Talaris Therapeutics Announces Launch of Phase 2 Clinical Trial of FCR001 in Induction of Delayed Tolerance | DNA RNA and cells
Talaris Therapeutics Announces Phase 2 Clinical Trial of FCR001 in Induction of Delayed Tolerance
Category: DNA RNA and cells
Posted on Friday, October 29, 2021 6:01 PM
The FREEDOM-2 trial will assess the potential of the company’s experimental allogeneic cell therapy, FCR001, to induce long-lasting immune tolerance in patients who have previously received a kidney from a living donor
BOSTON, MA, USA I October 29, 2021 ITalaris Therapeutics, Inc., (Nasdaq: TALS), a clinically advanced cell therapy company that develops therapies that have the potential to transform the standard of care into solid organ transplants, some serious autoimmune diseases, and some serious blood, immune and metabolic disorders that are not malins, today announced the launch of the Company’s FREEDOM-2 Phase 2 study. Northwestern University is the first FREEDOM-2 clinical site to be activated and has now started to search for eligible patients. Additional sites are expected to be activated in 2022. This trial will explore the safety and efficacy of the company’s experimental allogeneic cell therapy, FCR001, to induce immune tolerance to a transplanted kidney in patients who have received the transplant. a donor living for up to a year. before administration of FCR001.
“This trial exploring the efficacy of FCR001 in delayed tolerance is an important step towards potentially offering an alternative to long-term immunosuppression as a standard of care for organ transplant recipients. today, “said Nancy Krieger, MD, medical director of Talaris. . “We believe that this innovative approach could allow us to broaden the possibility of applying this new therapy to larger patient populations by expanding the options for previously transplanted patients whose donor is still available. “
FREEDOM-2 (NCT # NCT01649388) is an open-label, single-arm, multicenter study exploring the preliminary efficacy and safety of FCR001, the company’s experimental allogeneic cell therapy, in living donor kidney transplant recipients 3 to 12 months after transplantation. The study consists of a one-time treatment given with non-myeloablative conditioning, after which the patients are followed for five years, with a primary analysis performed at 24 months.
“As a physician, I believe the ability to induce immune tolerance to a previously transplanted organ would be transformative,” said Joseph R. Leventhal, MD, Ph.D., Fowler McCormick professor of surgery at Northwestern University Feinberg School of Medicine, and the principal investigator of the FREEDOM-2 trial. “I look forward to leading this important study and the insights it will bring to improve patient care. “
FCR001 is an experimental allogeneic cell therapy developed by Talaris Therapeutics to induce or restore immune tolerance in patients. The FCR001 builds on more than 30 years of research by company founder Dr Suzanne Ildstad into ways in which long-lasting immune tolerance can be induced in a patient who receives a transplanted organ or can be restored in patients with certain immune or blood disorders. troubles. FCR001 has received both Orphan Drug Designation and Advanced Regenerative Medicine (RMAT) designation from the United States Food and Drug Administration. A phase 3 trial of FCR001 in living kidney transplant donors, FREEDOM-1, is currently enrolling patients; more information can be found at: http://freedom1study.com/
About Talaris Therapeutics
Talaris Therapeutics, Inc. is an advanced clinical biopharmaceutical company developing experimental, unique allogeneic cell therapies with the potential to transform the standard of care in solid organ transplants, some serious autoimmune diseases, and some non-malignant blood. severe, immune and metabolic disorders. Talaris has offices in Boston, MA, and its cell processing plant in Louisville, KY.
THE SOURCE: Talaris Therapeutics