Kiadis Pharma has started its phase III trial with its major products for blood cancer hematopoietic stem cell transplantation (HSCT) ATIR101.
After the Canadian governing medicines body Health Canada approved it, Kiadis will enroll just less than 200 patients with acute leukemia to participate in the third phase testing.
Kiadis will work with an international clinical contract research organizastion CTI Clinical Trial and Consulting Service on this research. The German Baden-Wuerttemberg-Hessen – Red Cross Blood Donor Service – will be the manufacturer in Europe, while A Caladrius Comany will produce ATIR101 for the Canada and the USA. Launching in Europe is expected in 2018.
Meanwhile, the ATIR201 for thalassemia has been cleared in the UK. It got approvals from the UK’s Medicines and Healthcare products Regulatory Agency, and from the Ethics Committees of the Royal Mancherster Children’s Hospital and Birmingham Children’s Hospital. In Germany, the Ethics Committee of Regensburg’s University has approved it, while the German national approval is pending.
Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis Pharma, said: “I am very excited that we have initiated our pivotal Phase III trial with ATIR101™. We have significant momentum now and the preparation of our MAA submission to EMA is progressing well. This work will bring our potentially life-saving treatment, which is also protected by Orphan Drug Designations in both Europe and the US, one step closer to patients with an anticipated launch in Europe in 2018.”