davis, Professors Andrew Lever, James Neil, Drs Sohaila Rastan, Lincoln Tsang and Mrs Irene Train.

2. Minutes of 33^rd Meeting.

Minutes of the 33^rd GTAC meeting had been previously circulated to Members and, with the exception of a few typographical errors, these were accepted as a true record.

3. Protocol: First Administration to Man of an Oncolytic Herpes Virus Vector Containing a Transgene for Granulocyte Macrophage Colony Stimulating Factor (Oncovex^GM-CSF) - A Study of its Safety, Biodistribution and Biological Activity.

The Chairman outlined the background of this proposal. The study involved the delivery of a novel Herpes-based viral vector into tumour tissue from cancer patients. After discussion amongst members, the proposers made a presentation to the committee. The committee agreed to grant the project conditional approval, subject to the provision of additional pre-clinical work, amendments to the patient population and patient information leaflet.

4. Pre-proposal: Pre-proposal of a recombinant Modified Vaccinia Ankara (MVA) based vaccine encoding Epstein-Barr virus target antigens: a trial in healthy volunteers.

The Chairman outlined the background to this pre-proposal. The investigators wish to conduct a vaccine trial in healthy volunteers using antigens from Epstein Barr Virus (EBV). EBV is linked to a variety of illnesses such as Hodgkin's disease and nasopharyngeal carcinoma. After discussion, members agreed that this proposal should be reviewed in full by the committee at a future meeting.

5. Any Other Business.

Members were informed of the details of any Chairman's actions that had taken place since the last committee meeting. A meeting of ACRE on "deliberate" versus "contained release" issues in gene therapy clinical trials was discussed. The secretariat described progress towards a new procedure for the reporting and monitoring of Serious Adverse Events in gene therapy trials. Members were informed of progress towards both US and UK standards for Adenoviral Reference Working materials. It was agreed to examine the possibility of producing guidance for proposers wishing to conduct clinical trials using lentiviruses. New COREC guidelines for the running of ethics committees in the UK were considered by members. Comments from members on a draft of the GTAC seventh annual report were received. It was announced that the next GTAC meeting would take place on 12 December 2001.

The GTAC Secretariat
October 2001

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