Hansa Medical AB (publ) today announced that the first patient in an
investigator-sponsored Phase II clinical study at Cedars-Sinai Medical Center in
Los Angeles, California, has been treated with IdeS and subsequently
transplanted.
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.
The principal investigator, Professor Stanley Jordan, is a leading expert in
transplant immunology. Hansa Medical has previously announced that Dr. Jordan
received a Letter to Proceed from the US food and Drug Administration (FDA) in
response to an IND submitted in collaboration with the company.
IdeS will be added to Dr. Jordan’s standard protocols for sensitized patients,
and all patients will undergo kidney transplantation. Patients will be followed
for 6 months post transplantation.
“We are very pleased that the first patient in the study has been treated. IdeS
has the potential to revolutionize the whole area of transplantation, especially
in sensitized patients” said Dr. Jordan.
“This collaboration with Dr. Jordan is an important component of the development
of IdeS in kidney transplantation. In parallel, we run other clinical studies
for IdeS in Europe and plan for further studies in the US”, commented Christian
Kjellman, CSO of Hansa Medical.
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 August 11, 2015, at 08.00 CET.
For further information, please contact:
Hansa Medical AB
Christian Kjellman, Ph.D
Chief Scientific Officer
Mobile: +46 705 717417
E-mail:
christian.kjellman@hansamedical.com
Göran Arvidson, CEO
Mobile: +46 70-390 85 30
E-mail: goran.arvidson@hansamedical.com
www.hansamedical.com
(http://www.hansamedical.com)www.clinicaltrials.gov/ct2/show/NCT02426684?term=I
d
eS&rank=4
www.nejm.org/doi/full/10.1056/NEJMoa0707894
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 and 2015, a Phase II clinical trial in sensitized patients
awaiting kidney transplantation has been conducted. 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 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.
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.
