First Patient Enrolled in Phase 3 Trial for ATIR101™ in Adult Patients with Blood Cancer
Monday, December 04, 2017
Kiadis Pharma N.V., a clinical stage biopharmaceutical company developing innovative cell-therapy products to make bone marrow transplantations safer and more effective for patients, today announces that the first patient has been enrolled in the HATCY Phase 3 clinical trial for ATIR101™.
The multinational trial will evaluate the safety and efficacy of ATIR101™ as an adjunctive treatment to blood stem cell transplantation from a half-matched (haploidentical) family donor compared to post-transplant cyclophosphamide (PTCy or ‘Baltimore’ protocol) in adult patients with blood cancer.
Andrew Sandler, Chief Medical Officer of Kiadis Pharma, commented: “We are pleased that the first patient has been enrolled in the Phase 3 trial for our innovative cell-therapy product ATIR101™. Although the ‘Baltimore’ protocol has made haploidentical transplants feasible, a huge unmet need remains due to high relapse rates and occurrence of graft versus host disease.”
Arthur Lahr, Chief Executive Officer of Kiadis Pharma, commented: “The start of this large multinational Phase 3 clinical trial marks another important step in the development of Kiadis. We aim to submit the results from this Phase 3 trial to the US FDA, while we continue to progress the European filing submitted earlier this year to EMA based on our Phase 2 data.”
