The Turku Science Park -based drug development company BioTie Therapies announced, that top-line data from the first-in-man study with Biotie's fully human VAP-1 monoclonal antibody BTT-1023 have become available. The study was conducted in a clinical pharmacology unit in the United Kingdom and investigated the safety, tolerability and pharmacokinetic characteristics of single intravenous doses of BTT-1023 in healthy volunteer subjects.

A total of 35 subjects, of whom 29 received BTT-1023, were enrolled into the placebo-controlled study. BTT-1023 was generally well tolerated and no serious adverse events were reported in the study. Among the five subjects who received the highest dose, facial flushing was reported by two subjects with accompanying facial oedema in one of the two. These were reported during or shortly after the infusion and are not uncommon events in association with intravenous administration of therapeutic protein drugs. No cytokine release or fever was observed in any subject. All adverse events were fully reversible and required no particular intervention.
 
The data from the study support proceeding to clinical studies with repeated doses of the antibody. These studies are expected to be carried out in rheumatoid arthritis and psoriasis patients and will aim to establish appropriate dosing regimens for subsequent therapeutic studies and provide initial information on the therapeutic potential of BTT-1023. The studies are expected to start in the end of 2008.

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