AstraZeneca to help Biovator replace in vivo allergy testing
in vitro test for identifying potential allergens that
could replace many experiments on animals.
The deal to develop the test comes as an increasing number of people are trying to replace animal testing procedures with in vitro options that have the potential to be faster and more accurate than the traditional animal experiments.
The companies are aiming to have the test on the market by 2009, when the European Union will ban the use of animal experiments to determine the risk of allergic reactions to drugs, cosmetics and foods.
"There is a significant need for this kind of test - in the pharmaceutical sector as well as other industries that are introducing new substances and compounds into the marketplace," says Dr Karin Cederbrant, head of AZ's department of Immunotoxicology.
"Taking part in the creation of dependable ways to eliminate the need for using live animals is totally in-line with our policy."
Testing for allergic reactions in animal models is expensive and because the tests are not species specific do not always accurately predict adverse human immune reactions.
The issue of 'species specificity' was highlighted by the TeGenero Northwick trial tragedy where the severe adverse effects observed in the six human volunteers were not seen in preclinical studies on monkeys.
There are five different classes of allergy, ranging from immediate (Type 1), antibody dependant (Type 2), immune complex (Type 3), cell mediated (Type 4) and stimulatory (Type 5).
The current development phase is focussing on developing a kit which can identify Type 1 and Type 4 allergens - the most common allergy classes.
According to Karin Mattson, project coordinator at Biovator, AZ will be helping with the validation of the kits, testing the results gained with the prototype kits for investigational new drugs against those gained from traditional animal models.
"We're definitely seeing a ground swell of enthusiasm and interest in our method as a substitute for conventional testing on animals," said Stan Mikulowski, Biovator's CEO.
"Working together with AZ helps us exchange valuable skills and experience, and we see this as a crucial step in the creation of new products to meet the coming EU directives."
