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.
For further information, please contact:
Hansa Medical AB
Lena Winstedt, Ph.D, Clinical Research Director
Mobil: 46 76-858 15 06
E-mail: lena.winstedt@hansamedical.com
Göran Arvidson, CEO
Mobile: 46 70-390 85 30
E-mail: goran.arvidson@hansamedical.com
www.hansamedical.com
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.
