Kiadis Pharma B.V., a clinical stage biopharmaceutical company developing treatments for blood cancers, today announces the successful Phase II enrollment of approximately ten patients of whom the majority have already been transplanted and received ATIR™. Kiadis Pharma's lead program, ATIR™, is a cell-based product designed to enable stem cell transplantations from partially mismatched (haploidentical) family donors for blood cancer patients who do not have a standard of care stem cell donor available. Topline data from the trial (CR-AIR-007) is expected in the first half of 2014.
The CR-AIR-007 Phase II clinical study is an international multi-center study undertaken to corroborate and extend the safety and efficacy results from the previous successful Phase I/II dose-escalation study with ATIR™. 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 the optimal dose identified in the Phase I/II study. The primary endpoint of the trial is the rate of transplant related mortality six months post a haploidentical stem cell transplant. Secondary endpoints include overall survival (OS) at one year after transplant as well as relapse rated mortality, non-relapse related mortality, incidence of acute and chronic Graft versus Host Disease (GvHD) and rate of severe infections. Enrollment of patients commenced in Canada and Belgium in April and August 2013, respectively, with the Maisonneuve-Rosemont Hospital in Montreal and Hamilton Health Sciences participating in Canada and the University Hospitals Leuven, the Institute Jules Bordet in Brussels and the Sint-Jan Academic Hospital in Bruges participating in Belgium.
Manfred Ruediger, PhD, Chief Executive Officer of Kiadis Pharma, commented: "We are delighted that the enrollment into CR-AIR-007 is progressing according to plan. This demonstrates the demand for ATIR™ and its significant potential as a lifesaving blood cancer treatment. All patients currently enrolled in the study are alive and doing well and none of them have yet to experience any acute GvHD or serious infections. The majority of patients have been on the study for between two to seven months. We look forward to reporting the topline Phase II data in the first half of 2014." He continues: "Having successfully transferred our manufacturing process for ATIR™ to our European CMO in Frankfurt am Main, Germany, we now have two manufacturing facilities using our robust process, one for our European sites and one in Montreal for our Canadian sites."
Scientists discover key genetic factors behind testicular cancer