Ongoing US study shows that IdeS allows for transplantation of highly sensitized patients
17 May 2016, 08:30
An initial evaluation of the ongoing US study with IdeS at Cedars Sinai Medical Center shows that IdeS completely eliminates donor specific antibodies and allows for kidney transplantation in all sensitized patients. These results are for four patients that were included in the US study as of January 2016. As of today 10 patients have been treated and subsequently transplanted. Initial results from the study will be presented by Professor Stanley Jordan, the study’s principal investigator, at the 2016 American Transplant Congress (ATC) in Boston on June 14 at 6:00 pm.
The ongoing Phase II study at Cedars Sinai Medical Center is an investigator-initiated study that is looking at the effects of IdeS in enabling kidney transplantation in highly sensitized kidney transplant patients. The study will eventually recruit up to 20 patients and of today a total of 10 patients have been treated and subsequently transplanted.
The conclusion from the initial evaluation is that IdeS treatment of highly sensitized (HS) patients completely eliminates donor specific antibodies (DSAs) present at transplant and allows for successful transplantation of HLA incompatible patients. IdeS is well tolerated without infusion-related side effects and no significant infections to date. IdeS may provide a rapid, effective and durable method to eliminate DSAs and transplant HS patients who are resistant to current desensitization (DES).
Professor Stanley Jordan will present data from all included patients in this study at the American Transplant Congress in Boston. A meeting abstract, including the first four patients, has been published ahead of the presentation at the ATC website:
The information in this press release is disclosed pursuant to the Swedish Securities Markets Act and/or the Swedish Financial Instruments Trading Act. The information was released for public disclosure on May 17, 2016 at 08.30 CET.
IdeS, a unique molecule with a novel mechanism, is an enzyme that specifically cleaves human IgG antibodies. During 2013, a Phase I clinical trial including 29 healthy subjects was conducted, demonstrating IdeS as efficacious and well tolerated with a favorable safety profile. During 2014, a Phase II study in 8 sensitized patients awaiting kidney transplantation was conducted. Data from the study show that IdeS is effective in reducing anti-HLA antibody levels in highly sensitized patients to levels acceptable for transplantation. IdeS is currently investigated in two on-going clinical trials in sensitized kidney patients in Sweden and in the US. The trials will involve 20-30 patients in total and the objective is to investigate IdeS’ efficacy and safety. 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 scientific journals.
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.