GTAC - Note of the 60th meeting
13 September 2006 |
Present: Professor Martin Gore (Chair), Professor Terry Hamblin,
Professor David Harrison (Chair for items 6 and 10), Mrs Debbie Beirne,
Dr Adrian Lepper, Professor Andrew Baker, Professor Mary Collins, Bishop
Dr Lee Rayfield (until item 7), Dr Kathleen Bamford, Ms Claire Foster,
Professor Hilary Calvert (from item 10), Dr Peter Harris (until item 9)
and Mr Michael Harrison (from item 5). Co-opted members (item 10): Professor
Barry Hancock and Professor Keith Wheatley
Secretariat: Dr Monika Preuss, Mr Daniel Gooch and Miss Joanna
Edwards
Observers: Dr Sharon Longhurst (MHRA), Dr Riaz Zurhie (MHRA) and
Dr David Brown (HSE)
Apologies: Dr Stephen Minger, Dr Richard Ashcroft, Dr Michael Waterhouse,
Professor Nick Lemoine and Mrs Fiona Sandford
Agenda items were taken at rearranged order throughout the day.
Item 1: Welcome
The Chair welcomed the Committee to its 60th meeting.
Item 2: Minutes of the 59th meeting of GTAC
The minutes were agreed as an accurate and true record of the 59th meeting
subject to the amendment of a typographical error.
Item 3: Matters Arising
A number of letters had been sent out, and received, concerning correspondence
arising from the last meeting.
Item 4: Chairman's Actions
Seven letters were sent out under Chairman's Actions since the last meeting,
none of which gave rise to discussion.
Item 8: Amendment GTAC 119
An Open-Label Dose Escalation Study of an Adeno-Associated Virus Vector
(AAv2/2-hRPE65p-hRPE65) for Gene Therapy of Severe Early Onset Retinal
Degeneration
The Secretariat had received an updated protocol and PIL for GTAC 119,
which was conditionally approved earlier in 2006. The conditions the Committee
had requested were included in the new protocol. Approval was also sought
for a substantial amendment to increase the maximum dose.
The Committee were content that all changes had been made to the PIL
and protocol and agreed to the substantial amendment.
Item13: Any other Business (part 1)
HSE Draft Guidance
The Secretariat had circulated by email draft guidance from the HSE about
the use of genetically modified organisms, including gene therapy vectors,
in the clinic. Dr Brown spoke briefly to this. Members were invited to
send written comments to the Secretariat, or directly to HSE, until the
end of September.
Amendment of GTAC 118 (TB vaccine in HIV patients)
The Secretariat received an application for approval of a substantial
amendment of GTAC 118. Approval for this amendment was granted.
Item 11: SUSAR Update
GTAC reviewed the SUSARs received since the previous meeting none of which
gave rise to any significant discussion.
Item 5: New Protocol GTAC 125
Restoring Dystrophin Expression in Duchenne Muscular Dystrophy: A Phase
I/II Clinical Trial using Antisense Oligonucleotides.
This protocol is a proof of principle study of a strategy to treat Duchenne
Muscular Dystrophy (DMD). The trial uses an antisense oligonucleotide,
which is designed to induce exon skipping as a therapeutic strategy. The
product is administered by intramuscular injection into a muscle on each
foot. One foot will receive the product. The objective of the trial is
to evaluate the safety and efficacy of a single intramuscular administration
of antisense oligonucleotide into nine patients with DMD.
The Committee conditionally approved this trial.
Item 6: New Protocol GTAC 126
A Phase II Study of the Efficacy, Safety and Immunogencity of OncoVEX
in Patients with Stage IIIc and Stage IV Malignant Melanoma.
As Professor Martin Gore was likely to be involved in the study at the
Marsden site, he decided to step down as Chair for this item (and left
the room). The Vice-Chair, Professor David Harrison chaired this session.
