Kiadis Pharma Receives Regulatory Approval from Health Canada for a Phase II Clinical Study with its Blood Cancer Treatment ATIR™

Amsterdam, The Netherlands, February 26, 2013 – Kiadis Pharma B.V., a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing treat­ments for blood can­cers, announced today it has received the No Objection Letter from Health Canada for its new clin­i­cal study with ATIR™. This study will be a Phase II inter­na­tion­al mul­ti-cen­ter study with clin­i­cal sites in Canada and Belgium. Up to 23 patients will be treat­ed in this study to cor­rob­o­rate and extend the safe­ty and effi­ca­cy results from Kiadis Pharma‘s pre­vi­ous Phase I/II clin­i­cal study with ATIR™.
The coor­di­nat­ing inves­ti­ga­tor for the study will be Denis-Claude Roy, MD, pro­fes­sor of med­i­cine at the University of Montreal. ATIR™ is a cell-based prod­uct designed to enable stem cell trans­plan­ta­tions from mis­matched (hap­loiden­ti­cal) fam­i­ly donors.
“We are very hap­py that after hav­ing received approval from the Research Ethics Board of the Maisonneuve-Rosemont Hospital, we have now also gained approval from Health Canada and can com­mence with our new clin­i­cal study in Canada”, com­ment­ed Manfred Ruediger, PhD, Chief Executive Officer of Kiadis Pharma. “This study will be an impor­tant step for­ward in devel­op­ing ATIR™ as an inno­v­a­tive ther­a­peu­tic option for severe­ly dis­eased blood can­cer patients. Today, many of these patients die because a matched stem cell donor can­not be found.”
Dr. Denis-Claude Roy added: “We are excit­ed that we can start this Phase II clin­i­cal study with ATIR™ in which we will treat blood can­cer patients for whom a matched donor is not avail­able for a stan­dard trans­plan­ta­tion pro­ce­dure. This study pro­vides these patients with the oppor­tu­ni­ty to receive a stem cell trans­plan­ta­tion from a fam­i­ly mem­ber with ATIR™ added as an adjunc­tive treat­ment to pro­vide rapid and potent immune pro­tec­tion and min­i­mize post-trans­plant risks.”

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