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hVEGF-A

Phase 1

Diabetic Neuropathy | Gene therapy | Neurology |Sangamo Therapeutics, Inc.|Last Updated: Jun 8, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00110500Clinical Trial of SB-509-0401 in Subjects With Diabetic NeuropathyPHASE1 COMPLETED 12Apr 1, 2005Jan 1, 2008Jun 8, 20111 United States
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Study Endpoints
Primary Endpoints
To evaluate the clinical and laboratory safety of SB-509 when given as a single treatment by an intramuscular injection
To determine the maximum tolerated dose (MTD) of a single treatment by intramuscular injection by SB-509.
Secondary Endpoints
To evaluate the lower extremity clinical effects of SB-509 treatment on lower limb diabetic neuropathy by symptoms, neurological examination, and lower extremity electrophysiological testing.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingSINGLE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
hVEGF-AGENETIC -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Have a clinical diagnosis of Diabetes Mellitus Type I or II for at least 12 months prior to the study. * Have received a diagnosis of mild to moderate sensori-motor diabetic neuropathy from a neurologist (a doctor who specializes in disorders of the nervous system) or endocrin...

Countries:United States
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