In April 2018, Pluristem announced that the FDA had given two pipeline programs IND clearance: PLX-PAD for femoral neck fracture (FNF) healing and PLX-R18 for acute radiation syndrome (ARS). The company plans to initiate the Phase III trial investigating PLX-PAD for FNF healing later this year. IND approval of the PLX-R18 program allows for potential use of the product in the event of radiological emergencies for investigational purposes, which could provide in-human data.
29 May 2018
Pluristem Therapeutics - FDA gives two programs the green light with IND
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Pluristem Therapeutics - FDA gives two programs the green light with IND
In April 2018, Pluristem announced that the FDA had given two pipeline programs IND clearance: PLX-PAD for femoral neck fracture (FNF) healing and PLX-R18 for acute radiation syndrome (ARS). The company plans to initiate the Phase III trial investigating PLX-PAD for FNF healing later this year. IND approval of the PLX-R18 program allows for potential use of the product in the event of radiological emergencies for investigational purposes, which could provide in-human data.