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| TGN1412 Clinical Trial Disaster Submission |
 A
3D model of the receptor protein (CD28) to which
TGN1412 binds on the surface of T-cells (immune cells). |
In March 2006, eight healthy male volunteers took part in a
Phase 1 trial of an anti-inflammatory monoclonal antibody, TGN1412, at a research unit in
Northwick Park Hospital, London. Six of the volunteers rapidly developed multiple
organ failure and although they are all now out of immediate danger the possibility of
long term disability can not be ruled out. |
| Preclinical tests in monkeys failed to predict such an
adverse reaction to the drug and an official investigation found no evidence that there
were any problems in the making, preparation or administration of the drug. An Expert Group was assembled to investigate the
scientific issues raised by this clinical trial, in terms of how it may affect future drug
trails of similar substances. FoA made a detailed submission to the Expert Group
highlighting our concerns about the over-reliance on pre-clinical information from animal
studies to assess the safety of new medicines and discussing how safer clinical trials
might be achieved without the need for more extensive animal based testing. The
submission was well received by the group which met in June and will be publishing an
interim report on the matter in due course. To view the submission click on the link
below.
 Click for the FoA TGN1412 Expert Group Submission.
The submission is also
included in a comment paper about TGN1412 in a recent issue of ATLA (Bhogal, N. and
Combes, R. [2006] An update on TGN1412. ATLA 34[3], 351-356).
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Replacing Animals in Septic Shock Research
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| Sepsis and multiple organ failure are common causes of
death in patients admitted to intensive care units. The incidence of sepsis
has been steadily increasing over the past 20 years. Animal models of sepsis have
the potential to result in substantial suffering and many have been shown to be poorly
representative of the human syndrome. However a number of non-animal methods show
promise in addressing this situation.
In 2004, FoA held an expert workshop
to discuss the methods that will replace animal experiments in septic shock research,
there strengths and weaknesses, and what might be useful ways to move forward.
Attending the workshop were sepsis researchers and clinicians from around the UK.
The consensus report of the workshop
has been published:
Langley, C. et al. (2005) Opportunities to replace
the use of animals in sepsis research. The report and recommendations of a Focus
on Alternatives workshop. ATLA 33(6): 641-648.
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| Adoption
of Animal Welfare Principles
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| The ways in which regulatory authorities can assist in
replacing animal procedures and in reducing the suffering caused to animals in safety
testing were highlighted in 1997, when a set of principles on animal welfare was drawn up
in collaboration with the Home Office. The principles are based on the replacement,
reduction and refinement of animal experiments (the Three Rs). In 2002 FoA published a paper aimed at
encouraging UK regulators to incorporate these animal welfare principles into their
guidelines. The paper reviews how well various authorities are implementing the
principles, and presents FoA's recommendations on where further effort is needed.
Reference: Jenkins,
E.S. & Langley, G. (2002) Adoption of animal welfare principles by UK
regulators. Toxicology 176: 245-251. (Presented on this site with the permission of the copyright
holder, Elsevier Press) |
| Accessing Information
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In 1998 FoA held a workshop: Accessing
Information on Reduction, Refinement and Replacement of Animal Experiments. The
recommendations of which were published in ATLA.
Reference:
Langley G. et al. (1999) Accessing information on the reduction,
refinement and replacement of animal experiments. Report and recommendations of a
Focus on Alternatives workshop. ATLA 27: 239-245.
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| EU Chemical Testing Programme
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FoA is extremely concerned
that the proposed EU chemical testing programme (REACH) will mean suffering and death for
large numbers of animals, because of this FoA has contributed to the debate on this policy
in the UK and Europe. |
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