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


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.
För ytterligare information, vänligen kontakta:
Hansa Medical AB
Göran Arvidson, VD
Mobiltelefon: 46 70-390 85 30
E-mail: goran.arvidson@hansamedical.com
www.hansamedical.com

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