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evaluate the effect of intramuscular administration of SB-509 on the
progression of the disease in subjects with ALS. In addition to
gathering data on safety and tolerability of SB-509, the study will
also evaluate stem cell mobilization in subjects with ALS receiving
SB-509.
* Presentation of additional data from Phase 1b study of SB-509
(SB-509-401) and interim data from Phase 2 study (SB-509-701) in
subjects with diabetic neuropathy (DN). Additional data from the
Phase 1b clinical trial (SB-509-401) were presented at the 44th Annual
Meeting of the European Association for the Study of Diabetes (EASD),
demonstrating a statistically significant (p=0.0016) positive
correlation of 2 or more response endpoints in the SB-509 treated group
compared with placebo treated subjects at day 180 post-treatment.
Response endpoints were defined as greater than a 14% improvement in
quantitative sensory testing (QST), greater than 0.8 meters/second
(m/sec) improvement in NCV and greater than a 3 point improvement as
judged by the Neuropathy Impairment Scale - Lower Limbs (NIS-LL). The
trial was conducted in subjects with mild to moderate diabetic
neuropathy over a six month period after a single administration of
SB-509. Positive interim clinical data were also presented at the
International Society for Cellular Therapy (ISCT) Europe Regional
Meeting in Antwerp, Belgium from the Phase 2 trial of SB-509
(SB-509-701) conducted in subjects with moderate to severe DN who
entered the trial with at least one "blocked nerve". The data
demonstrate recovery of sensory nerve conduction velocity (NCV) in 75%
of SB-509 treated subjects compared to 25% of placebo treated subjects.
SB-509 is an injectable formulation of plasmid DNA tha
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