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PLX-PAD Low dose

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment180

FDA Designations

No designations recorded

Clinical trial landscape

PLX-PAD Low dose · 1 trial · 2 indications

Phase 2 1
NCT01679990Safety and Efficacy of Allogeneic Cells for the Treatment of Intermittent Claudication(IC)Intermittent Claudication
COMPLETED180 Analytics
PHASE2COMPLETED
Safety and Efficacy of Allogeneic Cells for the Treatment of Intermittent Claudication(IC)
Intermittent ClaudicationUnlock trial analytics

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 to 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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Frequently asked questions about PLX-PAD Low dose

What is PLX-PAD used for?

PLX-PAD is an investigational cell therapy being studied for Critical Limb Ischemia (CLI), Intermittent Claudication, Hip Fracture, and Peripheral Artery Disease. It is administered by intramuscular injection and is being developed by Pluri Inc. (PLUR). The drug is currently in Phase 3 clinical trials.

What does PLX-PAD target?

PLX-PAD is a placental-derived cell therapy, not a monoclonal antibody. It is designed to promote tissue repair and regeneration in ischemic conditions such as Critical Limb Ischemia and Peripheral Artery Disease. The therapy works by delivering allogeneic cells that support angiogenesis and muscle recovery.

Who makes PLX-PAD?

PLX-PAD is being developed by Pluri Inc., a biopharmaceutical company traded on the stock exchange under the ticker PLUR. The company is conducting Phase 3 clinical trials for the treatment of Critical Limb Ischemia and Hip Fracture.

What phase is PLX-PAD in?

PLX-PAD is currently in Phase 3 clinical development. It has completed two Phase 1 safety trials and two Phase 3 efficacy trials. The drug is investigational and has not been approved by regulatory authorities for any indication.

What clinical trials is PLX-PAD in?

PLX-PAD has completed several clinical trials, including NCT00919958 and NCT00951210, which were Phase 1 safety studies in Critical Limb Ischemia. Phase 3 trials include NCT03006770 for Critical Limb Ischemia with minor tissue loss and NCT03451916 for muscle injury following hip fracture surgery.

Is PLX-PAD the same as PLX-PAD cells?

Yes, PLX-PAD is also referred to as PLX-PAD cells in clinical trial documentation. The drug is an allogeneic cell therapy derived from placental cells, and the terms are used interchangeably in the context of its development for peripheral artery disease and related conditions.