GENE THERAPY ADVISORY COMMITTEE
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GENE THERAPY ADVISORY COMMITTEE |
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| Note of the twenty-second meeting of the Gene Therapy Advisory Committee (GTAC) held on 10 February 1999. Present Professor Norman C Nevin (Chair), Mrs Rosie Barnes, Professor Anthony Dayan, Canon Dr Keith Denison, Mrs Ann Hunt, Professor James Neil, Professor Michael Steel, Mrs Irene Train, Professor John Burn, Professor Anthony Pinching, Professor Patrick Johnston. Secretariat Dr Jayne Spink, Mrs Margaret Straughan, Mr Anthony Taylor Also Present Dr Elaine Gadd, Dr Jenny Sims (Medicines Control Agency) & Dr Lincoln Tsang (Medicines Control Agency). The meeting discussed the following issues: Flagging up of Gene Therapy Patients on NHS Register. A draft of the application form to use the Central Register to flag gene therapy patients was tabled for comments and suggestions. It was agreed that the Secretariat ask proposers to insert a paragraph in the Patient Information Sheet to draw the patients' attention to the fact that they will be flagged. Workshop "Hitting the Target with Gene Therapy" Report. The GTAC workshop was held on 19 November 1998 and was attended by 68 delegates. The proceedings document is nearing completion and will be placed on the web site. Proposal from St George's Hospital for a gene therapy trial of immunotherapy in malignant melanoma. The Committee agreed that it could not approve this application at this time. GTAC recognises the importance of research into new treatments for malignant melanoma and it was therefore agreed that the proposers be encouraged to submit a revised protocol taking into account the issues raised by members. Application to extend GTAC approval of a gene therapy study in patients with ovarian cancer to include a new site. St Luke's Hosptial, Guildford. The proposers sought to extend approval of an existing gene therapy study from the Hammersmith Hospital, Guy's & St Thomas's, Charing Cross and St Georges to include a new site (St Luke's Hospital, Guildford). Conditional approval by Chairman's action had been given while awaiting further information on site suitability. This information had been received and full approval subsequently granted. Protocol Amendment - gene therapy study in ovarian cancer, Hammersmith Hospital, London. The investigators sought to recruit an additional 2 groups of 3 patients with and without ascites bringing the total number of patients enrolled to 17. The approved protocol allows for up to 24 patients and Chairman's approval was given for this amendment on 27 November 1998. Protocol Amendment - gene therapy study in malignant melanoma, Glasgow Western Infirmary. The investigators sought to extend the maximum age of recruitment to allow for older but otherwise eligible patients to take part in the trial. Approval was granted by Chairman's Action on 4 January 1999. Directed Gene Repair. The Secretariat had received correspondence from Kings College Hospital regarding the future potential of targeted gene repair as a form of gene therapy. It was agreed to invite the investigator to the next meeting to talk to members about this new technique and to present a "pre-proposal" to outline its potential applications. Reports to the Committee. GTAC heard reports from its Chairman and Secretariat on the following matters; · Opening of a new GMP facility at Bristol. · Government review of biotechnology committees. · Meeting on DNA vaccines at the MCA (Chairman, Secretariat & the MCA). · Wellcome Trust Medicines in Society Programme. Dates of Next Meetings Wednesday, 12 May 1999. Wednesday, 14 July 1999. Wednesday, 13 October 1999. Wednesday, 15 December 1999. IMPORTANT NOTE. GTAC considers that gene therapy has not yet developed to the stage where it can be considered as treatment. All gene therapy is research and recruitment of patients into research trials takes place under strict rules set out by GTAC, under principles elaborated by professional bodies and only after review of clinical protocols by GTAC. |
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