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 Richard Ashcroft, Professor Andrew Lever, Professor Nick Lemoine, Dr Caroline Benjamin, Mr Michael Harrison, Mrs Fiona Sandford, Professor Alex Markham, and Dr Peter Harris.

Observer: Dr Mike Mackett (HSE), Dr Judith Seargent (DH) and Dr Philip Harrison (MHRA) (agenda items 4 to 7 inclusive only).

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

Item 1: Introduction

The Chair welcomed the Committee to its second meeting of 2004.

Item 2: Minutes of the 46th meeting of GTAC

The minutes were agreed as an accurate and true record of the meeting. An update was provided on a number of action points in the minutes.

Item 3: Matters Arising

Correspondence. Several letters had been sent out concerning correspondence arising from the last meeting. All ongoing issues from the last meeting were now resolved. An application from Great Ormond Street Hospital to enrol an new patient into the X-SCID study had been circulated to Members in early March. There was consensus that enrolment should be allowed and approval to enrol this patient was given.

Update on the White Paper commitments. John Reid announced the successful bidders for the single gene disorders and safety of gene therapy White Paper commitments on 29 March. Related press releases were included.

Oral update on the clinical trials regulations. The Government laid the Clinical Trials Regulations before both Houses of Parliament on 1 April 2004. These regulations will come into force on 1 May 2004. GTAC is named as the national research ethics committee for gene therapy and the appeals procedure discussed at the last meeting has also been successfully incorporated. The Chairman congratulated Dr Spink and Mr Harrison in particular for all their hard work on the regulations.

Item 4 - Presentation: A lentiviral vector for the treatment of Parkinson's disease

This agenda item concerned a presentation on a new product under development for Parkinson's disease. GTAC made a number of recommendations on the vector, the available preclinical data, and towards a possible future clinical protocol.

Item 5 - Chairman's Actions

Since the last meeting, eleven Chairman's Actions had been taken. There were no substantial comments.

Item 6 - SAE update

Three updates on SAEs previously reported to GTAC, and four new SAEs, had been received since the last meeting. There were no comments.

Flagging study returns to 2002 had been received which were presented to the Committee.

Additional agenda item: Treatment of Primary Glioma Patients with HSV1716

The Secretariat informed GTAC that it would shortly receive an application for a large efficacy study of HSV1716. The researchers asked GTAC for some ethical advice prior to submission. GTAC was also approached with a request for compassionate use of HSV1716 in a patient with recurrent glioma. The Committee agreed to this request and recommended that that a defined strategy should be in place to deal with any other new patients before the new proposed clinical trial starts recruiting.

Item 5 - GTAC 90: Study of HSV-Thymidine Kinase Gene Therapy for the Treatment of Patients with Operable High-Grade Glioma

This was the only new protocol to be discussed at the meeting. It is a phase III study in patients with operable primary or recurrent high grade glioma. The outlook for patients with this type of brain cancer is very bleak. Despite aggressive therapy, including surgery, the median survival for patients can be less than one year. The design of this study is based on the results from two previous clinical studies which resulted in an increase in the median survival for patients. The study product is an adenovirus derived vector which contains the gene for the enzyme thymidine kinase (TK). Dividing tumour cells producing TK are susceptible to killing by a drug called Ganciclovir. The treatment is designed to affect killing of diseased cells, not quiescent normal cells.

Representatives from the sponsoring company and the clinical investigator presented the proposal to the Committee and answered questions. After discussion, GTAC decided to approve the study subject to some minor amendments.

Item 8 - Standard operating procedures for GTAC

The Secretariat had prepared draft Standard Operating Procedures (SOPs) for GTAC. These are a requirement in the Clinical Trials Regulations. The Secretariat, was to finalise the document bearing in mind the comments made during the discussion.

Item 9 - Any other business

GTAC training elective: The Human Tissue Bill. A DH official gave a short, and well-received, presentation on the Human Tissue Bill.

Oral update on the antisense workshop. Members would soon receive the meeting papers for the antisense workshop on 12 May.

Oral update on the Public Meeting. The public meeting 2004 will take place in Cambridge on Tuesday 20 July, the day before the July GTAC meeting. Both meetings will take place in Cambridge.

Press cuttings

A number of press cuttings were also provided. Most of these cuttings cover the announcement of the White Paper funding for single gene disorders.

Next meeting: Wednesday, 9 June 2004.

GTAC Secretariat
July 2004

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