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.
Manfred Ruediger, PhD, Chief Executive Officer of Kiadis Pharma, commented: "We are pleased to be working with GRCBDS who are now successfully manufacturing the clinical material for our ongoing Phase II trial with ATIR™ in Europe. GRCBDS' experience in the field of cell therapy, combined with their know-how and expertise in Hemato-Oncology, are key reasons to collaborate with them on ATIR™'s promising clinical development program."
Prof. Erhard Seifried, Medical Director of GRCBDS, stated: "We are delighted to enter into this agreement with Kiadis Pharma, an innovator for blood cancer treatment, and to be part of this exciting and highly ethical development of enabling mismatched stem cell transplantations for patients suffering from blood cancer and being in desperate need of a transplant."
Prof. Halvard Bönig, Head of the Department of Cellular Therapeutics / Cell Processing (GMP) of GRCBDS, added: "Given our extensive experience with technology transfer, process qualification and GMP manufacturing, we feel GRCBDS will be an asset to Kiadis Pharma as it further develops ATIR™."
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