Present: Professor Martin Gore (Chair), Professor Terry Hamblin, Mrs Fiona Sandford, Professor David Harrison, Mrs Debbie Beirne, Dr Adrian Lepper, Professor Nick Lemoine, Professor Andrew Baker, Professor Mary Collins, Bishop Dr Lee Rayfield, Dr Michael Waterhouse, Dr Richard Ashcroft, Dr Kathleen Bamford, Ms Claire Foster, Professor Hilary Calvert and Dr Stephen Minger (from item 5)
Secretariat: Dr Monika Preuss, Mr Daniel Gooch and Miss Joanna Edwards
Observers: Dr Sharon Longhurst (MHRA), David Brown (HSE) and Dr Michael Farrelly (from item 5)
Apologies: Dr Peter Harris and Mr Michael Harrison

Item 1: Welcome

The Chair welcomed the Committee to its 59th meeting and the first meeting under the chairmanship of Professor Martin Gore.

The Chair welcomed new members Ms Claire Foster, Dr Kathleen Bamford, Professor Hilary Calvert and Dr Stephen Minger and congratulated them on their recent appointment to the Committee.

Item 2: Minutes of the 58th meeting of GTAC

The minutes were agreed as an accurate and true record of the 58th meeting.

Item 3: Matters Arising

A number of letters had been sent out, and received, concerning correspondence arising from the last meeting. There were no substantial comments.

Item 4: Chairman's Actions

Fifteen letters were sent out under Chairman's Actions, none of which gave rise to any discussion.

Item 5: New Protocol GTAC 121:
An Open-Label Phase I Study of CGT-A310, A Tropism Mediated Oncolytic Adenovirus in Patients with Treatment-Refractory Metastatic Tumours

Professor Nick Lemoine declared an interest in this item and left the room.

This is a proposal designed for patients with a variety of refractory cancers including lung, breast, ovary, stomach, colon, pancreas and liver. The method makes use of an oncolytic adenovirus. It is hoped this will increase selectivity of the vector for cancer cells.

The Committee conditionally approved this trial.

Professor Lemoine returned to the meeting.

Item 6: New Protocol GTAC 122:
A Randomized Double Blind Dose-ranging Study to Assess the Safety, Tolerability and Immunogenicity of a Monovalent H5 DNA Influenza Vaccine Administered by Particle Mediated Epidermal Delivery (PMED) to Healthy Adults.

New Protocol GTAC 123:
A Prospective, Randomised, Double Blind, Placebo-Controlled Study to Assess the Efficacy of a Trivalent DNA Influenza Vaccine Administered by Particle Mediated Epidermal Delivery (PMED) Against a Controlled Influenza Virus Challenge.

Due to these two protocols being closely related they were discussed together.

The Committee conditionally approved both trials.

Item 7: SUSAR Update

GTAC reviewed the SUSARs received since the previous meeting none of which gave rise to any significant discussion.

NEXT MEETING - Wednesday, 13 September 2006, Skipton House

GTAC Secretariat

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