Kiadis Pharma announces enrol­ment of first patient in its repeat-dos­ing Phase II clin­i­cal tri­al with ATIR101™

Amsterdam, The Netherlands, October 20, 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 the first patient has been enrolled into its repeat-dos­ing Phase II clin­i­cal tri­al, CR-AIR-008, with its lead prod­uct ATIR101™. The patient was enrolled in Hamilton, Canada with­in a month of receiv­ing reg­u­la­to­ry approval for the study from the Canadian author­i­ties.
In this new tri­al the safe­ty and effi­ca­cy of admin­is­trat­ing a sec­ond dose of ATIR101™ after the ini­tial stem cell trans­plan­ta­tion to patients with blood can­cer, to fur­ther improve the out­come of their stem cell trans­plan­ta­tion, will be stud­ied (NCT02500550 / EudraCT 2015-002821-20).
The study has now been approved by author­i­ties in Canada, Belgium and the United Kingdom, with approval pend­ing in Germany. The Company also plans to expand the study to the USA pend­ing reg­u­la­to­ry approval. A total of 15 leukaemia patients with acute myeloid leukaemia (AML), acute lym­phoblas­tic leukaemia (ALL) or myelodys­plas­tic syn­drome (MDS) will be enrolled.
Dr. Irwin Walker, Professor of Medicine at the McMaster University in Hamilton and Principal Investigator of the study, com­ment­ed: “We are very excit­ed about par­tic­i­pat­ing in this repeat dos­ing study with ATIR101™. Already, a sin­gle-dose admin­is­tered in the pre­vi­ous Phase II study had shown very promis­ing data. We are there­fore keen on con­tribut­ing to this next devel­op­ment step.”
Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, com­ment­ed: “We are very pleased about the dynam­ics in our ATIR101™ devel­op­ment and the progress we have made on-track since our recent IPO. We believe that this new study will add addi­tion­al impor­tant data for the out­line of a best study design for a Phase III tri­al that we antic­i­pate to start in the sec­ond half of next year. We believe that ATIR101™ has the poten­tial to add sig­nif­i­cant val­ue in reduc­ing infec­tions and relapse rates and to avoid severe acute GVHD that is seen with oth­er cur­rent approach­es.”

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