Clinical Trials - October 13, 2016
Hansa Medical’s first patient treated with IdeS
Hansa Medical announces that the first patient has been recruited and treated in a Phase II clinical study with IdeS in the acute autoimmune disease acquired Thrombotic Thrombocytopenic Purpura (TTP) at University College Hospital in London. Acquired TTP is a severe and acute autoimmune blood disorder in which the presence of autoantibodies can result in […]
Clinical Trials - April 20, 2016
Hansa Medical completes Phase II study
Hansa Medical has announced that the last patient, in the ongoing Phase II study at Uppsala University Hospital and Karolinska University Hospital in Huddinge, has been treated with IdeS and subsequently transplanted. All 10 patients in the study have been transplanted following treatment with IdeS. The Phase II clinical study is a single arm, open label study […]
Drug Development Pharma - April 3, 2016
FDA clears Hansa Medical’s IND application for IdeS in kidney transplantation
Hansa Medical announces that the US Food and Drug Administration (FDA) has completed the safety review of the company’s Investigational New Drug application (IND) and has concluded that the proposed clinical investigation can proceed. This enables Hansa Medical to start a clinical study to primarily evaluate IdeS’ efficacy in making highly sensitized kidney patients with […]
Clinical Trials - August 17, 2015
First patient transplanted in Hansa Medical study
Hansa Medical has 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 […]
Clinical Trials - August 18, 2014
Hansa Medical reports positive results from phase II study
The Hansa Medical candidate drug IdeS has enabled successful kidney transplantation, reports the company. A successful kidney transplantation of an HLA sensitized patient has been accomplished following desensitization with the candidate drug IdeS at Uppsala University Hospital. “We have demonstrated, for the first time, that IdeS can enable transplantation for patients burdened by anti-HLA antibodies […]
Clinical Trials - May 6, 2014
Hansa Medical gets green light for kidney study
The Swedish Medical Products Agency has approved Hansa Medical’s clinical phase II-study application with the drug candidate IdeS. The study’s primary objective is to investigate IdeS’ efficacy and safety in sensitised kidney transplantation patients. The Phase II-study will be conducted at Uppsala University Hospital and is scheduled to begin in the second quarter of 2014. The […]
