For Immediate Release Melbourne, Australia — 11 August 2008 Human rhinovirus Phase IIa clinical trial commences Biota Holdings Limited (ASX:BTA) today announced the commencement of dosing in the first Phase IIa challenge study of BTA798, an orally delivered and potent inhibitor of human rhinovirus (HRV). HRV is the major cause of the common cold and is associated with clinical complications for patients with asthma, cystic fibrosis, chronic obstructive pulmonary disease or a compromised immune function. The aim of the Phase IIa study is to evaluate BTA798 for the prevention (prophylaxis) of HRV infection in approximately 200 healthy volunteers. Each volunteer will be administered either placebo or one of three dose levels of BTA798 before being exposed to an experimental rhinovirus infection. The double-blind study will be conducted in a controlled quarantine facility in the UK and will monitor the clinical endpoints of viral count and cold symptom improvement. Drug safety and pharmacokinetics will also be monitored to provide further data on BTA798. The results of this and subsequent Phase IIa studies will be used to assist in selecting doses for treatment and prevention of HRV infection in later clinical studies. Dosing is expected to be completed by December/January, subject to adequate enrolment rates with volunteers. The full results are expected by the end of April 2009.
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