Emiplacel is under clinical development by Pluri and currently in Phase III for Muscle Injury. According to GlobalData, Phase III drugs for Muscle Injury does not have sufficient historical data to build an indication benchmark PTSR for Phase III. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Emiplacel LoA Report. Buy the report here.
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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Emiplacel overview
Emiplacel (PLX-PAD) is under development for the treatment of critical limb ischemia, graft versus host disease (GVHD), muscle injury following arthroplasty for hip fracture, mild to moderate knee osteoarthritis (OA). It is administered as intramuscular injection and intravenous infusion. The stem cell therapy is based on PLX (placental expanded) cells drug delivery platform that releases a cocktail of therapeutic proteins in response to a variety of local and systemic environmental signals. They are expanded using company's proprietary three dimensional (3D) bioreactor systems.
It was also under development for Buerger's disease, ischemic heart disease, diastolic heart failure, pulmonary fibrosis, pulmonary arterial hypertension, Duchenne muscular dystrophy, COVID-19 infections intermittent claudication and pre-eclampsia.
Pluri overview
Pluri, formerly Pluristem Therapeutics Inc, is a clinical-stage biotherapy company that focuses on the development of placental-derived cell therapies. The company’s placental expanded cells are adherent stromal cells that can be administered to patients without tissue or genetic matching. Pluri’s product pipeline includes PLX-PAD for critical limb ischemia, intermittent claudication, orthopedic conditions, pulmonary arterial hypertension and women’s health. The company’s PLX-Immune for kidney, colorectal, breast, lung, muscle, skin and liver cancers, PLX-R18 for hematological system and acute radiation syndrome. Pluri harnesses its proprietary 3D cell expansion platform technology for developing its cell therapies. It works in partnership with medical, pharmaceutical and academic institutions. Pluri is headquartered in Haifa, Israel.
For a complete picture of Emiplacel’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
