Favrille, Inc., a biopharmaceutical company developing patient-specific, active immunotherapies for the treatment of cancer, announced long-term follow-up data from a physician-sponsored Phase II clinical trial of FavId® following high dose therapy and autologous stem cell transplantation in patients with non-Hodgkin's lymphoma (NHL).
The data were reported at the annual meetings of the American Society for Blood and Marrow Transplantation (ASBMT) and the Center for International Blood and Marrow Transplant Research (CIBMTR) in Keystone, Colo., on Friday.
A total of 15 patients were treated in the trial, of which nine remain in complete remission up to 61 months post-transplant. The median number of prior regimens for all patients was three, ranging from one to 10.
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, M.D., principal investigator and Associate Clinical Professor of Medicine at the Moores University of California, San Diego (UCSD) Cancer Center, Blood and Marrow Transplantation Division.
Patient enrollment in this physician-sponsored trial began in November 2000. 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. 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.
At three months following transplantation, patients in the trial received the first of five monthly injections of FavId and were then assessed at fixed intervals.