Posted by Michael Wonder on 26 Jun 2016
MolMed receives positive CHMP opinion recommending conditional marketing authorisation for Zalmoxis, the first immunogene therapy to treat high-risk haematological malignancies in patients receiving haplo-identical haematopoietic stem cell transplantation
24 June 2016 - The CHMP of the EMA, in conjunction with the Committee for Advanced Therapies, has issued a positive opinion recommending conditional marketing authorisation for Zalmoxis, the first immunogene therapy as patient-specific adjunctive treatment in haplo-identical haematopoietic stem-cell transplantation for adult patients with high-risk haematological malignancies.
Zalmoxis innovative therapy is based on genetically engineering donor immune system T cells to carry an inducible “suicide gene”. Administered to patients following haematopoietic stem-cell transplantation (HSCT) from partially compatible donors (haplo-identical HSCT), these cells foster an anti-leukaemia effect by eliminating post-transplant immunosuppression prophylaxis and inducing a rapid immune reconstitution. The suicide gene allows to readily control graft versus host disease (GvHD), the most significant and serious adverse event in haplo-identical transplantation, caused by the genetic disparity between patient and donor. Zalmoxis significantly increases long-term survival, regardless of disease status at transplant, thus making HSCT from partially compatible donors safer and more effective.
For more details, go to: http://www.molmed.com/sites/default/files/uploads/press-releases/2886/2886_1466767095.pdf
