Dutch Biopharma launches Phase III trial of Leukemia donor cell therapy

14-Feb-2017 - Last updated on 14-Feb-2017 at 12:12 GMT

Image: iStock/7activestudio

Amsterdam-based Kiadis Biopharma has received Health Canada approval to initiate a global Phase III trial for an allogenic stem cell therapy for acute leukemia.

Kiadis’ cell therapy, ATIR101 (Allodepleted T-cell ImmunotheRapeutics) is a modified infusion of a family member’s donated lymphocytes Kiadis is developing to treat leukemia.

By treating the donor cells, the firm looks to reduce the risk of the patient developing severe Graft-versus-Host-Disease, a life-threatening immune response.

Using the contract research organisation (CRO) CTI Clinical Trial and Consulting Services Inc., the trial will enrol 195 patients across 40-50 clinical sites, including the US and Canada.

Kiadis has since submitted the trial protocol to the US FDA and several European regulators, with anticipated launch of ATIR101 in 2018.

The contract manufacturing organisation PCT LLC has been partnered with Kiadis for producing ATIR101 for the US and Canada since June last year, using PCT’s Allendale, New Jersey facility.

For the European supply of the therapy, Kiadis will continue to work with the German Red Cross Blood Donor Service, Baden-Württemberg-Hessen e.V., which provided GMP manufacturing services for the Phase II trial of ATIR101.

Manfred Rüdiger, CEO of Kiadis Pharma said “We have significant momentum now and the preparation of our MAA submission to EMA is progressing well.”

Kiadis declined to comment further.