Tract Therapeutics completes Phase I safety trial using patient’s immune cells to prevent organ rejection

The study, approved by the Food and Drug Administration (FDA), was conducted at Northwestern Memorial Hospital.

The therapeutic approach utilizing a patient’s own cells expanded in the laboratory and reinfusing them after the organ transplant shows great promise in restoring immune balance so the body will accept the foreign organ instead of rejecting it.

Current standard of care practices for transplant patients includes the required lifetime use of toxic medications which weaken the immune system causing life-threatening effects and eventual rejection of the organ. TRACT’s approach aims to reduce or eliminate the lifelong use of immunosuppressive drug therapy.

Approximately 30,000 patients receive a solid organ transplant in the United States each year; 18,000 of which are kidneys.

Joseph R. Leventhal, MD, PhD, Director of Kidney and Pancreas Transplantation at Northwestern University Feinberg School of Medicine stated "The opportunity to provide an alternative therapy that will actually regulate the patient’s immune system instead of suppressing it with drugs, presents a tremendous opportunity to resolve a clinical need that has not been met with for patients with organ transplants and autoimmune diseases."

Gretchen S. Johnson, President and CEO of TRACT Therapeutics, commented, "Today’s announcement signifies a major milestone for both the early success of this clinical approach and the potential to improve the lives of patients with transplants and those suffering from autoimmune disorders."