Present: Professor Norman Nevin (Chair), Mrs Debbie Beirne, Professor Martin Gore, Professor Terry Hamblin, Professor Jim Neil, Rev Dr Lee Rayfield, Dr Adrian Lepper, Dr Michael Waterhouse, Dr Richard Ashcroft, Professor Andrew Lever,
Dr Caroline Benjamin, Professor David Harrison, Mr Michael Harrison (morning only), Mrs Fiona Sandford (morning only), Professor Alex Markham (morning only), Professor Nick Lemoine (morning only), Dr Peter Harris (morning only).

Observers: Ms Liz Woodeson & Ms Elise Graves.

Secretariat: Dr Jayne Spink, Dr Monika Preuss, and Mr Daniel Gooch.

Item 1: Introduction

The Chair welcomed Ms Liz Woodeson, the new division head of the new Scientific Development and Bioethics Division of the Department of Health, within which the GTAC Secretariat works. The Chair also welcomed a PhD student from Nottingham University who is doing research into public perception of Government biotechnology policy, including gene therapy, who had asked to observe a GTAC meeting.

Item 2: Minutes of the 44th meeting of GTAC

The minutes were agreed, subject to a few minor amendments, as an accurate and true record of the meeting.

Item 3: Matters Arising

Correspondence. Five letters had been sent out concerning correspondence arising from the last meeting.

Update on White Paper commitments. The Secretariat gave an update on progress on the Government's White Paper's gene therapy commitments. A Commissioning Panel was set to meet in early February to make recommendations to DH Ministers on three commitments (single gene disorders, safety of gene therapy and cystic fibrosis research).

Update on the clinical trials regulations. The Committee discussed GTAC's position in the new framework of the clinical trials regulations. It was strongly felt that GTAC should be named in the Regulations.

Item 4: GTAC088: A Cancer Research UK Phase I trial in patients with advanced tumours

A background to antisense was given in the meeting papers. The therapeutic strategy to cancer employed in this study is to stimulate apoptosis of cancer cells. Apoptosis is synonymous with natural cell death and it is inhibited in many malignancies, allowing tumour cells to proliferate. The approach taken is to reduce the amount of a known inhibitor of apoptosis so that apoptosis of cancer cells can take place more readily. The proposers presented their study to the committee and responded to the reviewers' and GTAC's comments.

Following discussion, GTAC decided to approve the study subject to a few additional minor amendments in the patient information leaflet.

Two additional agenda Items

GTAC055 amendment - the prostate cancer trial. The proposers wished to recruit an additional cohort of patients to the study to enable further validation of the safety and potential for therapeutic benefit of the treatment. After discussion, the Committee decided to approve the amendment.

GTAC062 amendment. An HSV derived vector is used for the treatment of cancer. The applicants wished to amend slightly the dosing regimen in light of recent results. After discussion, the Committee agreed to approve the amendment subject to some minor conditions.

Item 5 - GTAC051: the angina trial

The Secretariat had been in correspondence with the sponsoring company, the consultant cardiologist, and a patient who wishes to be enrolled onto the trial. Members were supplied with the correspondence in the meeting papers for information. The issue was not yet closed and further correspondence will be supplied in the next meeting papers.

Item 6 - GTAC 045: Phase I clinical gene therapy protocol for X-SCID, Application to enrol a new patient

Great Ormond Street Hospital had sought GTAC's permission to enter a new patient into their gene therapy trial. Participating Members of the ESGT conference in Edinburgh attended a meeting on Sunday 16 November 2003 in Edinburgh organised solely to discuss this application and approved the treatment of the patient. Participating Members approved the minutes of the meeting.

Item 7 - Serious Adverse Event Update

Three new SAEs had been received since the last meeting. These SAEs gave rise to no concerns by the Committee.

Item 8 - Presentation by Andrew Paramore: "Market outlook for gene therapies"

Andrew Paramore, an analyst for Decision Resources International, gave a presentation on "Market Outlook for genetic therapies (in cancer)".

Item 9: Chairman's actions

Nine Chairman's actions has been taken since the last meeting. The committee was content with these actions.

Item 10: Any other Business

Register of Members' Interests. Members were invited to provide an update of their interests for publication in the 10th GTAC Annual Report. The Secretariat had started working on the draft report and aimed to have it ready for consideration at the February 2004 meeting.

The GTAC Public Day in Edinburgh. Also provided in the meeting papers was the Secretariat's analysis of the feedback forms of the GTAC Open day as well as a number of relevant press cuttings of news items which appeared in the Daily Telegraph the day after the meeting. The day was extremely well received and the Chair thanked participating Members.

The British Society for Gene Therapy. The inaugural meeting of BSGT was to take place in Oxford on 28-30 March 2004. Members were invited to attend.

Press cuttings

Press cuttings included articles on the world's first commercially available gene therapy agent which has been marketed in China, a number of articles on treating Parkinson's disease and blindness, and a number of recent news items on the X-SCID leukaemia cases. This had been triggered by an article in Science on the subject of retroviral gene transfer.

GTAC Secretariat
July 2004

Top

copyright: © | last updated 06 August 2004