PCT will supply study medication for the US part of Kiadis Pharma’s Phase III clinical trial with ATIR101™
Amsterdam, The Netherlands, June 21, 2016 – Kiadis Pharma N.V. (“Kiadis Pharma” or the “Company”) (Euronext Amsterdam and Brussels: KDS), a clinical stage biopharmaceutical company developing innovative T-cell immunotherapy treatments for blood cancers and inherited blood disorders, today announces that it has appointed PCT, LLC, A Caladrius Company (PCT), a subsidiary of Caladrius Biosciences (NASDAQ: CLBS), as Kiadis Pharma’s contract manufacturing organization (CMO) in the United States as Kiadis Pharma makes preparations for its Phase III clinical trial with lead product ATIR101™, on track to be initiated in the second half of 2016.
PCT and Kiadis Pharma already closely collaborated on improving and engineering the ATIR101™ manufacturing process for the Company’s Phase III trial. As a result, the technology and processes are already well established at PCT’s Allendale, New Jersey, US facility and PCT will supply study medication to the various Phase III clinical trial sites in the United States and Canada.
With regards to the European clinical sites for the Phase III trial, also expected to initiate in the second half of 2016, the Company already has a long-running and successful manufacturing collaboration with the German Red Cross Blood Donor Service, Baden-Wuerttemberg-Hessen, who provided GMP manufacturing services for Kiadis Pharma’s Phase II clinical studies with ATIR101™.
Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, commented: “We are pleased to select PCT as our CMO in the United States. The manufacture and supply of study medication for our Phase III clinical trial with ATIR101™ in the United States and Canada is a critical component to the successful and smooth running of our clinical study and having a partner who is well established and highly experienced, like PCT, is very important. PCT has been an excellent advisor and provider of process development to Kiadis Pharma in the past and we look forward to leveraging those efforts as we begin to broaden the activities of Kiadis Pharma in the United States.”
Robert A. Preti, PhD, President of PCT, and Chief Technology Officer and Senior Vice President, Manufacturing and Technical Operations of Caladrius Biosciences, commented: “We are very grateful for the opportunity to have participated in manufacturing development with the Kiadis Pharma team, working collaboratively for a number of years now to help them advance to this important milestone, the launch of a Phase III trial of ATIR101™. We now wish them success in the execution of their Phase III trial and will do our part to make that success a reality in the US and Canada.”