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 in highly sensitized patients. The study will include up to 20 highly sensitized patients on the UNOS (United Network for Organ Sharing) waiting list.
The principal investigator, Professor Stanley Jordan, is a leading expert in transplant immunology. Hansa Medical has previously announced that Dr. Jordan received a Letter to Proceed from the US food and Drug Administration (FDA) in response to an IND submitted in collaboration with the company.
IdeS will be added to Dr. Jordan’s standard protocols for sensitized patients, and all patients will undergo kidney transplantation. Patients will be followed for 6 months post transplantation.
“We are very pleased that the first patient in the study has been treated. IdeS has the potential to revolutionize the whole area of transplantation, especially in sensitized patients,” says Dr. Jordan.
“This collaboration with Dr. Jordan is an important component of the development of IdeS in kidney transplantation. In parallel, we are running other clinical studies for IdeS in Europe and plan for further studies in the US,” commented Christian Kjellman, CSO of Hansa Medical.
Source: Hansa Medical