Biotec Pharmacon: Phase III diabetic ulcer program proceeds as planned after interim analysis
The independent statistician responsible for the interim analysis of the second of the two phase III studies with SBG for diabetic foot ulcers recommends that Biotec Pharmacon proceeds as planned with the study. As no adjustments are being made to sample size, patient enrolment is already completed. The company expects to have final results for both its phase III studies towards the end of the year, and is on track to file for marketing authorization with SBG for treatment of diabetic foot ulcer in Europe in mid-2010.
Biotec Pharmacon commissioned the interim analysis in March, with an objective to reassess the size of the patient population. The independent statistician has measured the difference in response between two patient groups, one which has been treated with SBG and one which has been given a non-active compound as comparator ("placebo"). Both groups have also received general wound care. The recommendation to proceed as planned means that either the results for the two groups are significantly different, in either direction, or the difference is so small that it would not become significant even with a substantial increase in the patient population. The company in November last year received the same recommendation after the interim analysis of the first phase III study with SBG for diabetic foot ulcer.
"We believe this is good news. Since we already have enrolled the planned number of patients in both our phase III studies, the clinical centers can now focus on treatment follow-up of the last patients over the next few months. We have to allow some time for data collection and analysis, but are confident that we will have the study results ready for both studies by the end of the year. Positive, confirmative results from two phase III studies are considered sufficient to file for marketing authorization," says CEO Lars Viksmoen in Biotec Pharmacon.
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