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Data from Hansa Medical’s First Phase II study of IdeS in Sensitized Kidney Transplantation Patients Presented in Oral Session at ESOT 2015

Regulatory information
Swedish investigators presented data from the first completed phase II study of IdeS in sensitized patients at the 17thCongress of the European Society for Organ Transplantation (ESOT) in Brussels. Data from the Hansa Medical sponsored study show that IdeS can effectively reduce anti-HLA antibodies to levels acceptable for transplantation. The primary as well as secondary objectives of the study were reached and IdeS has an acceptable safety profile.

“The data clearly support further development in transplantation and we are pleased that the investigators were given the opportunity to present these interesting and encouraging data at this renowned congress” states Dr. Christian Kjellman, Chief Scientific Officer of Hansa Medical AB.

In an oral presentation today, Tomas Lorant MD, PhD, at Uppsala University Hospital and principal investigator of the clinical study reported that the MFI of HLA antibodies were significantly reduced in all patients treated with IdeS. Even though it was not an objective of the study one patient with donor specific antibodies who was on the waiting list was offered a kidney and was subsequently successfully transplanted after having received 2 doses of IdeS at a 30-hour interval. Positive cytotoxic and flow cytometry crossmatch tests against the donor were converted to negative as a result of the IdeS treatment. The transplanted kidney is well functioning with no signs of antibody-mediated rejection. Four infections and one case of myalgia possibly related to IdeS were reported in the study. Dr. Lorant concludes that treatment with IdeS significantly reduces HLA antibody levels and that IdeS has an acceptable safety profile. An abstract with the title “Rapid removal of anti-HLA antibodies in immunized patients awaiting renal transplantation – A dose finding study of the IgG degrading enzyme IdeS” from the presentation is available at the ESOT congress website under Abstract Program: http://esot2015.esot.org/abstracts

The information in this press release is disclosed pursuant to the Securities Markets Act or the Financial Instruments Trading Act. The information was released for public disclosure on September 15, 2015 at 08.30 CET.