Hansa Medical has announced that the last patient, in the ongoing Phase II study at Uppsala University Hospital and Karolinska University Hospital in Huddinge, has been treated with IdeS and subsequently transplanted.
All 10 patients in the study have been transplanted following treatment with IdeS. The Phase II clinical study is a single arm, open label study and the study primarily evaluates safety and tolerability of the candidate drug IdeS in sensitized kidney transplantation patients. The study is also aimed at identifying an IdeS dose that results in anti-HLA antibody levels acceptable for transplantation within 24 hours from dosing.
“We are excited to have all of the included patients of the Phase II study in Sweden transplanted following treatment with IdeS and we are looking forward to see the results after follow-up,” stated Göran Arvidson, President and CEO of Hansa Medical.
The patients are followed for six months after transplantation for safety and kidney function. Results from the study are expected in Q4 2016.
Additionally, a US phase II study initiated by Professor Stanley Jordan is ongoing at Cedars Sinai Medical Center, Los Angeles. The US study is investigating IdeS in combination with high dose intravenous gamma globulin and anti-CD20 treatment. This study will include 10-20 patients and the patients will be followed for six months after transplantation.
In the beginning of April 2016, the US Food and Drug Administration (FDA) cleared Hansa Medicals IND application for IdeS in kidney transplantation. This enables Hansa Medical to start the next clinical study in the US scheduled to begin soon with the aim to complete recruitment in H1 2017.