Present: Professor Norman Nevin (Chair), Professor Terry Hamblin, Mrs Fiona Sandford, Professor David Harrison, Mrs Debbie Beirne, Professor Martin Gore, Dr Adrian Lepper, Professor Nick Lemoine, Professor Andrew Baker, Dr Mary Collins, Bishop Dr Lee Rayfield, Dr Peter Harris and Professor Andrew Lever, Professor Alex Markham, Mr Michael Harrison and Professor Angela Thomas (Co-opted)
Secretariat: Dr Monika Preuss, Mr Daniel Gooch and Miss Joanna Edwards
Observers: Dr Paul Logan (HSA) Dr Liz Pollitt (MHRA) and Dr Graciela Nowenstein Piery
Apologies: Dr Michael Waterhouse and Dr Richard Ashcroft

Item 1: Welcome

The Chair welcomed the Committee to its 58th meeting.

Item 2: Minutes of the 57th meeting of GTAC

The minutes were agreed as an accurate and true record of the 57th meeting.

Item 3: Matters Arising

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

Item 4: Chairman's Actions

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

Item 5: New Protocol GTAC 119:
An Open-Labelled Dose Escalation Study of Adeno-Associated Virus Vector for Gene Therapy of Severe Early Onset Retinal Degeneration

This is a proposal for a trial in individuals affected by severe early-onset retinal degeneration, an eye disease for which there is currently no treatment or cure. Individuals with this specific mutation find that central vision loss begins in the first decade of life and have little visual function left by the age of 50. The disease occurs due to mutations in the RPE65 gene. It is amongst the most common genetic eye disorders affecting both sexes.

Following some discussion, the Committee conditionally approved this trial.

Item 6: New protocol GTAC 120:
A Phase I Trial of AEG35156 Administered by 2 hour Intravenous Infusions into Patients with Advanced Cancers

This is a new phase I study with the antisense product AEG35156. The study proposes to administer AEG35156, a chemically synthesised antisense molecule to human XIAP mRNA. XIAP is commonly present at elevated concentrations in cancer cells. The approach is to reduce the amount of XIAP produced in cancerous tissues so that apoptosis of diseased cells can take place more readily.

After discussion the Committee conditionally approved this trial.

Item 9: New Protocol GTAC 117:
A Phase I/II feasibility trial to assess the safety, immunological activity and efficacy of TroVax plus Interferon-alpha (INF-a) in patients with advanced or metastatic renal cell cancer.

The vector is a highly attenuated Vaccinia Virus containing the human TAA 5T4 glycoprotein gene. 5T4 is found on the surface of many cancer cells and the strategy is to inform the immune system to the presence of the cancer cells so that the immune system of the patient can target and kill the cancer. This study is designed to look at TroVax plus Interferon-alpha (INF-a).

Following discussion, the Committee conditionally approved this trial.

Item 7: New protocol GTAC 116:
A Phase I/II Trial of T-cell Suicide Gene Therapy Following Allogeneic Haematopoietic Stem Cell Transplantation

GTAC 116 concerns an application for a new phase I/II trial of T-cell suicide gene therapy following allogenic haematopoietic stem cell transplantation. It uses a retrovirus carrying the genes for 2 proteins fused together, the TK (suicide) gene and the gene for human CD34.

After discussion the Committee conditionally this trial for patients who have undergone Haplo-Identical Transplantation.

Item 8: New Protocol GTAC 118:
A Phase I Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Healthy Volunteers who are Infected with HIV

This concerns a submission for approval of a new protocol of a Tuberculosis vaccine in healthy subjects who are infected with HIV. It involves a heterologous prime-boost (prime BCG) immunisation strategy using a MVA derived vector.

The Committee conditionally approved this trial.

Item 9: Presentation given by Oxford Biomedica

Representatives from OBM gave a brief presentation to the Committee on the company's oncology programme.

Item 10: SUSAR Update

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

Item 11: Any other Business

The Secretariat informed the Committee of the Northwick Park incident.

NEXT MEETING - Wednesday, 6 July 2006, Wellington House

GTAC Secretariat
June 2006

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