Kiadis Pharma B.V., a clinical stage biopharmaceutical company developing treatments for blood cancers, announced today that a Services Agreement has been signed with the German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen (GRCBDS) whereby GRCBDS will provide pharmaceutical development and GMP manufacturing services for Kiadis Pharma's ongoing Phase II clinical study with ATIR™.
The transfer of the manufacturing process for ATIR™ has already successfully been completed by GRCBDS at their facility in Frankfurt am Main, Germany and a first batch of Phase II clinical trial material for the European study has now been successfully manufactured.
GRCBDS is one of the largest blood donor services in Europe and has vast expertise and experience in GMP manufacturing blood-derived products for use in daily clinical practice. Furthermore, GRCBDS has experience in manufacturing other cell-based investigational medicinal products which are tested in European clinical studies.
Kiadis Pharma, which has its own GMP manufacturing license, initiated a Phase II international multi-center study with ATIR™ with up to 23 leukemia patients to corroborate and extend the safety and efficacy results of the previous successful Phase I/II study. Enrollment of patients commenced in Canada in April 2013 and in Europe in August 2013. Topline results are expected in H1 2014.