European Commission grants a conditional approval for Zalmoxis as a patient-specific adjunctive treatment in haplo-identical haematopoietic stem-cell transplantation. - MolMed S.p.A.

MolMed S.p.A. announced that the European Commission has granted a Conditional Marketing Authorisation (CMA) for Zalmoxis, the first immunogene therapy, as patient-specific adjunctive treatment in haplo-identical haematopoietic stem-cell transplantation (HSCT) for adult patients with high-risk haematological malignancies.

It is estimated that in the EU approximately 1,3001 high-risk haematological malignancies patients per year undergo haplo-identical HSCT, growing 30% annually. In addition, almost 11,0001 patients with high-risk haematological malignancies are candidate for allogeneic transplant and lack a fully compatible donor, for whom Zalmoxis might represent a viable therapeutic solution. Zalmoxis innovative therapy is based on genetically engineering donor immune system T cells to carry an inducible �suicide gene�. Administered to patients following HSCT from partially compatible donors (haploidentical HSCT), these cells foster an anti-leukemia effect by eliminating post-transplant immunosuppression prophylaxis and inducing a rapid immune reconstitution.