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Kiadis Pharma Appoints Jeroen Rovers as its Chief Medical Officer
Date:9/3/2014

urative option for many patients but a matching donor is available for only half of the patients in need. ATIR™ thus has the potential to address this unmet need and to make a HSCT available for all patients worldwide.

Those T-cells in a haploidentical graft which would cause Graft-versus-Host-Disease (GvHD) are selectively eliminated using proprietary technology to produce ATIR™. ATIR™ is administered as an adjunctive treatment after a T-cell depleted haploidentical HSCT facilitating early immune reconstitution without causing life-threatening (acute) GvHD.

ATIR™ dovetails current approaches that render a patient eligible for a stem cell transplantation. Usually, only patients in remission are considered eligible for such a transplantation and so approaches that put refractory patients into remission, such as Chimeric Antigen Receptor (CAR) T-cell therapies, will increase the need for donors and potentially, therefore, the need for ATIR™.

In a Phase I/II study in which high-risk leukemia patients with very poor prognosis were treated with escalating doses of ATIR™ after a haploidentical HSCT, long-term safety, efficacy and proof of concept were confirmed in terms of absence of Grade III/IV (life-threatening) acute GvHD, reduced rates of infection, reduced Transplant Related Mortality and high Overall Survival. Positive follow-up results from this study demonstrating 67% survival after five years and no Transplant Related Mortality in the nine patients who received an efficacious dose of ATIR™ were recently reported.

An international multi-center Phase II study including patients with acute myeloid leukemia, acute lymphoblastic leukemia and myelodysplastic syndrome, to corroborate and extend the safety and efficacy results from the Phase I/II study, is now ongoing with topline data expected in the second half of 2014.  

ATIR™ has been granted Orphan Drug Designation both in
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