The company expects to have data from this trial in the second half of 2008. This Phase II trial followed a positive Phase I study that demonstrated clinical safety of a single treatment with SB-509 as well as statistically significant improvements in quantitative sensory testing, clinically relevant improvements in motor and sensory nerve conduction velocities and a trend towards improvement in total neuropathy score (TNS), suggesting an alteration of disease progression in subjects with DN. The Phase II study was designed to confirm and expand these findings and to evaluate repeat dosing with SB-509.
The trial has been partially funded by a $3 million commitment from the Juvenile Diabetes Research Foundation International (JDRF) pursuant to a research agreement between Sangamo and JDRF. Completion of enrollment of the trial triggers a milestone payment from JDRF under this agreement.
Edward Lanphier, president and CEO of Sangamo, said: “We have been very encouraged by the disease-altering improvements that we observed in our preclinical studies and in the Phase Ib trial and look forward to presenting the data from this current study by the end of 2008.”