This was the fourth time the Committee had seen a trial protocol for
OncoVEX, this time as a potential treatment for Melanoma in patients with
Stage IIIc and Stage IV malignant Melanoma. OncoVEX is a Herpes Simplex
Virus based vector. The primary objective of this trial is to assess the
clinical efficacy of OncoVEX in terms of tumour response rates. Secondary
objectives are to assess the safety of OncoVEX in terms of adverse events,
biochemical and clinical efficacy.
The Committee conditionally approved this trial.
Professor Gore returned to the Committee.
Item13: Any other Business (part 2)
Response to the conditional approval letter of GTAC 115
A detailed response to GTAC's conditional approval letter of the Haemophilia
trial had been received asking the Committee for preliminary feedback
on the approach. Various points made on this item included the issues
of immunosuppression, bio-distribution, dosing, and vector integration.
The Patient Information Leaflet was also being re-reviewed.
The Secretariat agreed to feed back to the investigator the Committees
comments
Item 7: Review of the Genetics White Paper
A representative from the Department of Health joined the Committee for
a discussion on the Genetics White Paper of June 2003. The Department
of Health is currently reviewing the progress of the funding commitments
set out in the paper with regards gene therapy research and as such have
written to the Committee to seek its views on a number of issues as GTAC's
role as a Ministerial Government Body. All comments from the Committee
were fed back to the Department.
Item 12: Amendment 2 of the Flagging Project
The Secretariat had recently reviewed the flagging project and a number
of necessary amendments were made including changes to the PIL, GP letter
and questionnaire, also reflecting GTAC's recent advice that flagging
is only necessary for integrating vectors, AAV- and HSV- derived vectors.
The Secretariat will continue to look into the flagging project.
Item 9: New Protocol GTAC127
A Phase IIb Multicentric Controlled Study Evaluating the Therapeutic Vaccine
TG4010 (MVA-MUC1-IL2) as an adjunct to Standard Chemotherapy in Advanced
Non Small Cell Lung Cancer
This protocol is for Non-Small Cell Lung Adenocarcinoma. The study vector
is based on vaccinia virus and contains as the therapeutic gene load the
sequence for human mucine 1 (MUC-1), a tumour associated antigen, and
IL-2.
The Committee conditionally approved this trial.
Item 10: GTAC 124
An International, Randomized, Double-Blind, Placebo Controlled, Parallel
Group Study to Investigate Whether TroVax Added to First Line Standard
of Care Therapy Prolongs the Survival of Patients with Locally Advanced
or Metastatic Clear Cell Renal Adenocarcinoma.
The Committee were joined for the discussion of this protocol by Professor
Keith Wheatley and Professor Barry Hancock who joined as experts in statistics
and renal cancer medicine respectively. Professor Gore announced that
he had given informal and unpaid advice to the company which might be
perceived as a potential conflict of interest in this protocol. Therefore,
he left the room, as did Mrs Debbie Beirne and Dr Peter Harris. The Vice-Chair
Prof David Harrison chaired this session. Professor Collins declared that
she had been at the board to OBM but stepped down after her appointment
to GTAC, and that OBM supported work at UCL (but not in her laboratory).
This was not considered to constitute a conflict of interest.
GTAC 124 is a phase III survival study in patients with metastatic renal
cancer. TroVax, the product is well known to GTAC. In this trial, patients
are assigned to one of three groups depending on the local standard of
care (sub-cutaneous IL-2 treatment, IFN-a treatment, or in the USA Sunitinib
treatment). Once standard of care has been chosen, the participants will
be randomised to TroVax or placebo and will receive a single intramuscular
injection into the deltoid muscle on three occasions.
The Committee approved this trial.
Professor Gore returned to the Committee (but not Dr Harris and Mrs Beirne).
Item13: Any other Business (part 3)
Amendment of GTAC 83 (MetXia in pancreatic cancer)
An application for a small amendment to the GTAC 083 trial had been received.
The Committee approved the amendment.
NEXT MEETING: Wednesday, 13 December 2006, Wellington House
GTAC Secretariat
September 2006
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