Biotec Pharmacon has included 130 patients and reached the planned size in the second of its two phase III studies with SBG for treatment of diabetic foot ulcer. An interim analysis was initiated earlier in March to reassess the size of the patient population, with results expected by mid-May. Provided that no changes are being proposed, Biotec Pharmacon should have final study results in November or December and be on track to file for marketing authorization with SBG for treatment of diabetic foot ulcer in Europe in mid-2010.
“Patient inclusion has been very fast in the second study, with particularly strong enrolment at the clinical centers in Poland and Russia. The patients go through a twelve-week treatment period and patients with healed ulcers are followed up after another twelve weeks. Then we have to allow time for data collection and analysis but we should have results ready by year-end,” says CEO Lars Viksmoen in Biotec Pharmacon. He adds that the clinical centers will stay prepared to include more patients, if results from the ongoing interim analysis suggest that an increase of the patient population is necessary.
Patient inclusion in the first phase III study was completed earlier in March, with final results expected to be ready in the fourth quarter. An interim analysis of that study in the fourth quarter 2008 did not trigger any changes in the patient population. Positive, confirmative results from two phase III studies are considered sufficient to file for marketing authorization.
“We obviously are looking forward to present results from both our phase III studies for diabetic foot ulcer and believe SBG can offer a new and effective therapy for a large group of patients which has few good treatment options today,” says Viksmoen.
There are currently more than 250 million adults with diabetes in the world, and one in six of these will at some stage develop a foot ulcer. Untreated foot ulcers may develop into a chronic condition with high risk of infections, and some 15-25 percent of diabetic foot ulcer patients will eventually require amputation. No standard drug treatments are available, other than general wound care. Biotec Pharmacon’s immune stimulating drug SBG (soluble beta-glucan) reactivates immune cells in the patients’ skin and thus enhances the body’s own wound healing capabilities.
Biotec Pharmacon expects to file for market authorization in Europe mid-2010. In order to secure product availability in all major territories, partnering activities have been intensified. “Potential partners are showing a great deal of interest, as the anticipated solid safety and efficacy profile makes SBG a very attractive product,” states VP Business Development Sven Rohmann.
Biotec Pharmacon also has an ongoing phase III study with SBG for prevention and treatment of oral mucositis in patients with head and neck cancer, and is nearing completion of a phase I/II program with SBG for use in combination with monoclonal antibodies in immunotherapy of cancers. The company also has pre-clinical programs focusing on SBG-applications within inflammatory bowel diseases.
Learn more about facts on diabetic foot ulcers by clicking here.
