Date: 2011-01-24
Type of information: Initiation of preclinical development
phase: preclinical
Announcement: interim data report from the second animal study in diabetic mice
Company: Biotec Pharmacon (Norway)
Product: SBG
Action mechanism:
Disease: wound healing
Therapeutic area:
Country:
Trial
details: The results confirm the finding from the first study showing that a 2% aqueous solution of SBG has good wound healing capability. An important goal with the second study was to investigate different concentrations of SBG, and SBG in combination with an additional gel agent. Preliminary stability data has indicated that a mixed formulation would have increased stability as compared to a pure 2% aqueous solution of SBG. Also, different commercial hydrogels typically used in wound healing was included.
The results showed that SBG successfully can be mixed with different gel agents, and results also indicate that such mix improves the wound healing capability of the product. The best results were obtained with a combination of 2% SBG and carboxymethylcellulose (CMC), the latter being used in several of the commercial wound treatment hydrogels on the market, like Intrasite from Smith & Nephew and in the wound healing drug Regranex. This combination product of SBG and CMC induced statistically significant improved wound healing from day 12 and onwards throughout the study (day 24) only paralleled by the positive control. The results also confirm that such a SBG based product performs better than the other commonly used hydrogels containing CMC tested and also methylcellulose that was the placebo of the clinical studies.
As earlier reported, it was observed that a pure 2% aqueous solution of SBG when stored in aluminum tubes or polyethylene ampoules, were very sensitive to accelerated storage conditions as seen by early fragmentation of the gel. These two container types were accordingly chosen for the ongoing stability program to secure rapid progress in testing the new formulations. Preliminary data from the accelerated stability studies have so far indicated that the stability of SBG can be significantly improved. Either by increasing the concentration of SBG alone above 2% in water, resulting in a more solid gel, or by mixing SBG with an additional gel agent like CMC.
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