Hansa Medical: Data Shows That One Dose of IdeS Has Favorable Effect and Completely Removes HLA-Antibodies

Regulatory News:

Hansa Medical AB (STO:HMED)

At Hansa Medical’s Capital Markets Day in Stockholm today, one of the world’s leading transplantation experts, Professor Stanley Jordan at Cedars-Sinai Medical Center, Los Angeles, will show data from one of his ongoing studies where highly sensitized patients are desensitized and treated with Hansa Medical’s lead candidate drug IdeS prior to transplantation.

Data will be shown from a patient with a PRA level of 100% who was treated and transplanted successfully in July this year.

The investigator-sponsored clinical phase II study, which was initiated and led by Dr. Jordan, 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, in which IdeS is added to Dr. Jordan’s standard protocols for sensitized patients, will include up to 20 highly sensitized patients on the UNOS (United Network for Organ Sharing) waiting list. All included patients will undergo kidney transplantation and be followed up for 6 months post transplantation.

"Data that we have seen in this patient is amazing, and could potentially revolutionize the whole area of transplantation, especially in sensitized patients”, said Dr. Jordan.

""It is promising to see that IdeS is so effective in removing HLA antibodies also in this difficult group of higly sensitized patients”, commented Lena Winstedt, Clinical Research Director.

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 November 13, 2015, at 08.45 CET.

About Dr. Stanley Jordan

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, Distinguished Alumni Award from the University of North Carolina-Chapel Hill School of Medicine and the inaugural PRISM Award from Cedars-Sinai for excellences in clinical research. Dr. Jordan is a member of national and international professional societies and has served on the editorial boards of numerous professional journals, he is also a member of Hansa Medical’s Medical Advisory Board

About IdeS

IdeS, a unique molecule with a novel mechanism, is a bacterial enzyme that cleaves human IgG antibodies. IdeS aims to degrade immunoglobulin G (IgG) and 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 favourable safety profile. During 2014, a Phase II study in 8 sensitized patients awaiting kidney transplantation was conducted. Preliminary data show that IdeS is effective in reducing anti-HLA antibody levels 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 applications in a variety of rare autoimmune diseases. IdeS is protected by several patents and results of studies with IdeS have been published in a number of peer reviewed medical and scientific journals.

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 Stockholm’s main list with Remium Nordic AB as Certified Adviser.

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