Present: Professor Norman Nevin (Chair), Mrs Debbie Beirne, Professor Martin Gore, Professor Terry Hamblin, Dr Peter Harris, Professor David Harrison, Mr Michael Harrison, Professor Nick Lemoine, Professor Andrew Lever, and Professor Alex Markham (morning only).

Observers: Dr Philip Harrison (MHRA) and Dr Mike Mackett (HSE).

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

Item 1: Introduction

The Chair congratulated Professor Markham on his forthcoming post as the Chief Executive of Cancer Research UK. The Chair also announced that Lord Warner had replaced Lord Hunt as the Minister with responsibility for, amongst others, genetics and biotechnology.

Extra Agenda item: The White Paper Our Inheritance, Our Future - realising the potential of genetics in the NHS

The Secretariat detailed the sections of the Government's recently launched White Paper (WP) on genetics that made commitments for a substantial investment in gene therapy research. This money includes £3.0 million for gene therapy research into single gene disorders, £2.5 million for cystic fibrosis, additional funding for research into the long-term safety of insertional vectors, and up to £4 million to support academic access to gene therapy vector production facilities.

Calls for bids will go out at the end of August 2003 for the single gene disorders money, and policy options for the effective spend of the vector facility money will be considered.

Item 2: Minutes of the 42nd Meeting of GTAC

Following minor amendments, the minutes of the 42nd meeting were accepted as a true and accurate record.

Item 3: Matters Arising

Correspondence had been received from two previous GTAC applicants saying funding for their projects has collapsed and their clinical trials would now not go forward. The Chair expressed his hope that this was not an indication of a general trend. No comments were raised about the other seven items of correspondence.

Item 4: A phase I/II safety study of Met-Xia-OB83 in patients with pancreatic cancer, University of Liverpool

The vector for this study is a replication deficient retrovirus that contains the gene for cytochrome peroxidase P450. This protein converts a pro-drug (cyclophosphamide) into a toxic agent.

The proposers joined the Committee to present the proposal to GTAC. Following their presentation, GTAC discussed the proposal. The Secretariat was instructed to write to the applicants, stating that there was insufficient pre-clinical data to enable GTAC to make an informed decision on this protocol. However, the applicants should be invited expressly to resubmit the application once the preclinical data package is complete.

Item 5: A Phase I study to determine the safety of a single dose of gene modified dendritic cells for the treatment of malignant melanoma, University of Birmingham

Members were informed of the details of this clinical trial, which was a modified version of a previously approved trial.

This protocol is a DNA vaccine study for patients with malignant melanoma, which is a form of skin cancer. The approach used here is 'immunotherapy'. It is based on the idea that the immune system can be 'educated' to recognise tumour cells. The investigators wish to take dendritic cell precursors from the blood of patients. Following maturation, these cells will then be treated ex vivo with the study vector, and re-injected into the patients.

The investigator joined the Committee to present the proposal to Members. Following the presentation, GTAC discussed the proposal. The Committee decided to give approval, subject to some very minor amendments to the patient information leaflet.

Item 6: Phase I clinical gene therapy protocol for adenosine deaminase deficiency - Application to enrol a patient, Great Ormond Street Hospital

Members were advised that this agenda item arose from the decision of the GTAC/CSM working group to consider all applications for patient enrolment (on SCID trials) on a case by case basis.

The applicant gave a brief presentation on the clinical details of the patient, a young child for whom no matched donor was available. After considerable discussion, GTAC decided to give approval to treat the patient with gene therapy, so long as particular attention was paid to achieving fully informed consent of the parents. In reaching their decision, GTAC worked to the principled and recommendations of the GTAC/CSM working party on retroviral safety (GTAC/CSM working party, April 2003).

Item 7: Protocol Notification

One notification of a vaccination study in health volunteers had been received which was accepted by the Committee and recommended for review by the local REC.

Item 8: GTAC as the MREC for gene therapy

The issue of recognition of GTAC as the MREC for gene therapy was raised. Lord Hunt's letter confirming GTAC's status was now being circulated to all RECs.

Item 9: Chairman's Actions

There were no comments on the seven Chairman's actions taken since the last meeting.

Item 10: SAE Update

The Secretariat had supplied the latest version of the SAE database, together with a table analysing SAEs by vector and disease model.

Members were reassured by the exemplary investigations into an SAE discussed at the last meeting. Analysis ultimately showed the SAE not to have been caused by the study product. No other comments were made.

Item 11: Any other Business

Clinical Trials Regulations (update)

Mr Michael Harrison was thanked for his help in putting together GTAC's 9-point consultation response. This response pointed out concerns over the increased costs for academic independent research and sought clarification on three issues: the inspection of facilities; the status and Membership of ethics committees such as GTAC; and SAE reporting. The Secretariat will continue its work to resolve current issues.

New lay Members

The Chairman informed Members that the recruitment campaign for two new lay Members was going well - over 60 applications had been received, and 9 candidates had been interviewed. Hopefully new Members would be with GTAC for the next meeting. The Secretariat informed Members that it intends to organise a training day for new and existing Members and was open to ideas, and would also welcome volunteers to do the training.

Report from ASGT meeting

The Secretariat gave a brief report of the above conference. There had been numerous studies on the integration of viral vectors.

Open Meeting (update)

The open meeting will be held in parallel to the European Society of Gene Therapy annual conference in Edinburgh on Monday 17 November 2003. Suggested agenda items are:

• Ethics
  
• Public understanding of gene therapy
  
• Coverage of gene therapy in the media
  
• Patients (representatives)
  
• A round table discussion with GTAC Members answering questions from Members of the public.

EU Directive on Tissues and Cells

The Chair mentioned the new EU Directive on Tissues and Cells, which will also apply to some aspects of gene therapy. The details are still to be worked out with a view to implementation by April 2005. The scope of this Directive includes all human tissues used for therapeutic purposes including those used in clinical trials. Relevant examples for gene therapy are:

• All tissues including foetal tissues (e.g. neuronal cells and stem cells)
  
• haemopoietic progenitor cells (e.g. bone marrow, peripheral blood, cord and placental blood)
  
• donor leukocytes and granulocytes
  
• autologous cell systems.

The Directive is intended to provide a unified framework in order to ensure high standards of quality and safety across the EU and to facilitate the exchange of tissues. At present, the Department of Health voluntary Code of Practice for Tissue Banks applies. It applies to tissue banks supplying human tissues for therapeutic purposes. The Secretariat promised to circulate relevant papers to Members for comments.

Members photos

Members were asked to send the Secretariat electronic copies of their picture for use on the GTAC web-site.

Honours

The Secretariat congratulated Professor Nevin on his recently awarded OBE.

Next Meeting: Wednesday 15 October 2003 in Skipton House.

GTAC Secretariat
August 2003

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