Kiadis Pharma Secures Manufacturing Services Agreement for its Phase II Clinical Program with Blood Cancer Treatment ATIR™ with the German Red Cross Blood Donor Service

Amsterdam, The Netherlands, October 7, 2013 – 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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