First Patient Treated in Hansa Medical’s Highdes-Study

Hansa Medical (STO:HMED) today announced that the first patient has been treated and subsequently transplanted in the pivotal multicenter study Highdes using IdeS to desensitize highly sensitized patients prior to kidney transplantation.
The Phase II study will include approximately 20 highly sensitized
patients awaiting kidney transplantation. Patients included in this new
study have either failed on previous attempts of desensitization or the
currently available methods are considered insufficiently effective.
The study is entitled “A Phase II Study to Evaluate the Efficacy of IdeS
(IgG endopeptidase) to Desensitize Transplant Patients with a Positive
Crossmatch Test” with the short name Highdes. The primary objective of
the study is to assess the efficacy of IdeS in creating a negative
crossmatch test in highly sensitized patients with a positive crossmatch
test to their available donor. Converting the crossmatch test will
enable transplantation in patients who would otherwise not qualify for
transplantation.
The study will also evaluate safety, kidney function and immunogenicity
during the 6-month follow-up period. The aim is to complete recruitment
of approximately 20 patients over a 12-month period.
“We are very pleased that the first patient has been treated in our
Hansa Medical-sponsored study with IdeS in the US. The study will
recruit patients with an urgent need for kidney transplantation. Several
of the patients have been on the waiting list for many years”, commented
Göran Arvidson, President and CEO of Hansa Medical AB.
It is expected that the study will provide pivotal data for filing a
Biologics License Application, i.e. an application to the US Food and
Drug Administration (FDA) for authorization to commercialize IdeS in the
US. Three US sites will recruit patients to the Highdes study:
Cedars-Sinai Medical Center in Los Angeles, The Johns Hopkins Hospital
in Baltimore and New York University School of Medicine in New York.
Hansa Medical is planning to add European sites to the study in order to
support the regulatory process at the European Medicines Agency, EMA,
for marketing authorization of IdeS in the European market.
More information about this study in refractory highly sensitized
patients is available at www.clinicaltrials.gov
under the identifier NCT02790437.
The information in this press release is disclosed pursuant to the EU
Market Abuse Regulation. The information was released for public
disclosure through the agency of the contact person stated below on
October 3, 2016 at 08.30 CET.
About highly sensitized patients
Approximately one third of the kidney patients in dialysis are
sensitized to human leukocyte antigens (HLA). The presence of antibodies
that react with a potential donor organ and create a positive crossmatch
test is a significant barrier to transplantation due to the risk of
acute antibody mediated rejection. Sensitized patients in general have
an increased waiting time for transplantation. Depending on the level of
HLA-immunization, some sensitized patients can be transplanted with
treatment procedures using for example plasmapheresis or intravenous
gamma globulin at specialized clinics. Patients included in the Highdes
study will have failed on previous attempts of desensitization or will
not be eligible for desensitization using currently available methods
due to the strength and breadth of their HLA antibodies. These patients
have one of the highest unmet medical needs in transplantation today.
About IdeS
IdeS, a unique molecule with a novel mechanism, is an enzyme that
specifically cleaves human IgG antibodies. IdeS has been evaluated in a
Phase I study in healthy subjects and in a Phase II study in sensitized
patients awaiting kidney transplantation demonstrating that IdeS is
highly effective in reducing anti-HLA antibodies to levels acceptable
for transplantation with a favorable safety profile. In addition to the
pivotal Highdes study, the efficacy and safety of IdeS in
transplantation are currently investigated in two on-going Phase II
studies in sensitized kidney patients in Sweden and the US. The Swedish
study will be completed in Q4 2016 and the U.S. study is estimated to be
completed during H1 2017. In addition to transplantation, IdeS has
potential applications in a variety of rare autoimmune diseases.
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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