ved a single treatment in both
legs of either placebo (12 subjects) or SB-509 (12 subjects who received 60
mg total dose, 30 mg per leg). All of the subjects completed 6-month
follow-up testing. SB-509 was well tolerated and no drug-related severe
adverse events were observed. Clinically relevant and statistically
significant improvements were seen in neurologic examination using the
Neurological Impairment Score - Lower Limbs (NIS-LL) and quantitative
sensory testing (QST) which quantifies perception of vibration. In
addition, there was a trend towards improvement in nerve conduction
velocity (NCV), a measure of the ability of a nerve to transmit an applied
electrical signal, in both sensory and motor nerves.
Specifically, improvement in neurologic evaluation by NIS-LL in
SB-509-treated subjects was measured as a statistically significant,
clinically relevant improvement of 1.9 point change from baseline levels
compared to a 0.7 point worsening in the placebo group (a delta in NIS-LL
of 2.6, p=0.043). In addition, there was a 25.3% improvement in detection
of mechanical sensation compared to baseline, as measured by QST testing,
in SB-509-treated patients compared to a 5.1% worsening in the placebo
group (a delta in QST of 30.4%, p=0.02). The mean improvement in sensory
(sural) NCV measurements 180 days post treatment was 1.2 Meters/sec with
SB-509 treatment compared to -0.4 Meters/sec with placebo (a delta in NCV
of 1.6 Meters/sec). The mean sum of improvement of all lower extremity
motor NCV measurements 180 days post treatment was 0.8 Meters/sec with
SB-509 treatment compared to -0.9 Meters/sec with placebo (a delta in NCV
of 1.7 Meters/sec).
While the primary end-point of Sangamo's Phase 1b study (SB-509-401)
was safety, data were also collected that were designed to measure changes
in neurological health. Quantitative sensory testing (QST) using the
Vibratron II is used as a method of assessing a subject's change in
vibration sensitivity. Direct
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SOURCE Sangamo BioSciences, Inc. Copyright©2008 PR Newswire. All rights reserved | |
Page: 1 2 3 4 5 6 7 8 9 Related medicine technology :1.
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