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.Pluristem Therapeutics is a developer of placenta-based cell therapy product candidates for the treatment of multiple ischemic, inflammatory and hematologic conditions. The company's product candidates include: PLX-PAD, which is in a multinational clinical trial in critical limb ischemia, and in a multinational clinical trial in recovery following surgery for hip fracture; PLX-R18, which is under development in the U.S. for acute radiation syndrome, as well as in a trial in the U.S. and Israel for incomplete hematopoietic recovery following hematopoietic cell transplantation; and PLX-Immune, which is under pre-clinical development for treatment of certain human cancer types.
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