Regenerex

Suzanne Ildstad, M.D., CEO
Louisville, KY
(Private)
Regenerex, an innovative, late clinical-stage cellular therapy company, is developing its FCRx platform technology with the goal of eliminating the burden of chronic immunosuppression in select organ transplant and severe autoimmune conditions. In an ongoing Phase II study, the company’s proprietary allogeneic cell therapy product, FCR001, has been shown to induce tolerance in recipients of solid organ transplants from unmatched and unrelated donors, allowing living donor kidney transplant recipients to wean completely off immunosuppression one year after transplant. FCR001 Phase II subjects achieved these results utilizing nonmyeloablative conditioning which minimizes toxicities typically associated with a standard Hematopoietic Stem Cells (HSC) transplant. FDA has granted Regenerex clearance to proceed with a pivotal Phase III study in Living Donor Kidney Transplant. FDA has also granted FCR001 Orphan Drug designation and Regenerative Medicine Advanced Therapy (RMAT) designation. www.regenerex.com