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PLX-PAD Low dose

Phase 2

Intermittent Claudication | Monoclonal antibody | Cardiovascular |Pluri Inc.|Last Updated: Feb 12, 2019

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment180
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01679990Safety and Efficacy of Allogeneic Cells for the Treatment of Intermittent Claudication(IC)PHASE2 COMPLETED 180Nov 5, 2012Feb 9, 2019Feb 12, 201934 United States, Germany +2
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Study Endpoints
Primary Endpoints
Log ratio of week 52 maximal walking distance(MWD)to baseline MWD
12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PLX-PAD Low doseEXPERIMENTALPLX-PAD double low doses
PLX-PAD high dosesACTIVE_COMPARATORPLX-PAD double high dose
PlaceboPLACEBO_COMPARATORDouble Placebo doses
PLX-PAD high dose +PlaceboEXPERIMENTALHigh dose+Placebo
Interventions
NameTypeDescription
PLX-PAD Low doseBIOLOGICAL -
PLX-PAD high dosesBIOLOGICAL -
Double PlaceboBIOLOGICAL -
high dose +PlaceboBIOLOGICAL -
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Eligibility Criteria
Age Range45 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites34

Inclusion Criteria: * Adult male or female subjects between 45 to 85 years of age (inclusive) at the time of screening visit. * Subjects with a diagnosis of peripheral artery disease, secondary to atherosclerosis, confirmed by one of the following criteria assessed at the screening visit: * Rest...

Countries:United StatesGermanyIsraelSouth Korea
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