Biotec Pharmacon has included 130 patients and reached the planned number of patients in its phase III study with SBG for prevention and treatment of oral mucositis.The study results are expected to be ready in the first quarter 2010, after which Biotec Pharmacon will decide on the final plan to file for market authorization for SBG for this indication.
Depending on the results, Biotec Pharmacon will consider carrying out a second phase III study. The company has earlier received signals that one study may be enough to apply for market authorization, contingent compelling results.
Oral mucositis is a common, very painful and potentially serious side-effect of radiotherapy (with or without chemotherapy), in particular with head and neck cancers. It develops as a result of damage to mucosal epithelial and immune cells inflicted by the cancer therapies. Approximately 400,000-600,000 incidents of oral mucositis are annually reported in the OECD area, and no standard treatment has been established. Biotec Pharmacon’s value proposition is that SBG both can stimulate the immune system to prevent development of severe oral mucositis and support healing of the condition by enhancing the body’s own wound healing capabilities. The company has already obtained an “orphan drug designation” in Europe for oral mucositis in patients receiving radiotherapy for cancers in the head- and neck region. This may offer improved protection from competitors if and when the company obtains market authorization.
A decision was made earlier in August to stop patient inclusion as planned after 130 patients. This was based on an interim analysis carried out by an independent statistician, who in a “blinded” fashion measured the difference between two patients groups; one treated with SBG and one given a non-active substance.
Biotec Pharmacon also completed patient inclusion in two phase III studies with SBG for treatment of diabetic foot ulcer. Results from these studies are expected by the end of the year and the company is preparing to file a market authorization application for this indication in Europe in July 2010.
