New data strengthens case to replace animals in lab tests with microdosing

24 June 2008

The European Union Microdose AMS Partnership Programme (EUMAPP) consortium has announced the preliminary results of a 30-month, €2m project studying the use of microdosing in drug development. The findings were presented at the European Federation for Pharmaceutical Sciences (EUFEPS) Conference in Bad Homburg, Germany on 16 June.

The compounds selected for EUMAPP were chosen to rigorously test the predictability of human microdosing by studying drugs that exhibited properties in humans that are difficult to predict in animal or in vitro models and drugs with properties that, it was suspected, might be difficult to predict at a therapeutic dose from microdose data.

On reviewing the preliminary EUMAPP data Dr Colin Garner, President and CEO of Xceleron and Chair of the EUMAPP steering committee commented: “The outputs of the programme need to undergo rigorous scrutiny and detailed interpretation, but the early indications are that results strongly endorse the ability of microdosing to provide valuable human data at the earliest stages of exploratory clinical development.”

Dr Roeline Jochemsen, Director of Clinical Pharmacokinetics & Pharmacometrics at Institut de Recherches Internationales Servier observed that “The EUMAPP study provides increased confidence in the predictivity of Microdosing”.

Professor Malcolm Rowland, Scientific Advisor to the EUMAPP consortium said: “Generally the EUMAPP results are sufficiently encouraging to continue to support the view that, applied intelligently, microdosing coupled with AMS, offers an additional tool to facilitate earlier than otherwise possible decisions in candidate selection”.

Recently Xceleron announced that it has developed a database of 25 compounds with data on both microdose and pharmacological dose that show 80% predictability of pharmacokinetic parameters over dose ranges of a hundred-fold and more (in some cases many thousand-fold) for a diverse range of compounds.

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 that it has the ability to detect a compound even after one litre of it has been diluted in a volume of liquid equivalent to the world’s oceans. Many agree that the TGN1412 drug disaster could have been avoided by this approach — in this drug trial human volunteers suffered terrible side effects that were not predicted in monkeys given doses 500 times stronger.

The use of micro-dosing as an animal test replacement would be a huge boost to the National Anti Vivisection Society (NAVS) campaign to end primate tests 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.”

Your browser does not support inline frames or is currently configured not to display inline frames.	Your browser does not support inline frames or is currently configured not to display inline frames. New data strengthens case to replace animals in lab tests with microdosing 24 June 2008 The European Union Microdose AMS Partnership Programme (EUMAPP) consortium has announced the preliminary results of a 30-month, €2m project studying the use of microdosing in drug development. The findings were presented at the European Federation for Pharmaceutical Sciences (EUFEPS) Conference in Bad Homburg, Germany on 16 June. The compounds selected for EUMAPP were chosen to rigorously test the predictability of human microdosing by studying drugs that exhibited properties in humans that are difficult to predict in animal or in vitro models and drugs with properties that, it was suspected, might be difficult to predict at a therapeutic dose from microdose data. On reviewing the preliminary EUMAPP data Dr Colin Garner, President and CEO of Xceleron and Chair of the EUMAPP steering committee commented: “The outputs of the programme need to undergo rigorous scrutiny and detailed interpretation, but the early indications are that results strongly endorse the ability of microdosing to provide valuable human data at the earliest stages of exploratory clinical development.” Dr Roeline Jochemsen, Director of Clinical Pharmacokinetics & Pharmacometrics at Institut de Recherches Internationales Servier observed that “The EUMAPP study provides increased confidence in the predictivity of Microdosing”. Professor Malcolm Rowland, Scientific Advisor to the EUMAPP consortium said: “Generally the EUMAPP results are sufficiently encouraging to continue to support the view that, applied intelligently, microdosing coupled with AMS, offers an additional tool to facilitate earlier than otherwise possible decisions in candidate selection”. Recently Xceleron announced that it has developed a database of 25 compounds with data on both microdose and pharmacological dose that show 80% predictability of pharmacokinetic parameters over dose ranges of a hundred-fold and more (in some cases many thousand-fold) for a diverse range of compounds. 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 that it has the ability to detect a compound even after one litre of it has been diluted in a volume of liquid equivalent to the world’s oceans. Many agree that the TGN1412 drug disaster could have been avoided by this approach — in this drug trial human volunteers suffered terrible side effects that were not predicted in monkeys given doses 500 times stronger. The use of micro-dosing as an animal test replacement would be a huge boost to the National Anti Vivisection Society (NAVS) campaign to end primate tests 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.” Your browser does not support inline frames or is currently configured not to display inline frames. To top	Your browser does not support inline frames or is currently configured not to display inline frames.