Notice to shareholders

25 February 2008 – We have recently been in direct contact with University Departments in the United States and the Australasia region. The reason for these meetings was to further discuss and prioritise a number of clinical trials and studies being conducted and/or proposed by various institutions. All concern AIMSPRO and Daval's veterinary product, Ceremben.

In the US, Regulatory Consultants are supervising the first of two IND applications which will include studies of two demyelinative indications. In Australia, three trials, concerning an aspect of wound healing, a neuronopathy and a further demyelinative indication, are about to enter the CTX process. A second MHRA CTA application has been lodged for an anti-inflammatory indication in the UK, decision pending, with possibly a third to follow.

While two of the prospective clinical trials relate to common human medical conditions, the remainder are Orphan indications. It will be recalled that AIMSPRO has already been awarded an Orphan Drug designation by the TGA in Australia (Krabbe's disease).

Following evidence from veterinary specialists, that treated companion animals are responding well to Ceremben, Daval has decided to focus on animal needs and welfare in addition to addressing human disease. One study should be complete by mid-year, a second, which will address unresolved questions regarding treatment pathways, has recently commenced and a third has achieved ethics committee approval. This latter, double blind, placebo controlled, study is a treatment trial of a disease prevalent in horses.


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