IBsolvMIR can improve the efficacy in cell therapy
Cell therapies are associated with graft loss. It involves activation of the complement and coagulation cascades when cells come in to contact with blood, ultimately resulting in cell death. IBsolvMIR is an infusion product that inhibits IBMIR and alleviates its detrimental effects when administered during transplantation. In addition, IBsolvMIR helps cells pass through the lung and reach their intended site and once there, it promotes the formation of new vessels and engraftment.
IBsolvMIR is well documented in several safety and toxicology studies. Efficacy has been reported in a low-dose Phase 2 study and high-dose follow-up studies are planned.
Completed clinical studies
Patients with severe diabetes were treated with IBsolvMIR at the time of islet transplantation surgery. They showed improvement to the same extent as compared to the maximum dose treatment with heparin.
IBsolvMIR has been administered to 69 healthy volunteers and 10 patients with severe diabetes, without drug-related safety concerns.
Planned clinical studies
Doses used during completed clinical studies were very low due to safety restrictions and not optimal. Follow-up studies are planned with an improved dose regimen to achieve increased islet survival and insulin independence.
Independent studies have demonstrated:
- Improved in vitro viability of islet cells (Naziruddin 2014).
- Improved survival of EPO producing CHO cells (Menviele et al 2013).
- Improved survival and engraftment of HSC in mice (Hayakawa et al 2009).
- Inhibition of the ability of human islets to trigger IBMIR (Johansson et al 2006).
- Reduces entrapment of T-cells in the lung
- Improved survival of engrafted myoblasts in mice (Laumonier et al 2013).
- Increased the survival of grafted adult porcine islets after intraportal transplantation into diabetic athymic mice (Goto et al 2004).