TRACT Therapeutics, Inc. Presents Follow-Up Phase I Clinical Data in Kidney Transplant Recipients at the American Transplant Congress 2016

Friday, July 29, 2016

CHICAGO--(BUSINESS WIRE)-- An abstract entitled, “Results of a Phase I Trial of Treg Adoptive Cell Transfer (TRACT) In De Novo Living Donor Kidney Transplant Recipients” was received with great enthusiasm by transplant surgeons and the scientific community at the recent American Transplant Congress Meeting held in Boston, Massachusetts. TRACT Therapeutics, Inc., a biotechnology company, developing personalized regulatory T-cell (Treg) therapy, is the first company to complete a clinical study utilizing regulatory T-cell therapy to treat kidney transplant patients in order to avoid rejection of the donated organ. The therapeutic approach, utilizing a patient’s own cells, expanded in the laboratory and infused back to the patient after an organ transplant, shows promise in restoring immune balance so the body will accept the foreign organ instead of rejecting it. TRACT’s innovative approach aims to change the standard treatment for transplant recipients by reducing or eliminating the lifelong use of immunosuppressive drug therapy.

TRACT Therapeutics continues to advance its clinical programs and is preparing to initiate FDA-approved Phase II in kidney transplant within a few months. Phase I trials in both liver transplant and inflammatory bowel disease are in preparation for next year.

Anton Skaro, MD, PhD, Principal Investigator and Associate Professor in Surgery at Northwestern University Feinberg School of Medicine, presented the results of the Phase I Trial and commented, “Almost 50% of transplanted organs eventually fail due to rejection or complications from the required use of immunosuppressive drugs. Therefore, we are very encouraged by the early success of this clinical approach to induce immune tolerance in kidney transplant patients and look forward to its continued progress to the clinic.”

“The larger population of deceased donor organ recipients may also benefit from this therapeutic approach to collect a few million cells, multiplied ex vivo to a few billion cells and re-infused into the patient after transplantation,” stated Joseph Leventhal, MD, PhD, Director of Kidney and Pancreas Transplantation at Northwestern Feinberg School of Medicine.

About TRACT Therapeutics

TRACT Therapeutics, Inc. is a clinical-stage biotechnology company developing a novel therapeutic approach to restoring immune balance in organ transplantation and autoimmune disease. Its proprietary platform technology, using autologous polyclonally expanded regulatory T-cells was developed at Northwestern University by pioneer, Joseph R Leventhal, MD, PhD and his research colleagues. TRACT will file for Orphan Drug Designation for organ transplantation in 2016. For additional information, visit our website at: www.tracttherapeutics.com

This press release contains forward-looking statements that express the belief, potential anticipation or expectation, as well as other statements which are not historical fact, and statements related to clinical trials and their results, design, FDA product approvals or other marketing approvals, features, functionality and performance. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks include, among others: the regulatory approval process in the U.S. for biologics, market acceptance of new products, the ability to obtain and maintain patent or other proprietary intellectual property protection and the actual impact of those patents and rights, general market and economic factors, ability to effect transition from pilot-scale to large-scale commercial production of products, and availability of additional manufacturing capacity on acceptable terms.

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