GTAC - NOTE OF THE THIRTY- SECOND MEETING - 9 MAY 2001

Gene Therapy Advisory Committee Note of the Thirty-Second Meeting - 9 May 2001

GTAC Gene Therapy Advisory Committee Note of the 32nd Meeting Held on 9 May 2001 Present: Professor Norman C Nevin (Chair), Mrs Rosie Barnes, Mr David Crosby, Professor David Harrison, Mr Michael Harrison, Professor Ian Hart, Dr Andrew Lever, Professor Alex Markham, Professor James Neil, Reverend Dr Lee Rayfield. Observers: Dr Elaine Godfrey (Medicines Control Agency), Dr Lincoln Tsang (MCA). Secretariat: Dr Jayne Spink, Dr John Connolly, Mrs Margaret Straughan, Mrs Beryl Keeley   1. Welcome and Apologies. The Chairman welcomed Members to the 32nd Meeting of GTAC. Apologies had been received from Professor Anthony Pinching, Ms Caroline Benjamin, Mrs Ann Hunt, Mrs Irene Train and Dr Brian Davis (MCA).   2. Minutes of the 31st Meeting. The Chairman confirmed with the Members that a draft of the minutes was an accurate record of their previous meeting. One minor amendment was proposed.   3. Discussion on DNA vaccine trials. Members discussed with the Secretariat interactions with researchers interested in DNA vaccine trials. It was agreed that a sub-group of the committee and the Secretariat would meet with interested investigators. 4. A Phase I study to Evaluate the Safety, Tolerability and Immunogenicity of two administrations of either plasmid DNA (pSG2.HBs) versus placebo or modified vaccinia virus Ankara (MVA.HBs) versus placebo, followed by two boost administrations of MVA.HBs expressing Hepatitis B surface antigen in healthy male volunteers. Oxxon Therapeutics. The chairman introduced the background of this project to the members. After discussion, the proposers made a presentation to the committee. The committee agreed to grant the project conditional approval, subject to minor amendments to the subject inclusion criteria and information leaflet. 5. A pilot study of the safety and immunogenicity of a candidate HIV-1 Clade A DNA Vaccine, pTHr.HIVA, given by needle injection into the deltoid muscle in HIV-1 seropositive subjects receiving highly-active antiretroviral therapy. MRC Human Immunology Unit, John Radcliffe Hospital, Oxford. The chairman presented background information on this study to the members. The proposers joined the committee to give a short presentation of their work. After discussion, it was agreed to award conditional approval to the study, subject modifications to the protocol and minor changes to the patient information leaflet. 6. A multi-centre randomised double-blind placebo controlled dose-response study to evaluate the efficacy and safety of Ad5.1FGF-4 in patients with stable Angina. Schering Health Care and Berlex Laboratories. The chairman introduced background material to the members. He informed them that the Secretariat had met with the proposers to discuss issues raised at their 30th Meeting in relation to submission of a pre-proposal for this study. The proposers made a presentation to the committee. After lengthy discussion, it was agreed to grant conditional approval to the study, subject to extensive re-writing of the proposal and patient information leaflet. 7. ANY OTHER BUSINESS. Serious Adverse Event (SAE) reports were discussed by members of the SAE sub-group. A New GTAC Application Form had been drafted since the last meeting. The Proceedings and Abstracts form the GTAC workshop on March 2nd at Collindale were circulated. A proposal to organise a think-tank on current Adenoviral work was discussed. A copy of the Secretary's of State for Health speech on Genetics was circulated to the committee. The committee was informed that procedures to appoint new lay and specialist members to GTAC were at an advanced stage and it was hoped that new members could participate at the next GTAC meeting on 25 July, subject to the Ministerial appointments process. The GTAC Secretariat May 2001

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