29 May 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Australian company Bioxyne closed its 320-patient study, which was designed to evaluate the efficacy and safety of the Bioxyne's HI-164OV therapy for patients with chronic obstructive pulmonary disease (COPD). The company has confirmed to release the data, which is in the late stage of analysis, from its phase IIb trial in June.
The primary aim of the study is to assess the impact of treatment with HI-164OV in reducing severe exacerbations in COPD patients and reducing the need for admission to hospital. There are a number of measures of disease severity being examined that will define the profile and benefits of HI-164OV and its potential long term value.
Mr David Radford, CEO, Bioxyne, said that, "We are focused on ensuring accurate communication of the trial results and to also guard against partial and incomplete reporting of the results."
"Given the importance of the results, Bioxyne may consider a short-term trading halt during the period between our receipt of initial data through until the time when the company has formally assessed the final result and is able to accurately communicate these results to the market," he said.
The primary endpoint in the trial is a demonstration of a reduction in exacerbations requiring oral corticosteroid treatment or hospitalisation.
The secondary endpoints seek to determine if HI-164OV can reduce the severity of exacerbations, the number of patients experiencing exacerbations requiring corticosteroid treatment or hospitalisation and a reduction in the use of antibiotics and or corticosteroids. There have been no indications of patient-related safety issues during the trial.