Sangamo BioSciences Announces Presentation of Phase 1b ZFP Therapeutic Data at American Diabetes Associati...(measurement of the speed and amplitude o...),Health

Date:6/8/2008

measurement of the speed and amplitude of an applied electrical impulse or nerve conduction velocity (NCV) in both sensory and motor nerves is a method of assessing the integrity or health of the nerve. A broader approach to quantification of clinical benefit involves the use of one of the many available composite scoring systems. These include the Total Neuropathy Score (TNS) and the narrower Neuropathy Impairment Score in the Lower Limbs (NIS-LL). The NIS-LL is a validated instrument that can be used to measure a clinically meaningful change in the neurological status of patients with DN over time. NIS-LL includes measures of motor and sensory nerve heath as well as reflex testing and is a quantifiable score of neurologic exam. These three measurements have all been used as primary or secondary endpoints of clinical benefit in Phase 3 studies.

"We are very encouraged by the safety of SB-509 and the improvements that we have seen in subjects with mild to moderate DN up to six-months after administration of a single dose of SB-509," stated Dale Ando, M.D., Sangamo's vice president of therapeutic development and chief medical officer. "Particularly interesting are the encouraging and correlative gains observed in the NIS-LL and QST measurements of treated subjects which are independent and confirmatory. Both NIS-LL and QST have been used as end-points in previous pivotal large scale trials of other non-analgesic approaches for diabetic neuropathy. "

From a safety perspective, the Phase 1b data were consistent with previous observations that a single treatment of SB-509 was well tolerated and that no drug-related severe adverse events were observed. Injection site reactions were the most common adverse events reported and were mild and reversible. Importantly, subjects in the study were treated within the pharmacologically effective dose range that was demonstrated to be efficacious in preclinical animal studies.

"Although the primary end-point of
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SOURCE Sangamo BioSciences, Inc. Copyright©2008 PR Newswire. All rights reserved

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