Kiadis Pharma Provides Positive Update on its Phase II Clinical Program with Blood Cancer Treatment ATIR™ – 6 month fol­low-up data expect­ed in H1 2014 –

Amsterdam, The Netherlands, November 18, 2013 – Kiadis Pharma B.V., a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing treat­ments for blood can­cers, today announces the suc­cess­ful Phase II enroll­ment of approx­i­mate­ly ten patients of whom the major­i­ty have already been trans­plant­ed and received ATIR™. Kiadis Pharma’s lead pro­gram, ATIR™, is a cell-based prod­uct designed to enable stem cell trans­plan­ta­tions from par­tial­ly mis­matched (hap­loiden­ti­cal) fam­i­ly donors for blood can­cer patients who do not have a stan­dard of care stem cell donor avail­able. Topline data from the tri­al (CR-AIR-007) is expect­ed in the first half of 2014.
The CR-AIR-007 Phase II clin­i­cal study is an inter­na­tion­al mul­ti-cen­ter study under­tak­en to cor­rob­o­rate and extend the safe­ty and effi­ca­cy results from the pre­vi­ous suc­cess­ful Phase I/II dose-esca­la­tion study with ATIR™. A total of 23 leukemia patients, includ­ing patients with acute myeloid leukemia (AML), acute lym­phoblas­tic leukemia (ALL) and myelodys­plas­tic syn­drome (MDS) will be enrolled and treat­ed with the opti­mal dose iden­ti­fied in the Phase I/II study. The pri­ma­ry end­point of the tri­al is the rate of trans­plant relat­ed mor­tal­i­ty six months post a hap­loiden­ti­cal stem cell trans­plant. Secondary end­points include over­all sur­vival (OS) at one year after trans­plant as well as relapse rat­ed mor­tal­i­ty, non-relapse relat­ed mor­tal­i­ty, inci­dence of acute and chron­ic Graft ver­sus Host Disease (GvHD) and rate of severe infec­tions. Enrollment of patients com­menced in Canada and Belgium in April and August 2013, respec­tive­ly, with the Maisonneuve-Rosemont Hospital in Montreal and Hamilton Health Sciences par­tic­i­pat­ing in Canada and the University Hospitals Leuven, the Institute Jules Bordet in Brussels and the Sint-Jan Academic Hospital in Bruges par­tic­i­pat­ing in Belgium.
Manfred Ruediger, PhD, Chief Executive Officer of Kiadis Pharma, com­ment­ed: “We are delight­ed that the enroll­ment into CR-AIR-007 is pro­gress­ing accord­ing to plan. This demon­strates the demand for ATIR™ and its sig­nif­i­cant poten­tial as a life­sav­ing blood can­cer treat­ment. All patients cur­rent­ly enrolled in the study are alive and doing well and none of them have yet to expe­ri­ence any acute GvHD or seri­ous infec­tions. The major­i­ty of patients have been on the study for between two to sev­en months. We look for­ward to report­ing the topline Phase II data in the first half of 2014.” He con­tin­ues: “Having suc­cess­ful­ly trans­ferred our man­u­fac­tur­ing process for ATIR™ to our European CMO in Frankfurt am Main, Germany, we now have two man­u­fac­tur­ing facil­i­ties using our robust process, one for our European sites and one in Montreal for our Canadian sites.”

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