ART621 - PHASE II TRIALS UNDERWAY

ART621 is based on a new type of therapeutic protein called a domain antibody.

A number of anti-TNF products (Humira^®, Remicade^® and Enbrel^®) are currently on the market for the treatment of rheumatoid arthritis. Unlike previous treatments, such as aspirin, that deal only with the signs and symptoms, the anti-TNF products may prevent and / or reduce further progression of the disease.

Global sales for these products totalled over US$13 billion in 2007 and are projected to rise to about $20 billion by 2012.

However, new antibody-based treatments are still needed because some patients have developed resistance and many stop responding to a particular anti-TNF antibody after pro-longed use, but still respond when switched to a different one.

ART621 is the first product incorporating human framework domain antibodies (dAb) to be used in human trials. Domain antibodies exhibit the binding properties to a target characteristic of a full-sized antibody, but are considerably smaller. This smaller size has several possible advantages including improved manufacturing yield, lower immunogenicity and improved tissue penetration.

In animal models of rheumatoid arthritis, ART621 matched the performance of one leading anti-TNF antibody product currently on the market and displayed favourable properties in terms of stability, duration of action and tissue localisation within the body.

ART621 is now in Phase II trials with an open IND submission (Investigational New Drug application) with the United States Food and Drug Administration (FDA) for a rheumatoid arthritis (RA) indication. In March 2009, Arana announced the successful completion of a phase II psoriasis trial with ART621 with repeat doses of ART621 being well tolerated and exhibiting a safety profile consistent with anti-TNF activity.

Arana has two ongoing trials in RA: a small pilot study (study ART621/223) and a 200 patient formal dose ranging study (study ART621-221).

Psoriasis in a pre-treatment Phase II participant