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Note of the 30th Meeting
of the Gene Therapy Advisory Committee (GTAC) held on 11 & 12 December
2000.
DAY ONE: 11 December.
Present:
Professor Norman C Nevin (Chair),
Ms Caroline Benjamin,
Mr David Crosby,
Professor David Harrison,
Mr Michael Harrison,
Mrs Ann Hunt,
Professor Andrew Lever,
Professor Alex Markham,
Professor James Neil,
Professor Anthony Pinching,
Reverend Dr Lee Rayfield,
Mrs Irene Train
Secretariat:
Dr Jayne Spink,
Mrs Beryl Keeley,
Mrs Margaret Straughan
Observers:
Dr Elaine Godfrey (MCA)
1. Welcome and Apologies.
The Chairman welcomed the members to GTAC's 30th Meeting. Apologies had
been received from Professors Ian Hart (for 11th December), Patrick Johnston,
Mrs Rosie Barnes and Dr Sohaila Rastan.
2. Minutes of last meeting.
Subject to minor typographical alterations, these minutes were accepted
as a true record of the previous GTAC meeting.
3. Pre-Proposal: Randomised
double-blind placebo study Ad5.1FGF-4 in patients with stable angina.
The chairman outlined the background of this pre-proposal and members
discussed a number of issues including the inclusion criteria of patients
and investigational procedures. It was agreed to write to the proposers
to highlight thses issues.
4. Protocol: A phase I randomised,
double-blind placebo controlled study of Ad2.HIF1a/VP16 administered by
intra myocardial injection during CABG. Oxford Heart Centre, John Radcliffe
Hospital.
The chairman provided the background information of this study to the
committee. Several issues were discussed, including the suitability of
the proposed trial centre. The proposers made a presentation to the committee,
after which conditional approval was given subject to modifications to
the protocol and patient information leaflet.
5. Handling of Severe Adverse
Events and Long-term Monitoring.
Members received details of SAEs from a number of trials. There was increased
willingness to report SAEs to GTAC and the committee agreed to establish
a sub-group to analyse SAEs and monitor trials long term. The sub-group
was to consist of the Chairman, the Secretariat, Profs. Anthony Pinching,
David Harrison and James Neil.
DAY TWO: 12 December.
Present:
Professor Norman C Nevin (Chair),
Ms Caroline Benjamin,
Mr David Crosby,
Professor David Harrison,
Mr Michael Harrison,
Professor Ian Hart,
Mrs Ann Hunt,
Professor Andrew Lever,
Professor Alex Markham,
Professor James Neil.
Professor Anthony Pinching,
Reverend Dr Lee Rayfield,
Mrs Irene Train
Secretariat:
Dr Jayne Spink,
Mrs Beryl Keeley,
Mrs Margaret Straughan,
Dr John Connolly
Observers:
Dr Elaine Gadd (DH),
Dr Elaine Godfrey (MCA)
1. Welcome and apologies.
The Chairman welcomed members to the second day of the meeting. Apologies
had been received from Professor Patrick Johnston, MrsRosie Barnes and
Dr Sohaila Rastan. The Chairman also welcomed Dr John Connolly as a new
member of the Secretariat.
2. Protocol: Phase I clinical
gene therapy trial for X-SCID. Great Ormond Street Hospital. The chairman
introduced the background material for this study to the members. Children
suffering from this disease are often referred to as "bubble babies."
The proposers presented their protocol to the committee. The committee
deferred approval subject to modification of both the protocol and patient
information leaflet.
3. Protocol: Phase I clinical
gene therapy trial for X-CGD. Great Ormond Street Hospital . The chairman
provided members with an introduction to the disease and the porposed
trial. The proposers made a presentation to the committee members. Following
discussion, conditional approval was granted subject to modifcations in
the study protocol and patient information leaflet.
4. Protocol: A randomised
phase I trial of intravenous CI-1042 with or without entanercept in patients
with metastatic carcinoma. Hammersmith Hospital.
Members were briefed on the background to the proposed study, which
would involve the use of a modified adenovirus in patients with certain
cancers. The proposers made a presentation to the committee. After discusssion,
the committee clarified certain conditions, which would be required for
the proposed trial to proceed.
5. Any Other Business.
Members were informed of details of the GTAC workshop for 2 March 2001,
of the background to an erroneous media story on gene therapy and the
progress of the European Clinical Trials Directive.
IMPORTANT NOTE.
All gene therapy is research and recruitment of patients into research
trials takes place under strict rules set out by GTAC, under principles
elaborated by professional bodies and only after review of clinical protocols
by GTAC.
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