Biotec Pharmacon is pleased to inform that all data management procedures have been completed, and that the databases have been locked in both of the company’s phase III studies with soluble beta-1,3/1,6 glucan (SBG) for treatment of diabetic foot ulcer. No further data will be added. Two clinical research organizations will start to analyse the data. The timing of the database lock is consistent with previous communication, and Biotec Pharmacon expects to provide final study results during the fourth quarter 2009.
Both of the two phase III studies are randomized, double-blind, ”placebo” controlled studies to assess the efficacy and safety of SBG. The studies included 122 and 133 patients, respectively, and were initiated in June 2007 and October 2008. Patient treatment and follow-up was completed during the third quarter 2009. Provided positive and confirmatory results Biotec Pharmacon plans to submit an application for market authorisation in Europe next year, and has been allocated a slot with the UK authorities (MHRA) in July 2010. The UK will act as reference member state in a decentralized procedure and coordinate the review of an application submitted simultaneously in EU/EAA member states.
SBG targets a potentially large patient group. On an annual basis, an estimated 3.5 million of a total 70 million diabetes patients in the OECD-area develop foot and leg ulcers. These ulcers frequently develop into a chronic condition with high risk of infection and are a frequent cause of amputation in patients with diabetes. Biotec Pharmacon’s SBG reactivates immune cells in the skin and thereby enhances the body’s own wound healing capabilities. Today there are no standard well established treatments available beyond general wound care.
