Biotec Pharmacon: Patient inclusion started in phase III Oral Mucositis study
Patient inclusion has commenced as planned in the first of two phase III studies for the use of Biotec Pharmacon's SBG in patients with oral mucositis. This is a common and potentially severe side-effect of radiotherapy for cancer, in particular for head and neck cancers. Biotec Pharmacon expect to start patient inclusion in a second phase III study of oral mucositis later in the fourth quarter, with a target to file for marketing applications for SBG for this indication mid-2010. Biotec Pharmacon's SBG (soluble beta-glucan) is an immune stimulating drug which is intended for both prevention and treatment of oral mucositis.
The first patient was included at a hospital in Spain, which is one of approximately 20 study centres in three countries included in the program. Biotec Pharmacon has now received approval to start patient inclusion in the majority of the other centres. The current phase III study is designed for a population of 120 patients, with results expected to be ready for analysis at the end of 2009.
The phase III program design is based on discussions with the European Medicines Agency (EMEA) in 2007, and Biotec Pharmacon intends to apply for marketing authorisations in Europe in mid-2010.
The second phase III -study of oral mucositis will be carried out in four countries in Eastern Europe, and patient inclusion is expected to commence late in the fourth quarter.
Biotec Pharmacon is also in phase III for the use of SBG in patients with diabetic ulcers. Patient inclusion is well underway in the first of these studies, and an interim analysis assessing the potential need for adjustments of the sample size (120 patients) will be ready in November. Patient inclusion in the other phase III diabetic ulcer study is scheduled to commence later in the fourth quarter, and as for oral mucositis the company's objective is to file for a marketing authorisation for SBG in patients with diabetic ulcers in mid-2010.
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