Published 22.02.2010

Biotec Pharmacon has received data showing that SBG failed to show superiority over placebo in the phase III study for oral mucositis. Newly available biological activity assays indicate that SBG used in the diabetic ulcer program may have been inactivated as a result of interaction with polyethylene in the product containers. The company plans to carry out accelerated stability studies of SBG with alternative containers.

“We are not overly surprised by the results from the oral mucositis study, given the outcome of the diabetic ulcer studies in November last year. As with the diabetic ulcer studies, there was no statistically significant difference between the two treatment groups, although a marginal advantage of SBG over placebo was seen for the primary endpoint”, says CEO Lars Viksmoen.

Biotec Pharmacon has since late November worked to identify the root cause behind SBG failing the phase III diabetic ulcer program. “We’re clearly dealing with a systematic failure”, says Viksmoen. “There is nothing wrong with our SBG manufacturing process or with the design and conduct of the clinical trials. However, we have early evidence that there has been an unexpected interaction between the product container and SBG that has led to inactivation of SBG over time”.

Such interaction could not be discovered by the assays available at the start of the studies but development of new biological assays has revealed a stability issue related to certain containers. “We need further confirmation of this theory, and are now planning to conduct similar analyses with the product used in the phase III oral mucositis studies since the same type of containers have been used in all these studies. We are also planning to initiate accelerated stability studies with a number of different containers”, says Viksmoen, who expects the first results to be available by mid-2010.