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Hansa Medical reports positive results from phase II study


The Hansa Medical candidate drug IdeS has enabled successful kidney transplantation, reports the company.

A successful kidney transplantation of an HLA sensitized patient has been accomplished following desensitization with the candidate drug IdeS at Uppsala University Hospital.

“We have demonstrated, for the first time, that IdeS can enable transplantation for patients burdened by anti-HLA antibodies as the primary obstacle to transplantation. I am very happy that we by treatment with IdeS, have managed to help this patient to become transplanted,” comments Emanuel Björne, CEO Hansa Medical AB.

According to Hansa MEdical, HLA sensitized patients rarely become transplanted due to the immediate risk of transplant rejection caused by donor specific anti-HLA antibodies. Following treatment with IdeS the now transplanted patient became eligible for deceased donor transplantation after treatment with IdeS. The cross match test, determining if the patient was compatible with the deceased donor, showed that the donor specific antibodies had been completely inactivated by the IdeS-treatment making the cross match negative. The patient was then successfully transplanted and the transplanted kidney is now perfectly functional.

The patient is enrolled in the ongoing Phase II study which is sponsored by Hansa Medical. The purpose of the ongoing Phase II-study is to explore IdeS’ safety and efficacy on anti-HLA antibodies in sensitized patients awaiting kidney transplantation. The objective is to generate significant clinical data in order to enable a pivotal phase III trial. In total, approximately 20 patients will be enrolled in two separate phase II studies planned to last until the second quarter of 2015.