Kiadis Pharma Presents Positive Data from a Pre-spec­i­fied Interim Analysis of the Phase II Clinical Program with its Lead Product ATIR™

~ Data con­firms the poten­tial of ATIR™ in par­tial­ly matched hematopoi­et­ic stem cell trans­plants ~
Amsterdam, The Netherlands, December 9, 2014 – Kiadis Pharma B.V. (“Kiadis Pharma”), a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny devel­op­ing T-cell immunother­a­py treat­ments for blood can­cers, today announces pos­i­tive inter­im data from the ongo­ing Phase II clin­i­cal study with its lead prod­uct ATIR™. The data were pre­sent­ed by Dr. Denis-Claude Roy, Professor of Medicine at the University of Montreal and Chair of the study, at the American Society of Hematology (ASH) Annual Meeting in San Francisco (Abstract 314).
ATIR™ is a cell-based prod­uct designed to enable stem cell trans­plan­ta­tions from par­tial­ly­matched (hap­loiden­ti­cal) fam­i­ly donors for blood can­cer patients who do not have a stan­dard of care stem cell donor avail­able. The Phase II study is an inter­na­tion­al mul­ti-cen­ter study in which 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 ATIR™ as part of the trans­plant reg­i­men. The pri­ma­ry end­point of the study is the rate of Transplant Related Mortality (TRM) at 6 months after hematopoi­et­ic stem cell trans­plan­ta­tion (HSCT). Data from the pre-spec­i­fied inter­im analy­sis of the first 10 patients showed only 2 cas­es of TRM at 6 months post-HSCT and both TRM cas­es result­ed from a viral infec­tion. Overall, 6 out of the 10 patients were com­plete­ly free from severe infec­tions (grade 3-5) after ATIR™ admin­is­tra­tion and up to 6 months after the trans­plant.
These data con­firm the safe­ty and effi­ca­cy of ATIR™ admin­is­tra­tion with no grade III-IV (lifethreat­en­ing) acute Graft ver­sus Host Disease (GvHD) occur­ring, despite the fact that no pro­phy­lac­tic immune sup­pres­sants were used. Only a lim­it­ed num­ber of grade I-II GvHD events were report­ed, all of which were treat­ed suc­cess­ful­ly. Furthermore, no relaps­es were report­ed in any of the first 10 patients, with 4 out of the 10 patients in fol­low-up for more than one year at the time of the inter­im analy­sis.
These data are in line with the data pre­vi­ous­ly report­ed from Kiadis Pharma’s Phase I/II study with 19 patients. The cur­rent study is pro­gress­ing well with fur­ther enroll­ment of patients in Canada (Hôpital Maisonneuve-Rosemont (Montreal), Juravinski Hospital and Cancer Centre (Hamilton) and Princess Margaret Cancer Centre (Toronto)), Belgium (University Hospitals Leuven, AZ Sint Jan (Bruges) and Institut Jules Bordet (Brussels)) and Germany (University Hospital of Würzburg).
Dr. Denis-Claude Roy, Professor of Medicine at the University of Montreal and Chair of the study, said: “ATIR™ has demon­strat­ed its poten­tial to pro­vide potent immune pro­tec­tion against lethal infec­tious com­pli­ca­tions and resid­ual tumor cells with­out caus­ing clin­i­cal­ly crit­i­cal GvHD as an add-on for blood can­cer patients who have received a stem cell trans­plan­ta­tion from an only par­tial­ly matched fam­i­ly mem­ber. This offers hope to patients who cur­rent­ly can­not be treat­ed with a trans­plan­ta­tion because of the lim­it­ed avail­abil­i­ty of suit­able matched donors.”
Manfred Ruediger, PhD, Chief Executive Officer of Kiadis Pharma, com­ment­ed: “The results from this inter­im analy­sis are very encour­ag­ing and show the sig­nif­i­cant poten­tial of ATIR™ as a treat­ment option to enable stem cell trans­plan­ta­tions from par­tial­ly matched fam­i­ly donors for blood can­cer patients who do not have a stan­dard of care stem cell donor avail­able. We also believe ATIR™ has poten­tial as a cura­tive treat­ment for blood can­cer patients who have relapsed already once or more times on oth­er treat­ments and who would cur­rent­ly not receive a stem cell trans­plan­ta­tion because of lim­it­ed donor avail­abil­i­ty. These data, pre­sent­ed at ASH by Dr. Denis-Claude Roy, were very well received and we look for­ward to pro­vid­ing fur­ther updates on the ongo­ing study in due course.”

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