New clinical study for treatment of diabetic foot ulcers
Biotec Pharmacon has entered into an agreement with Nottingham City Hospital NHS Trust to perform a clinical phase II study entitled "A randomised, double-blind, placebo-controlled study to determine the efficacy of soluble beta-1,3/1,6-glucan in chronic foot ulcers in diabetes." A total of 104 patients will be included in the study.
The protocol for the study and the application to UK health authorities have been completed. The trial is likely to commence during the first half of 2006, pending approval by the Nottingham Research Ethics Committee and the Medicines and Health Care Products Regulatory Agency (MHRA).
Biotec Pharmacon's concept for treatment of ulcers is based on effect of the company's pharmaceutical compound SBG which acts on immune cells in the skin to advance healing of wounds and ulcers. Diabetic patients often suffer from complicated ulcers due to dysfunctional immune cells in the skin. SBG binds to and activates immune cells in such a way that new tissue develops.
Treatment of chronic ulcers is one of the priority therapeutic areas of Biotec Pharmacon based on it's pharmaceutical compound SBG. The other priority is immunotherapy of cancer where a clinical phase I/II study is ongoing at Memorial Sloan-Kettering Cancer Center in New York, and two studies are underway in Ullevaal University Hospital and Rikshospitalet-Radiumhospitalet in Oslo.
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