Professor Stanley Jordan, a leading expert in transplant immunology, initiates IdeS-study in USA


Hansa Medical AB (publ) today announced that a new study with its lead compound
IdeS, currently in Phase II clinical studies, would be performed at Cedars-Sinai
Medical Center in Los Angeles, California. The first patient will be included
shortly.
Hansa Medical AB (publ) today announced that a new study with its lead compound
IdeS, currently in Phase II clinical studies, would be performed at Cedars-Sinai
Medical Center in Los Angeles, California. The first patient will be included
shortly.

As previously announced, Dr. Jordan, the principal investigator, has submitted
an IND for IdeS in collaboration with Hansa Medical, and a Letter to Proceed has
been received from the US Food and Drug Administration (FDA). The institutional
review board of Cedars-Sinai Medical Center has now approved the study.

The study is an open label study to assess the safety and efficacy of IdeS in
eliminating donor specific antibodies and thus prevent antibody-mediated
rejection in highly sensitized patients. The study will include up to 20 highly
sensitized patients on the UNOS (United Network for Organ Sharing) waiting list.
IdeS will be added to Dr. Jordan’s standard protocols for sensitized patients
and all patents will undergo kidney transplantation. Patients will be followed
for 6 months post transplantation.

“This important collaboration with Dr. Jordan is an acknowledgement that IdeS is
an exciting project that has the potential to revolutionize the whole area of
transplantation, especially in sensitized patients. In parallel, we are pursuing
other clinical studies for IdeS in Europe and the US”, commented Christian
Kjellman, CSO of Hansa Medical.

Dr. Stanley Jordan is a Director of Kidney Transplantation and Transplant
Immunology, Kidney and Pancreas Transplant Center and Director of Division of
Pediatric and Adult Nephrology at Cedars Sinai Medical Center, Los Angeles, USA.
Dr. Jordan's focus is on immunology and transplantation. He has performed
extensive research funded by dozens of research grants and awards, including
National Institutes of Health controlled clinical trials in kidney
transplantation.

Dr. Jordan has written hundreds of articles in scientific journals and authored
about two dozen book chapters. He was appointed by the National Institutes of
Health's National Institute of Allergy and Infectious Diseases to advise
Congress on the safety and efficacy of intravenous gamma globulin products. Dr.
Jordan has been principal investigator on 3 NIH Controlled Clinical Trials in
Kidney Transplantation.

He has received the Medical Sciences Award from the UCLA Alumni Association,
Gift of Life Award from the National Kidney Foundation, Established Investigator
Award from the American Society of Transplantation and Distinguished Alumni
Award from the University of North Carolina-Chapel Hill School of Medicine. Dr.
Jordan is a member of national and international professional societies and has
served on the editorial boards of numerous professional journals.

About IdeS
IdeS, a unique molecule with a novel mechanism, is a bacterial enzyme that
cleaves human IgG antibodies. IdeS degrades all IgG specifically, swiftly and
efficiently. IdeS has been tested for safety and efficacy in numerous in vitro
and in vivo models. During 2013, a Phase I clinical trial on 29 healthy subjects
was conducted, demonstrating IdeS as efficacious and well tolerated with a
favorable safety profile. During 2014 and 2015, a Phase II clinical trial in
sensitized patients awaiting kidney transplantation has been conducted.
Preliminary data shows that IdeS has very good efficacy in highly sensitized
patients on the kidney transplant waitlist. The study shows that IdeS has the
capacity to make sensitized patients eligible for transplantation by decreasing
HLA antibodies to levels acceptable for transplantation. In addition to
transplantation, IdeS has potential indications within a variety of rare
autoimmune diseases. IdeS is protected by several patents and has been published
in numerous peer review journals.

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 April 9, 2015 at 08.30 CET.
For further information, please contact:
Hansa Medical AB
Göran Arvidson, CFO and acting CEO
Mobile: 46 706-33 30 42
E-mail: goran.arvidson@hansamedical.com
www.hansamedical.com
About Hansa Medical AB
Hansa Medical is a biopharmaceutical company focused
on novel immunomodulatory enzymes. Lead project IdeS is an antibody-degrading
enzyme in clinical development, with potential use in transplantation and rare
autoimmune diseases. Other projects include HBP (a market introduced diagnostic
marker for severe sepsis) and EndoS (an antibody-modulating bacterial enzyme in
pre-clinical development). The company is based in Lund, Sweden. Hansa Medical's
share (HMED) is listed on Nasdaq First North in Stockholm with Remium Nordic AB
as Certified Adviser.

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