Pro - 301

For Prevention Of Delayed Graft Function In
Kidney Transplant Recipients

PRO-301 (iCO for DGF)

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

DGF post-transplant is a major morbidity, mortality & cost driver:
  • 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.

Preclinical Kidney Transplant Studies
Demonstrating iCO Efficacy
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)