TRACT Therapeutics has successfully completed the Phase I clinical trial utilizing the patient’s own T regulatory cells after a kidney transplant. There were no serious adverse events attributable to the treatment and additional data analyzed showed signals toward efficacy. A manuscript entitled “A Phase I Clinical Trial with Ex Vivo Expanded Recipient Regulatory T cells in Living Donor Kidney Transplants” was recently published in SCIENTIFIC REPORTS and is provided as an attachment.
The Phase II clinical study design and statistical plan was approved by the Food and Drug Administration (FDA) and will initiate enrollment once financing is obtained.
The Company’s platform product, TregCel™, is capable of delivering expanded autologous T regulatory cells for various indications in solid organ transplant and autoimmune disease. TRACT Therapeutics will seek Orphan Drug Designation late in 2018 in the U.S. for solid organ transplantation and selected autoimmune diseases.
Plans to launch a Phase I Crohn’s Disease trial and a Phase I Autoimmune Hepatitis trial are ongoing and are expected to be approved for enrollment late in 2018.
Please reference the timeline below for detailed information regarding the current status of TRACT Therapeutics clinical trials: