FDA approves Tract Therapeutics to begin Phase ll trial of Treg therapy

2nd May 2016 (Last Updated May 2nd, 2016 18:30)

The US Food and Drug Administration (FDA) has granted approval for Tract Therapeutics to conduct a Phase ll clinical trial examining the efficacy and safety of T-cell (Treg) therapy for kidney transplant recipients.

The US Food and Drug Administration (FDA) has granted approval for Tract Therapeutics to conduct a Phase ll clinical trial examining the efficacy and safety of T-cell (Treg) therapy for kidney transplant recipients.

The Phase ll study will enrol 120 subjects and evaluate the efficacy and safety of a single Treg infusion in kidney transplant recipients, with a plan to initiate enrolment in a few months.

Northwestern University Feinberg School of Medicine kidney and pancreas transplantation director Joseph Leventhal said: "The limitations of drug-based immunosuppression have significantly increased interest in the use of regulatory T-cells to restore balance to the immune system and avoid transplant rejection."

Currently, Tract Therapeutics is developing the Treg therapy to restore immune balance in organ transplantation and autoimmune disease.

"The limitations of drug-based immunosuppression have significantly increased interest in the use of regulatory T-cells to restore balance to the immune system and avoid transplant rejection."

The company's proprietary platform technology, using autologous polyclonally expanded regulatory T-cells was developed at Northwestern University, US.

According to Tract, the therapeutic approach, utilising a patient's own cells, expanded in the laboratory and infused back to the patient after an organ transplant, shows positivity in restoring immune balance so the body will accept the foreign organ instead of rejecting it.

Existing standard of care practices for transplant patients to prevent rejection requires the lifetime use of toxic medications that weaken the immune system, causing life-threatening effects and eventual rejection of the organ in around 50% of the patients receiving a transplant.

Recently, a study of National Institute of Health study in the US revealed that organ recipients have a high risk of developing 32 different types of cancer.

Tract's new approach seeks to change the standard treatment for transplant recipients by reducing or eliminating the lifelong use of immunosuppressive drug therapy.

Tract Therapeutics president and CEO Gretchen Johnson said: "We are pleased to continue on our path toward approval and commercialisation of this novel Treg therapy, with the goal of greatly enhancing the lives of transplant patients around the world."