Biotec Pharmacon has completed patient enrollment in a double-blinded, therapeutic exploratory clinical phase II trial to evaluate the efficacy of its soluble beta-1,3/1,6-glucan (SBG) on chronic foot ulcers in diabetic patients. The trial, which is performed at hospitals in Archangelsk and St. Petersburg, Russia, involves 60 patients. Patient treatment and follow-up is expected to continue for approximately 16 weeks, and the data from the study will be reported in the fourth quarter this year.
Diabetic patients often suffer from complicated ulcers due to dysfunctional immune cells. Biotec Pharmacon’s concept for treatment of ulcers is based on the company’s pharmaceutical compound SBG which acts on immune cells to advance healing of the ulcers.
Biotec Pharmacon has already completed, with very good results, an open human pilot study with SBG in 20 patients with diabetic foot ulcers. In addition to the ongoing phase II study where patient inclusion now is completed, the company is also preparing a phase II trial at Nottingham City Hospital involving 104 patients.
Chronic wounds in diabetes patients represent a severe medical problem. Within OECD, an estimated 3 million diabetics are believed to be affected by ulcers, and there are few effective forms of treatments available today.
