Biotec Pharmacon will proceed as planned with its first phase III study with SBG for oral mucosits, following the recommendation from an independent statistician who has performed an interim analysis based on the first 92 randomized patients in the study. Biotec Pharmacon has already included 123 of a total 130 patients in the study, and expects to have results ready in the first quarter 2010 as planned.
Biotec Pharmacon commissioned the interim analysis in April, with an objective to reassess the size of the patient population. The independent statistician has in a blinded fashion assessed the difference in response between two patient groups, one which has been treated with SBG and one which has been given a non-active compound as comparator (“placebo”). The recommendation to proceed as planned means that the study should be able to demonstrate a significant difference between the two groups, in either direction, or that the difference is so small that it would not become significant even with a substantial increase in the patient population.
“We are very close to reaching the target inclusion, and should be on track to complete patient follow-up and deliver data early next year. SBG has the potential to add significant value for the many patients with head and neck cancers who suffer from oral mucositis, and may also play an important role in preventing the damage to the mucosa. We are all looking forward to seeing the final results from the study,” says Professor Jean Bourhis, MD, PhD, coordinating investigator at the Gustave Roussy Cancer Centre outside Paris, France.
Oral mucositis is a common, very painful and potentially serious side-effect of radiotherapy (with or without chemotherapy), in particular for head and neck cancers. It develops as a result of damage to 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 already has “orphan drug designation” in Europe for oral mucositis in patients with head and neck cancer treated with radiotherapy. This may open up for improved protection from competitors, assuming the company obtains market authorization.
“The results from this study will be decisive for the way forward with SBG for this condition. We will consider continuing with a second phase III study but have earlier received signals that one study might be enough to apply for market authorization if the results are compelling,” says CEO Lars Viksmoen in Biotec Pharmacon ASA.
Biotec Pharmacon also has two phase III studies ongoing 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 mid-2010. This may open an even larger market opportunity, as one in six of the more than 250 million adult patients with diabetes at some stage will develop a foot ulcer. As for oral mucositis, no standard drug treatments are established other than general wound care.
