29-06-2012: Bioxyne Limited has received the preliminary analysis of the study 005 which examines the efficacy and safety of the immunotherapeutic, HI 164 OV in patients with chronic obstructive pulmonary disease (COPD).
The study recruited 320 patients from 21 sites around Australia. At study’s end 287 patients completed the study. From previous, much smaller studies, particularly study 002, the immunotherapeutic suggested it reduced the exacerbations common in this disease, and the risks of hospitalization in patients with more severe disease.
The Company, together with the Clinical Research Organisation managing the clinical study, and other professional advisers, has undertaken an extensive assessment of the data pack emerging from the study. The outcome is complex, and that has required the Company, and its professional advisers, to undertake a number of additional analyses to better understand the results.
The findings from the study were:
- When the complete patient cohort is analysed there was no benefit in reducing either exacerbations or hospitalisations for the active group.
- A subset of the test group, patients under the age of 65, however, demonstrated significant benefits attributable to HI 164 OV. These included:
- Hospitalisations associated with exacerbations were reduced by 50%
- Days in hospital associated with exacerbations were reduced by 65%
- Time to the first exacerbation was extended by a significant time
- Number of corticosteroid treatments were reduced by a significant amount
- HI 164 OV was a safe product when used in this group of COPD patients