�Biota Holdings Limited (ASX:BTA)(PINK:BTAHY) announced the commencement of dosing in the first base Phase IIa challenge report of BTA798, an orally delivered and potent inhibitor of human rhinovirus (HRV). HRV is the major cause of the unwashed cold and is associated with clinical complications for patients with asthma, cystic fibrosis, continuing obstructive pulmonic disease or a compromised immune use.
The purport of the Phase IIa study is to assess BTA798 for the bar (prophylaxis) of HRV infection in or so 200 intelligent volunteers. Each volunteer volition be administered either placebo or i of trey 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 volition also be monitor! ed to provide further information on BTA798.
The results o! f this a nd 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.
About Phase IIa challenge studies
Challenge studies with antiviral agent drugs expose volunteers to both an induced infection and the drug under study. Challenge studies may examine the efficacy of the drug to either treat the infection (therapy) or prevent the infection (prophylaxis) and the potency of the drug normally is deliberate by compare to a placebo . Therapeutic challenge studies require the infection to be naturalized before do drugs treatment and prophylactic challenge studies ask the commencement of do drugs treatment before exposure to the induced infection.
Volunteers included in challenge studies must be both he! althy and potentially susceptible to the induced infection.
Biota's initial trial is a prophylaxis study with volunteers exposed to HRV infection by intranasal inoculation.
About human rhinovirus, including in Asthma & COPD
Rhinoviruses can causal agency up to 50% of all adult colds, and are the predominant cold virus in children. In otherwise healthy individuals, rhinovirus infections ar a nonaged inconvenience and are self limiting, although 75% of common colds suffered by children under 5 years of historic period in the US, are medically tended to.
However, HRV is a major cause of hospitalization and respiratory distress in individuals with chronic fundamental respiratory conditions, including bronchial asthma and COPD sufferers.
It is estimated that rhinovirus is associated with or so 70% of all asthma exacerbations and more than 50% of the hospitalised cases. Although the actual costs of viral exacerbations in asthma attack have not been ! measured, they appear to put up significantly to the tot up! cost of the disease, as they represent some 80% of exacerbations in children and between 40% and 76% in adults.
Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading cause of death in the US. An estimated 10 million adults were diagnosed with COPD in 2000, while a national health survey suggests that as many as 24 million Americans ar affected. In 2000, 119,000 deaths, 726,000 hospitalisations and 1.5 million hospital emergency department visits were caused by COPD in the US. Studies suggest that respiratory viruses ar associated with more than 35% of acute exacerbations of COPD requiring hospital care.
About Biota Holdings Limited
Biota is a leading anti-infective drug development company based in Melbourne Australia, with key expertise in respiratory diseases, particularly influenza. Biota developed the first-in-class neuraminidase inhibitor, zanamivir, subsequently marketed by GlaxoSmithKline as Relenza.
Biota res! earch breakthroughs make included a series of candidate drugs aimed at treatment of respiratory syncytial virus (RSV) disease, accredited to MedImmune Inc. and novel nucleoside analogues designed to treat hepatitis C virus (HCV) infections, accredited to Boehringer Ingelheim. Biota has clinical trials underway with its lead deepen for human rhinovirus (HRV) infection in patients with compromised internal respiration or immune systems. In addition, Biota has a key partnership with Daiichi-Sankyo for the development of second propagation influenza antivirals. Inverness Medical markets Biota's co-developed OIA FLU flu diagnostics.
Relenza(tm) is a registered trademark of the GlaxoSmithKline radical of companies.
BioStar(R) OIA(R) FLU and BioStar(R) OIA(R) FLU A/B are registered trademarks of Inverness Medical.
Biota Holdings Limited
View drug information on Relenza.
More info
