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150M PLX-PAD

Phase 1

Total Hip Arthroplasty | Monoclonal antibody | Other |Pluri Inc.|Last Updated: Sep 21, 2015

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01525667Safety and Efficacy of IM Injections of PLX-PAD for the Regeneration of Injured Gluteal Musculature After Total Hip ArthroplastyPHASE1 COMPLETED 20 — — Nov 1, 2012Jun 1, 2015Sep 21, 20151 Germany
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Study Endpoints
Primary Endpoints
Change From Day 0 to Week 26 in the Maximal Voluntary Isometric Contraction (MVIC) Moment of the Injured Side to Assess Gluteus Medius Strength.
Day 0 to Week 26

Change from Visit 2 (Day 0) to Week 26 in the maximal voluntary isometric contraction (MVIC) moment of the injured side as measured by isometric dynamometry to assess Gluteus Medius force strength.

Secondary Endpoints
Change From Day 0 to Week 26 in Muscle Volume.
Day 0 to Week 26
Change From Day 1 to Week 12 in Mean Fiber Diameter.
Day 1 to Week 12
Change From Day 0 to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift .
Day 0 to Week 26
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
150M PLX-PADEXPERIMENTALSingle course, multiple IM injections
300M PLX-PADEXPERIMENTALSingle course, multiple IM injections
PlaceboPLACEBO_COMPARATORSingle course, multiple IM injections
Interventions
NameTypeDescription
150M PLX-PADBIOLOGICALSingle course, multiple IM injections
300M PLX-PADBIOLOGICALSingle course, multiple IM injections
PlaceboBIOLOGICALSingle course, multiple IM injections
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Eligibility Criteria
Age Range50 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Male or female subjects between 50 to 75 years of age 2. Scheduled THA 3. ASA Score ≤ 3 4. Signed written informed consent Exclusion Criteria: 1. Muscle diseases 2. Severe neurological diseases 3. Opioid long term medication 4. Pain chronification \> stadium II of Gerbersha...

Countries:Germany
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