ARTICLE | Clinical News

TK regulatory update

March 10, 2014 7:00 AM UTC

MolMed submitted an MAA to EMA seeking conditional approval of TK as adjunctive treatment for high-risk leukemia patients undergoing hematopoietic stem cell transplantation (HSCT). MolMed said TK - which comprises donor lymphocytes engineered to express the human herpes simplex thymidine kinase suicide gene - allows patients to undergo HSCT from a mismatched donor without post-transplant immunosuppression. The company is seeking conditional approval based on data from the Phase I/II TK007 trial, which showed TK reduced transplant-related mortality and increased overall survival in patients with a mismatched HSCT donor, as well as initial data from the ongoing Phase III TK008 trial of TK (see BioCentury, April 13, 2009). ...