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For Prevention Of Delayed Graft Function In
Kidney Transplant
Recipients
PRO-301 (iCO for DGF) is a P2b-ready product candidate with the potential to reduce incidence of delayed graft function (DGF) and improve outcomes in kidney transplant recipients. Development to date has been supported by >$30M in NIH/DoD Awards to develop the delivery device & conduct P1/2a trials in IPF, ARDS & PAH
Doubles chances of organ
rejection, reduces graft survival chances (52% to 32% over 13 yrs) Adds an average of six days to
post-transplant hospitalization (>$20K direct costs)Lower quality organs are at higher risk for DGF, which necessitates strict organ selection criteria, limiting usable organ pool.
iCO for DGF can reduce follow-up costs and improve outcomes for the ~30k annual cadaveric kidney transplants in the US/EU. If demonstrated effective, iCO could also expand the eligible organ pool by enabling use of previously excluded organs.
| Species | CO Dose | [CO Hb] | Outcome | Reference |
|---|---|---|---|---|
| Pig | 2-3 mg/kg, 1hr | 8-10% | improved graft function,reduced fibrosis | Hanto et al , (2010) |
| Rat | 250 ppm for 1 h pre-tx & 24 h post-tx | 25.3 ± 2.0% | improved survival and function,reduced inflammation and cell death | Neto et al , (2004) |
| Rat | 20 ppm for 30 days post-tx | -10% | Reduced inflammation, improved graft function,reduced chronic allograft nephropathy | Neto et al , (2006) |
| Rat | 100 mg/kg (as methylene chloride) | 5.5 ± 2.1% | Reduced chronic allograft nephropathy | Martins et al , (2004) |
| Rat | 250 ppm for 1 h pre-tx & 25 h post-tx | 20.5 ± 5.9% | Reduced immune response, improved function and survival, reduced immune response and chronic allograft vasculopathy | Falao et al , (2008) |
