Present: Professor Norman C Nevin (Chairman), Dr Sohaila Rastan, Dr Andrew Lever, Professor David Harrison, Mr Michael Harrison, Dr Michael Waterhouse, Mrs Ann Hunt, Mrs Fiona Sandford, Professor Ian Hart, Mr David Crosby, Professor Terry Hamblin, Ms Caroline Benjamin, Dr Martin Gore, Professor James Neil, Professor Alex Markham, Mrs Rosie Barnes

Observers: Dr Mike Mackett (HSE), Dr Gerald Gaase (MCA), Dr Lincoln Tsang (MCA)

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

Welcome and Apologies:

The Chair welcomed Members to the 35^th Meeting of GTAC. He also welcomed four new Members: Professor Terry Hamblin, specialist in haematology and oncology at the Royal Bournemouth and Christchurch Hospital; Dr Michael Waterhouse, Media producer and author from Southborough, Kent; Mrs Fiona Sandford, who was welcomed at the last meeting and Dr Martin Gore. The Committee said farewell to Rosie Barnes and thanked her for her commitment and valuable contributions and also Dr Sohaila Rastan, also attending her last meeting and thanked her for her support. Apologies had been received from Mrs Irene Train, Reverend Dr Lee Rayfield and Dr Brian Davis. Professor Neil also apologised as he had to leave at lunch time. The 7^th Annual Report had been tabled which had been published that day. The Report covers the period 1999-2000 and covers all projects approved by the Committee since 1993.

Minutes of last meeting:

Draft Minutes of the 34^th GTAC meeting had been circulated to Members. Members asked for minor amendments to be made, after which the minutes were accepted as a true record.

Chairman's Actions:

Approvals and amendments to pre-existing proposals which had taken place via Chairman's Actions between the 34^th and 35^th GTAC meetings were brought to the attention of members, who were ask if they had any comments. No major issues or concerns were raised.

Protocol: A Phase I trial of polyHER2neu - a polyepitope DNA vaccince encoding HER-2 epitopes in the treatment of breast cancer. St James Hospital, Leeds.

The Chairman presented background information on this proposal. The proposal in its original format was rejected in 2000, but invited by the committee for re-consideration at a later time-point. Before the proposers joined the meeting Professors Ian Hart and Alex Markham declared a potential conflict of interest. Professor Markham left the room. The proposers joined the committee to present the proposal to the members. After considerable discussion, it was agreed to give conditional approval , subject to further pre-clinical work and several amendments to the protocol and patient information leaflet.

Protocol: A Phase I trial of PolyMEL, a polyepitpe DBNA vaccine in the treatment of metastatic melanoma patients. St James Hospital, Leeds.

The Chairman outlined the background of the proposal to the committee. The proposal had been submitted to three external assessors and no major issues were raised. The Proposers joined the committee to present their protocol. After some discussion it was agreed to grant condition approval subject minor alteration to the patient inclusion criteria and Patient Information Leaflet.

Protocol: VTP-1/01: A phase I/II trial of intravenous vs hepatic arterial infusion of an E1A-CR2 deleted adenovirus (VTP-1) in patients with inoperable metastatic colorectal carcinoma. Hammersmith Hospital, London.

The Chairman outlined the purpose and scope of this proposal to members. He pointed out the, although the submission had been withdrawn for official assessment at this meeting, it was to be resubmitted at a later date in 2002. It was felt that it would be useful to supply the proposers with germane comments form the committee members on this study.

Protocol: A Phase I trial of replication-competent herpes simplex virus (ICP 34.5 null mutant 1716) in patients with inoperable malignant pleural mesothelioma. University of Glasgow.

The Chairman outlined the background of this proposal. Several points had been raised by external reviewers. After lengthy discussion, it was agreed to defer a decision pending clarification of a number of issues. A meeting would be arranged between the proposers and the secretariat.

Any Other Business:

Serious Adverse Events on gene therapy trials were brought to the attention of the committee. The secretariat informed members of the GTAC open day and policy forum, both to be held in March 2002. Members were reminded of a meeting to be held on DNA vaccines in January 2002. The Chairman informed members of the outcomes of his meetings with the Ethics Committee central office and the chairman of the Advisory Committee on Releases to the Environment. Members were asked for input into the Government Green Paper on provision of future genetic healthcare in the NHS. Members were asked to comment on a new Code of Practice for GTAC members, which had been drafted by the Secretariat. The dates of 2002 GTAC meetings were announced by the Chairman.

GTAC Secretariat
January 2002

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