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 into 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 help cells pass through the lung and reach their intended site and once there, it promotes the formation of new vessels and engraftment.
Science
Features
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
Reported benefits
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).
Pipeline for IBSOLVMIR
Development phases
IBSOLVMIR is well documented in several safety and toxicology studies. Efficacy has been reported in a low-dose Phase 2 study.
For more information, please refer to www.clinicaltrials.gov
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.
Ongoing clinical studies
TikoMed is currently performing a phase 2 clinical study in islet transplantation for brittle diabetes patients. The study will include 18 patients, 12 receiving islet transplantation in combination with TikoMed’s drug IBSOLVMIR and 6 patients in a control group receiving standard of care.
Centers included are Huddinge Hospital, Uppsala University and Oslo University Hospital. PI is Torbjörn Lundgren, MD, PhD.