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Note of the 28th Meeting
of the Gene Therapy Advisory Committee (GTAC) held on 19th July 2000
Present:
Professor Norman C Nevin (Chairman),
Mrs Rosie Barnes,
Ms Caroline Benjamin,
Professor David Harrison,
Mr Michael Harrison,
Professor Patrick Johnston,
Dr Andrew Lever,
Professor Alex Markham,
Professor Anthony Pinching,
Reverend Lee Rayfield,
Mrs Irene Train.
Secretariat:
Dr Jayne Spink,
Dr Mark Bale,
Mrs Beryl Keeley,
Mrs Margaret Straughan.
Also Present:
Dr. Elaine Gadd (Depatment of Health),
Dr Brian Davis (Medicines Control Agency),
Dr. Elaine Godfrey (MCA).
1. Welcome and Apologies.
The Chairman welcomed four new members to the committee: Professor Alexander
Markham at the University of Leeds, Professor David Harrison at the University
of Edinburgh, Dr. Andrew Lever at the University of Cambridge and the
Reverend Dr. Lee Rayfield, a Church of England Vicar and member of the
Society of Ordained Scientists. Apologies had been received from Professors
James Neil and Ian Hart, Mr. David Crosby, Ms. Sohaila Rastan, Mrs. Marcia
Fry and Dr. Lincoln Tsang.
2. Minutes of 27th Meeting.
These had been circulated and with minor amendments, were accepted as
a true record.
3. Matters Arising.
Adenovirus Working Party.
Following a patient death in an adenoviral gene therapy trial in the USA,
a GTAC working party was convened to survey all adenoviral trials in the
UK. No evidence of any Severe Adverse Events (SAE's) in UK studies was
found. The Working Party gave specific recommendations for appropriate
patient monitoring in a minority of studies where the route of administration
was the same as that of the US trial. The Working Party report was sent
to all GTAC members and will included in GTAC's 6th annual report.
New Guidance.
The draft Guidance for gene therapy trials was given to members for comment.
Members were informed that GTAC had introduced a register to monitor all
patients from gene therapy trials, as will as any offspring from those
patients up to the age of 16 years.
4. Protocol: A phase I study
of Trovax in patients with metastatic colorectal cancer.
The Chairman summarised the background to members. The protocol received
favourable external review, though a number of issues concerning patient
participation and information leaflets were raised. Following extensive
discussion with the proposers, conditional approval was given subject
to a number of amendments to the original protocol.
5. Protocol: A phase I study
of DNA.Mel3 in patients with melanoma.
The members were given background information for this study. Following
favourable external review, conditional approval was given subject to
modifications to the patient information leaflets, patient inclusion criteria
and requirements for staff protection.
6. Protocol: A phase I/II
study of polyHER2 neu vaccine in the treatment of epithelial cancers.
The Chairman summarised this protocol. It was suggested that the study
should be limited to a more specific patient group and that the proposers
might take into account new pharmaceutical treatment, which could be available
for this condition. The proposal was rejected by the members. Members
agreed that; subject to additional pre-clinical data, more selective inclusion
criteria and amendments to the patient information leaflet; a resubmission
could be invited.
7. Protocol: Phase I study
of Onyx-015 in bladder cancer.
Background to this study was discussed by the GTAC. While the protocol
had received favourable external review, several issues were raised including
the need for approval from HSE and LREC. Conditional approval was given
subject to modification of patient information leaflets.
8. Any Other Business.
Approval by Chairman's Action.
A list of Chairman's actions since the last meeting was tabled for information,
including approval for an HIV study. It was agreed that correspondence
between the GTAC secretariat and the proposers would be distributed to
the members.
Change of Membership.
Letters of thanks had been sent to the exiting members. A letter of thanks
from Professor Anthony Dayan was read to members.
Date of Next Meeting.
It was agreed to hold the next meeting on Wednesday, 11 October. The Chairman
informed members that the Secretariat would arrange a further half-day
meeting to finalise New Guidance for clinical trials.
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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