Present: Professor Norman Nevin (Chair), Professor Terry Hamblin, Professor Jim Neil, Rev Dr Lee Rayfield, Dr Adrian Lepper, Professor David Harrison, Mrs Debbie Beirne, Professor Nick Lemoine, Professor Martin Gore, Dr Caroline Benjamin, Dr Peter Harris, Mrs Fiona Sandford.

Secretariat: Dr Monika Preuss, Dr Cathleen Schulte, Mr Daniel Gooch.

Observers: Dr Liz Pollitt (MHRA), Dr Paul Raptopoulos (MHRA), Dr Mark Bale (DH - items 1 to 10 only), Ms Shefally Yogendra (POST - item 5 only), Dr John Connolly (DH - items 1-3 only), Professor Stephen Minger (King's College London - items 1-3 only).

Item 1: Welcome

The Chair welcomed the Committee to its 52nd meeting, held at Hatton Gardens conference venue, London.

Item 2: Minutes of the 51st meeting of GTAC

The minutes were agreed as an accurate and true record of the 51st meeting.

Item 3: Stem cells and clinical research

Dr John Connolly, of the stem cells and cloning policy team at DH, had provided a briefing paper for GTAC to consider some issues surrounding the clinical applications of stem cell research. The paper explained, in outline, the scientific principles and regulatory background of stem cell research as well as questions that arise from the application of this technology to clinical research and treatment. Professor Stephen Minger, Centre of Age-Related Diseases, King's College London, gave a presentation on the scientific aspects and therapeutic applications of stem cell research. GTAC briefly discussed the issues.

Item 4: Matters Arising

A number of letters had been sent out (and received) concerning correspondence arising from the last meeting which did not give rise to major discussions.

Item 5: GTAC 100: A phase II study of NY-ESO-1 ISCOMATRIX vaccine and NY-ESO-1 ISCOMATRIX vaccine followed by recombinant fowlpox NY-ESO-1 (rF-NY-ESO-1) in patients with high-risk, resected NY-ESO-1 positive melanoma and prostate carcinoma

Professor Gore declared an interest in this trial, as he would be PI on a similar trial, and would have peripheral involvement. NY-ESO-1 is a highly immunogenic, tumour specific antigen that is expressed in a variety of cancers including prostate and melanoma. This is a two arm study in which patients will either receive six doses of the NY-ESO-1 protein mixed with the adjuvant or they will receive three doses of this followed by three doses of recombinant fowlpox virus encoding the NY-ESO-1 protein. A common problem encountered with viral tumour vaccines is that once patients have been immunised with the recombinant virus the immune system might subsequently elicit a greater immune response against the virus than the antigen itself. By injecting with protein first it is hoped that the immune response will be directed mainly towards the antigen, and thus the cancer. The trial will enrol high-risk melanoma and prostate carcinoma patients. After a presentation and question and answer session with the proposers, GTAC decided to give conditional GTAC approval. The two main conditions were to amend the randomisation of the trial to improve statistical validity and to amend the PIL.

Item 6: Chairman's Actions

Since the last GTAC meeting, thirteen Chairman's Actions had been taken, none of which gave rise to any discussion.

Item 7: HSE Consultation

The HSE has sent GTAC a copy of its consultation document on proposed amendments to the Contained Use Regulations. These Regulations are one of the key pieces of legislation relevant to gene therapy in the laboratory. The Committee had no particular comments in relation to clinical gene therapy.

Item 8: Draft Annual Report

Members had been provided with a draft copy of GTAC's 11th annual report and were asked for their opinions on various parts of the report. GTAC discussed and provided a number of suggestions.

Item 9: Lentiviral update

A brief update was provided regarding progress on the issue of lentiviral safety. The Secretariat had included copies of statements made by the HSE body SACGM, ESGT, the Paul Ehrlich Institute, and MHRA's CPMP, but there was no new information.

Item 10: GTAC045: Phase I clinical gene therapy protocol for X-SCID - New SAE in French X-SCID study

This concerned the third reported case of an adverse event in the French X-SCID trial. Three patients have now been diagnosed with T-cell proliferation. The Secretariat had been corresponding with Professor Alain Fischer to ask for more details regarding this new case. A tabled paper was provided giving the latest information as of 9 February 2005. It also gave a complete list of patients treated and the time passed since the treatment was administered. The ESGT had issued a statement on this SAE, a copy of which was also provided. The Committee for Safety of Medicines (CSM) had suggested a joint meeting with GTAC on 7 March 2005 to be updated on information relating to all aspects of the French trial, as a follow-up to the April 2003 GTAC/CSM joint meeting. The Secretariat and a number of GTAC members would attend the working group meeting.

There was considerable discussion about this item, particularly on whether any differences between the UK and French studies could explain the situation. GTAC agreed that Great Ormond Street Hospital should be advised not to discuss the option of gene therapy with patients/parents until further notice.

Item 11: White paper vector £4 million

There was an update regarding the spending of the vector money.

Item 12: Future monitoring of SAEs and SUSARs by GTAC

This concerned the future handling of SAEs and SUSARs in the light of the requirements of the Clinical Trial Regulations. The Secretariat provided a paper outlining the definition for SAEs and SUSARs and the current reporting requirements for both under the Regulations. There was some discussion about how best to address this issue, taking into account the requirements of the CTR, and also the appropriate process for dealing with annual safety reports from trials. GTAC was content to receive in future SUSARs as outlined in the CTRs.

Item 13: SAE Update

The Secretariat had received a number of new SAEs since the last GTAC meeting. None of the SAEs raised any substantial comments.

Item 13: Any other business

The Secretariat gave a brief report on progress with the plans for the GTAC public meeting on Sunday 3rd April 2005, and Members provided a few suggestions for parts of the programme.

Finally, Rev Dr Lee Rayfield was congratulated on the news that he was shortly to become the Bishop of Swindon.

Item 14: Press cuttings

The Secretariat had prepared a number of press cuttings, and scientific papers, for information. None of these items caused any discussion.

Next meeting: Wednesday and Thursday, 13 and 14 April 2005.

GTAC Secretariat
21 March 2005

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