IBsolvMIR can improve the effects of cell therapy

Cell therapies are associated with graft loss due to an instant blood-mediated inflammatory reaction (IBMIR). This reaction 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.

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Developed to improve islet cell transplantation for treatment of patients with severe diabetes and chronic pancreatitis
Suitable for use with several cell types
Applicable to a range of regenerative cell therapies
Improves viability of engrafted cells resulting in higher efficacy and improved patient outcomes

PROGRESS

Phase1
Phase2
Phase3
Phase4

Development phases

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.

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Reported benefits

Independent studies have demonstrated that IBsolvMIR: