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First patient treated in Hansa Medical’s Highdes-study

Regulatory information
Hansa Medical AB (publ) 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.