Successful desensitization with IdeS in all recruited patients in ongoing US Phase II study


Hansa Medical AB (publ) today announced that additional data from the ongoing US
Phase II study with IdeS in kidney transplantation was presented at the 2016
American Transplant Congress (ATC) in Boston on June 14 at 6:00 pm (EDT).
The ongoing Phase II study at Cedars Sinai Medical Center is an investigator
-initiated study that is looking at the effects of IdeS in enabling kidney
transplantation in highly sensitized kidney transplant patients. Recruitment for
the study will be up to 20 patients.

The data presented by the study’s principal investigator Professor Stanley
Jordan, shows that all ten included patients have been successfully desensitized
and subsequently transplanted. The ten patients, recruited in the study between
July 18, 2015 and May 2, 2016, will be followed for 6 months post
transplantation for safety and graft function. At ATC, Professor Jordan
confirmed that all the transplanted kidneys are performing well and that
creatinine levels were normalized in all patients following transplantation.

This initial evaluation presented at ATC showed that the level of donor specific
antibodies (DSA) was reduced to zero in all patients within six hours of IdeS
treatment. One of the ten patients developed DSA and antibody mediated rejection
(ABMR) six months post-transplant and responded well to treatment. Post
treatment all DSAs were eliminated.

Professor Jordan concluded that the use of IdeS pre-transplant in highly
sensitized patients represents a robust and highly efficient technique to
eliminate DSAs. A single pre-operative dose administered to DSA positive
patients eliminated circulating DSAs, allowed transplantation without early ABMR
and, in conjunction with desensitization therapy based on intravenous
gammaglobulin and rituximab, resulted in long term DSA suppression.

"We are encouraged by the latest results that Dr. Jordan, from Cedars Sinai
Medical Center, presented at ATC," stated Göran Arvidson, CEO of Hansa Medical."
He continued, “Reducing the pre-transplantation anti-HLA antibody levels in ten
highly sensitized patients allowing transplantation is a significant step
forward for the development of IdeS.”

The information in this press release is disclosed pursuant to the Swedish
Securities Markets Act and/or the Swedish Financial Instruments Trading Act. The
information was released for public disclosure on June 15, 2016 at 08.30 CET.
For further information, please contact:
Hansa Medical AB
Göran Arvidson, CEO
Mobile: 46 70-633 30 42
E-mail: goran.arvidson@hansamedical.com
www.hansamedical.com
About Hansa Medical AB
Hansa Medical is a biopharmaceutical company focusing on novel immunomodulatory
enzymes. The lead project IdeS is an antibody-degrading enzyme in clinical
development, with potential use in transplantation and rare autoimmune diseases.
Additional projects focus on development of new antibody modulating enzymes, as
well as HBP, a diagnostic biomarker for prediction of severe sepsis at emergency
departments that is already introduced on the market. The company is based in
Lund, Sweden. Hansa Medical’s share (ticker: HMED) is listed on Nasdaq
Stockholm.

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