TRACT Therapeutics has successfully completed the Phase I Kidney 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 Transplantswas published in SCIENTIFIC REPORTS in 2018 and is provided as an attachment.

The Phase II Kidney clinical  trial (3 arms, 120 subjects) study design and statistical plan was approved by the Food and Drug Administration (FDA) and will initiate enrollment in October 2019.

Plans to launch an FDA-approved Phase I Crohn’s Disease trial in a single site is also scheduled for October 2019.

The Company’s platform product, TregCel™, is capable of delivering expanded autologous T regulatory cells for a variety of autoimmune indications. A Phase I Autoimmune Hepatitis clinical trial was funded by a grant award and is in the process of obtaining FDA approval to initiate enrollment.

Please reference the timeline below for detailed information regarding the current status of TRACT Therapeutics clinical trials:

 

SCIENTIFIC REPORTS, A Phase I Clinical Trial with Ex Vivo Expanded Recipient Regulatory T Cells in Living Donor Kidney Transplants” April 2018.