National Anti-vivisection Society

 

National Antivisection Society

Testing Breakthrough Can Save the Lives of Dogs and Primates in Laboratory Tests

Posted: 31 July 2008

Germany – A meeting held today in Bad Homburg, and attended by scientific and industry representatives from five EU countries, and representatives of the National Anti-Vivisection Society (NAVS), will report the findings of a Europe-wide trial into micro-dosing. They believe Europe should grasp the opportunity presented by micro-dosing to dramatically advance the replacement of animals in testing.

The European Union Microdose AMS Partnership Programme (EUMAPP), co-ordinated by Industry leader Xceleron and funded by the EU, is staging a workshop to reveal the findings from the two year sponsored study into the success of microdosing trials in human participants.

The NAVS, which has for several years being championing micro-dosing as a superior alternative to animal tests, believes that the technology could be used to rapidly replace toxicity and other tests currently undertaken on a second species – usually dogs or primates. This would be in line with the European Parliament Declaration adopted last year to set a timetable to replace experiments on primates throughout the EU.

On the Xceleron website spokesperson Dr Garner states:“Past studies suggest that in vivo animal models are not necessarily reliable predictors of drug absorption and elimination in humans and we have found human microdosing data to be more than 80% predictive. The benefits of microdosing in terms of cost savings, improved candidate selection, pipeline productivity, and risk mitigation are significant”

Microdosing involves giving ultra-low, safe, doses of new compounds to human volunteers and responses can then be analysed by Accelerator Mass Spectrometry (AMS). AMS is able to directly count individual atoms and is so sensitive it has the ability to detect a liquid compound even after one litre of it has been diluted in the world’s oceans. Many agree that the TGN1412 drug disaster would have been avoided by this approach – where human volunteers suffered terrible drug side effects that were not predicted in monkeys given doses 500 times stronger.

Adoption of micro-dosing as an animal test replacement would be a huge boost to the NAVS campaign to end primate tests in Europe and to secure improved rules for animal experiments in Europe.

NAVS Chief Executive, Jan Creamer, said:

“The European Commission is currently reviewing Directive 86/609/EEC on the use of animals in experiments, and is expected to make proposals for a revision this year. We have been very actively involved in this process, with the adoption of our Declaration to end primate tests with the signatures of 432 MEPS and numerous presentation to the Parliament and Commission. With cosmetics tests we showed that with the right commitment these tests could be replaced, the time is now right for a major shift in how regulatory testing is undertaken. The adoption of modern human based techniques will be good news for animals and good news for consumers.”

ENDS

NOTES TO EDITORS
Animal Experiments: Unreliable, unethical, unnecessary.
http://www.navs.org.uk

About Xceleron
Leveraging its proprietary methods and ultra-sensitive technology platform, Xceleron delivers the earliest possible, most relevant human insights to its clients enabling smarter and safer drug development decision-making in terms of productivity, pipeline value and profit. Xceleron maintains ongoing client engagements with 15 of the 20 largest pharmaceutical companies in the world and analyzed more than 200 molecules to date. For more information, log on to http://www.xceleron.com

About EUMAPP
EUMAPP is the European Union Microdose AMS Partnership Programme, coordinated by Xceleron Ltd., York UK, and funded by the European Commission. It comprises 10 organisations from 5 different countries (United Kingdom, Sweden, The Netherlands, France and Poland). The aim is to evaluate microdosing for drug development and to arrive at recommendations about how and when it could and should be used.

© National Anti-Vivisection Society