Unexpected Clinical Results Cause Hansa Medical to Terminate Phase II With IdeS in Acquired TTP
MALMÖ, Sweden, Dec. 21, 2016 /PRNewswire/ -- Hansa Medical AB (Nasdaq Stockholm: HMED), a biopharmaceutical company focusing on novel immunomodulatory enzymes, announces The second Swedish open label Phase II IdeS-study conducted at Uppsala University Hospital and Karolinska University Hospital in Huddinge is now complete with all IdeS treated patients transplanted.
Hansa Medical AB today announced completion of a Phase II study entitled "A Phase II Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Intravenous Ascending Doses of IdeS in Kidney Transplantation" in which 10 sensitized kidney patients were given IdeS prior to transplantation. The primary and secondary objectives were met with IdeS in the study.
Dr. Steven Glazer, Chief Medical Officer at Hansa Medical said, "We are encouraged by these results. These data further support our belief that our novel immunomodulatory enzyme holds significant therapeutic value for sensitized patients in need of lifesaving transplantation. We plan to move forward with continued recruitment of patients to our ongoing multi-center study with IdeS in highly sensitized kidney transplantation patients, allowing us to accumulate additional data and further evidence of the value of IdeS and our clinical program."
Data generated from this trial have been submitted for peer review in a scientific journal.
This information is information that Hansa Medical AB (publ) is obliged to make public pursuant to the Financial Instruments Trading Act. The information was submitted for publication at 09:45am CET on December 21, 2016.
CONTACT:
For further information, please contact:
Hansa Medical AB (Publ)
Emanuel Björne, Vice President Business Development and Investor Relations
Mobile: +46707175477
E-mail: emanuel.bjorne@hansamedical.com
Göran Arvidson, CEO
Mobile: +4670633 3042
E-mail: goran.arvidson@hansamedical.com
Cord Communications, Stockholm
Mikael Widell
Mobile: +46 70 311 9960
Lars Wahlström
Mobile: +46 73 434 0771
FTI Consulting, London
Julia Phillips / Stephanie Cuthbert / Hanna Skeppner: +44 203 727 1000
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Hansa Medical announces successful completion of a Phase II clinical trial of IdeS in sensitized kidney patients
SOURCE Hansa Medical
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