Kiadis Pharma Completes Five-year Follow-up of its Phase I/II Clinical Study with Blood Cancer Product ATIR™ and Study Meets Primary Objective ~ 67% sur­vival demon­strat­ed after 5 years and no trans­plant relat­ed mor­tal­i­ties ~

Amsterdam, The Netherlands, September 11, 2013 – Kiadis Pharma B.V., a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing treat­ments for blood can­cers, announced today that the five-year fol­low-up of patients with high-risk malig­nan­cies from its Phase I/II clin­i­cal study con­firms long-term safe­ty and effi­ca­cy of ATIR™ over a broad dose range. ATIR™ is a cell-based prod­uct designed to enable stem cell trans­plan­ta­tions from par­tial­ly mis­matched (hap­loiden­ti­cal) fam­i­ly donors for patients who do not have a stan­dard of care stem cell donor avail­able. The results demon­strate proof of con­cept and show that ATIR™ infu­sion after a T-cell deplet­ed hap­loiden­ti­cal hematopoi­et­ic stem cell trans­plan­ta­tion (HSCT) pro­vides immune pro­tec­tion short­ly after the trans­plan­ta­tion and improves long-term out­come in high-risk patients with very poor prog­no­sis.
Not only does the study con­firm that ATIR™ pro­vides an effec­tive treat­ment for patients for whom a stan­dard of care stem cell donor is not avail­able, the long term sur­vival even seems to com­pare favor­ably to patients who do have a stan­dard of care matched unre­lat­ed donor avail­able. The over­all sur­vival of patients with high-risk malig­nan­cies in the Phase I/II study who received an effi­ca­cious dose of ATIR™ was 78% and 67% after one and five years, respec­tive­ly. Data from the Center for International Blood & Marrow Transplant Research (CIMBTR) show that the one (and five) year sur­vival of patients with acute myeloid leukemia (AML) who do have a stan­dard of care matched unre­lat­ed donor avail­able, varies from 65% (and 35%) in low-risk patients to 45% (and 20%) in high-risk patients, respec­tive­ly.
In this Phase I/II study, 19 high-risk leukemia patients were treat­ed with esca­lat­ing dos­es of ATIR™ after a hap­loiden­ti­cal HSCT. The five-year fol­low-up data show no trans­plant relat­ed mor­tal­i­ty in the nine patients who received an effi­ca­cious dose of ATIR™. In addi­tion, no Grade III-IV (life-threat­en­ing) acute Graft ver­sus Host Disease (GvHD) was observed at any dose, which again com­pares favor­ably to stan­dard of care matched unre­lat­ed donor trans­plan­ta­tions, where (accord­ing to data from the CIBMTR) inci­dence of life-threat­en­ing GvHD is 30%. The strong five-year sur­vival data also sug­gest that immune cells respon­si­ble for the Graft ver­sus Leukemia effect are retained in ATIR™. The results of the study allowed select­ing the opti­mal ATIR™ dose for fur­ther devel­op­ment. Data from this five-year study will be pub­lished in due course in a peer-reviewed med­ical jour­nal.
An inter­na­tion­al mul­ti-cen­ter Phase II study includ­ing patients with AML, acute lym­phoblas­tic leukemia (ALL) and myelodys­plas­tic syn­drome (MDS), to con­firm and extend the data from the Phase I/II study, is now ongo­ing with topline results of the first phase expect­ed in H1 2014.
Manfred Ruediger, PhD, Chief Executive Officer of Kiadis Pharma, com­ment­ed: “The results from this study, which spans five years, show that ATIR™ might change the way in which patients with hema­to­log­i­cal malig­nan­cies will be treat­ed. These data show that ATIR™ not only pre­vents sig­nif­i­cant infec­tions with­out elic­it­ing life-threat­en­ing GvHD, but also strong­ly improves sur­vival rates in patients with high-risk malig­nan­cies and very poor prog­no­sis. Our cur­rent­ly ongo­ing inter­na­tion­al Phase II clin­i­cal study is designed to con­firm and extend these data to expe­dite mov­ing ATIR™ towards reg­u­la­to­ry approval.”
Dr. Denis-Claude Roy, Professor of Medicine at the University of Montreal and prin­ci­pal inves­ti­ga­tor for the study, added: “We are very excit­ed about the long-term effects of ATIR™. In demon­strat­ing very strong effi­ca­cy in min­i­miz­ing post-trans­plan­ta­tion risks and improv­ing over­all sur­vival, these long-term data rep­re­sent a poten­tial major advance­ment in pro­vid­ing patients for whom a suit­able matched donor is not avail­able, with the oppor­tu­ni­ty to receive an HSCT from a mis­matched fam­i­ly mem­ber with ATIR™ added as an adjunc­tive treat­ment.”

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