MolMed seeking conditional EU approval of TK

MolMed S.p.A. (Milan:MLM) 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. ...