Date: 2013-10-07
Type of information: Services contract
Compound: pharmaceutical development and GMP manufacturing services for ATIR™
Company: Kiadis Pharma (The Netherlands) German Red Cross Blood Donor Service Baden-Wuerttemberg-Hessen (GRCBDS) (Germany)
Therapeutic area: Technology - Services
Type agreement: development
services
Action mechanism:
Disease:
Details: * On October 7, 2013, Kiadis Pharma, a biopharmaceutical company developing treatments for blood cancers, has announced 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.
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.
An international multi-center Phase II study including patients with acute myeloid leukemia, acute lymphoblastic leukemia and myelodysplastic syndrome, to confirm and extend the data from the Phase I/II study, is now ongoing with topline results of the first phase expected in H1 2014.
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