Present:

Professor David Harrison (Chair), Ms Caroline Benjamin, Mrs Rosie Barnes, Mr David Crosby, Mr Michael Harrison, Ms Ann Hunt, Dr Andrew Lever, Professor Alex Markham, Professor James Neil, Dr Sohalia Rastan, Reverend Dr Lee Rayfield, Ms Irene Train.

Observers:

Dr Mike Mackett (Health & Safety Executive), Dr Brian Davis (Medicines Control Agency), Dr. Elaine Godfrey (MCA), Dr Lincoln Tsang (MCA).

Secretariat:

Dr Jayne Spink, Dr John Connolly, Mrs Margaret Straughan, Mrs Beryl Keeley

1. Welcome and Apologies.

Professor David Harrison acted as Chairman for this meeting, as Professor Norman Nevin was unable to attend. The Chairman welcomed Members to the 33^rd Meeting of GTAC. Apologies had been received from Professor Ian Hart. It was announced that Professor Anthony Pinching had resigned from the committee since the previous meeting.

2. Minutes of the 32nd Meeting.

The Chairman confirmed with the Members that a draft of the minutes was an accurate record of their previous meeting.

3. Proposal:

The Use of a cDNA Vaccine Encoding the Human MUC1 Gene in the Treatment of Patients with Advanced Breast Cancer - A Phase I/II Study.

The Chairman outlined the background of this proposal. The principle investigator had previously received approval by GTAC for a similar study. After discussion, the proposers made a presentation to the committee. The committee agreed to grant the project conditional approval, subject to minor amendments to the protocol, patient inclusion criteria and information leaflet.

4. Proposal:

A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of NVFGF1 in Patients with Severe Peripheral Artery Occlusive Disease.

The Chairman outlined the background of this proposal. After discussion of the members, the proposers made a presentation to the committee. The committee agreed to grant the project conditional approval, subject to some minor amendments to the protocol and patient inclusion criteria, information leaflet.

5. Proposal:

A Phase II, Multicentre, Double-Blind, Placebo-Controlled, Dose-Finding Study of ZYC101a in the Treatment of High-Grade Squamous Intra-Epithelial Lesions of the Uterine Cervix.

The Chairman introduced this proposal to members of the committee. The proposers made a presentation to the committee, which was followed by a period of questioning. After discussion, a committee decision on this proposal was deferred until more information was supplied by the proposers.

6 Proposal:

A Phase I, Multidose Study to Evaluate the Safety of Intramuscular Injections of HER-2 DNA AutoVac^TM (ME 103.1.1) in Patients with Metastatic Breast Cancer.

The Chairman introduced the proposal to the committee, after which, the proposers made a presentation. After extensive discussion, it was decided to defer a decision subject to the receipt of more information from the proposers.

7. Any Other Business.

Other committee business, including Serious Adverse Events from and amendments to a number of clinical trials, was outlined and discussed. The GTAC secretariat described the outcome of a meeting of theirs with the MCA. Two initiatives from external parties on gene therapy issues were discussed. The chairman informed members that there was progress in the appointment of new members to the committee. The chairman informed members that the next GTAC committee meeting was due to be held on 10 October.

The GTAC Secretariat

August 2001

Top

copyright: © | last updated 13 August 2002