The pharmaceutical development was advancing into finalizing phase III studies within treatment of diabetic ulcer and oral mucositis in 2009, however both these studies failed due to broken product and would need to be redone if SBG is to be developed into a drug for these indications. For a development of a medical device product based on the SBG technology a limited clinical study would need to be performed to meet the regulatory requirements.  Normally this will be a “equal or better than” study and the scope will be dependent of which medical devices classification it will obtain.

Currently a clinical phase I study on the combination of SBG with a cancer vaccine against neuroblastoma is running at Memorial Sloan Kettering Cancer Centre in New York. The early phase studies in cancer (breast cancer, Non-Hodgkin’s lymphoma, and neuroblastoma) combining SBG and anti-cancer antibodies all documented a very good safety and tolerability profile of the combination. A phase II clinical trial program is currently being investigated.