TK is an innovative cell therapy that aims to boost the survival of leukaemia patients undergoing stem cell transplantation with partially incompatible family donors, known as haplo-identical Haematopoietic Stem Cell Transplantation (haplo-HSCT). It involves the use of genetically engineered donor T lymphocytes in association with haplo-HSCT, in order to overcome serious complications arising from the transplant, while fully maintaining its immune-protective and anti-leukaemia effects. The most important complication of haplo-transplants is Graft versus Host Disease (GvHD), a systemic immune reaction mediated by donor T lymphocytes against the recipient's tissues. With MolMed's TK therapy, genetically modified donor T cells are made sensitive to the antiviral drug ganciclovir, and can be selectively eliminated through the administration of the drug if GvHD occurs.
A phase I/II multicentric study in the EU - TK007 - has been successfully completed (TK007 trial protocol)
ASCO 2010 - Poster on long-term follow-up data of trial TK007 (ASCO abstract #6534)
A Phase III study has started in Italy in 2008, planned to become an international trial within 2010.
TK was granted Orphan Drug designation both in the EU (2003) and in the US (2005).
MolMed’s strategic partner Takara Bio Inc. (Japan) is developing TK for the Asian markets.
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