The trial was designed to evaluate the ability of FavId to induce humoral and cell-mediated immune responses, and to induce or maintain complete remission following autologous stem cell transplantation. In addition, the trial is evaluating the correlation of specific T-cell populations with immune responsiveness to FavId.
A total of 15 patients were treated in the trial, of which nine remain in complete remission up to 61 months post-transplant. The data showed that the majority of patients in the trial developed a rapid and tumor-specific immune response, often measured following a single dose of FavId.
“The data from this early stage trial suggests that FavId following high dose therapy and autologous stem cell transplantation is feasible, well tolerated and may be associated with durable remissions, even in heavily pretreated patients,” said Peter Holman, associate clinical professor of Medicine at the Moores University of California.
Autologous stem cell transplantation involves removing vital blood cells from a patient before administering large doses of chemotherapy. After chemotherapy, the blood cells are returned to the patient to speed recovery from the chemotherapy treatment.
Favrille has a special protocol assessment from the FDA for its phase III trial, and has also received fast track designation for FavId from the FDA.