Kiadis Pharma announces ini­ti­a­tion of a repeat-dos­ing Phase II clin­i­cal tri­al with ATIR101™

Amsterdam, The Netherlands, September 30, 2015 – Kiadis Pharma N.V. (“Kiadis Pharma” or “Company”) (Euronext Amsterdam and Brussels: KDS), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing inno­v­a­tive T-cell immunother­a­py treat­ments for blood can­cers and inher­it­ed blood dis­or­ders, today announces that it has obtained reg­u­la­to­ry approvals from the nation­al author­i­ties both in Canada and in Belgium to start a fur­ther Phase II clin­i­cal tri­al with its lead prod­uct ATIR101™. In this new tri­al the safe­ty and effi­ca­cy of using a sec­ond dose of ATIR101™ will be stud­ied (NCT02500550 / EudraCT 2015-002821-20).
ATIR101™ is a cell-based prod­uct designed to enable stem cell trans­plan­ta­tions from par­tial­ly matched (hap­loiden­ti­cal) fam­i­ly donors for blood can­cer patients who do not have a match­ing stem cell donor avail­able. Previously announced results obtained in pri­or and ongo­ing clin­i­cal stud­ies con­firm the safe­ty and effi­ca­cy of a sin­gle dose of ATIR101™ at 2×106 cells/kg, with no grade III-IV (life-threat­en­ing) acute Graft ver­sus Host Disease (GvHD) occur­ring, despite the fact that no pro­phy­lac­tic immune sup­pres­sants were used. Furthermore, only lim­it­ed severe infec­tions and relaps­es were report­ed in those stud­ies. The aim of the new Phase II tri­al is to test whether the admin­is­tra­tion of a sec­ond dose of ATIR101™ to a stem cell trans­plan­ta­tion at a lat­er point dur­ing treat­ment could fur­ther improve the trans­plan­ta­tion out­come.
The study will com­mence in Canada and Belgium and the Company plans to expand the study to the USA and oth­er European coun­tries pend­ing reg­u­la­to­ry approvals. A total of 15 leukaemia patients with acute myeloid leukaemia (AML), acute lym­phoblas­tic leukaemia (ALL) or myelodys­plas­tic syn­drome (MDS) will be enrolled. Kiadis Pharma expects to enroll the first patient into this study in Q4 2015.
Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, com­ment­ed: “We are excit­ed to ini­ti­ate anoth­er Phase II study with ATIR101™ on track with plans com­mu­ni­cat­ed at the time of our IPO. We have already demon­strat­ed the poten­tial of ATIR101™ to bet­ter pro­tect patients against trans­plant relat­ed mor­tal­i­ty and pro­vide anti-leukaemia reac­tiv­i­ty. The ful­ly func­tion­al T-cells in ATIR101™, col­lect­ed from a par­tial­ly mis­matched, hap­loiden­ti­cal fam­i­ly-donor, are able to fight infec­tions and resid­ual tumour cells with­out elic­it­ing acute grade III/IV GvHD in any patient as a result of Kiadis Pharma’s tech­nol­o­gy. In this next Phase II study we want to explore whether this effect can be even fur­ther max­i­mized by admin­is­ter­ing a sec­ond dose of ATIR101™.”

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