FREMONT, Calif.--(BW HealthWire)--Oct. 4, 2001-- SangStat Medical Corporation (Nasdaq:SANG - news) announced today that more than half of allogeneic transplant recipients with steroid-resistant graft-versus-host disease (GVHD) treated with at least four infusions of the anti-CD147 monoclonal antibody ABX-CBL demonstrated a complete or partial response in a Phase II study. Study results appear in the current issue of Blood.
Of the 51 patients receiving at least four infusions of ABX-CBL, 26 (51 percent) responded, 13 with complete responses as assessed by investigators using the International Bone Marrow Transplant Registry Index (IBMTR). Of the 59 total patients enrolled in the trial, 26 (44 percent) were alive six months after the start of ABX-CBL therapy.
The patients enrolled in the study had received an allogeneic transplant for malignant or nonmalignant disorders and developed steroid resistant GVHD. These patients also failed to respond to at least three days of treatment with corticosteroids, which is currently considered ``first line therapy.'' Acute GVHD is triggered when donor T lymphocytes respond to the recipient's tissues as foreign.
``These study results suggest that the anti-CD147 monoclonal antibody, ABX-CBL, is an effective agent for the treatment of steroid-resistant GVHD,'' said H. Joachim Deeg, MD, Member, Fred Hutchinson Cancer Research Center, and Professor of Medicine, University of Washington, Seattle. ``Since there is no current standard of therapy for steroid-refractory GVHD, we look forward to the future studies that will better define the role and effectiveness of ABX-CBL.''
``SangStat, as part of its co-development agreement with Abgenix, is currently studying ABX-CBL in another Phase II/III study. We expect those additional results to be available in the first quarter of 2003,'' said Jean-Jacques Bienaime, Chairman, CEO and President of SangStat.
Of the 34 serious adverse events reported in the study, only a case of liver failure was thought to be related to ABX-CBL, and six cases of myalgias (severe muscular pain or tenderness) were thought to be probably related.
Study Background
Patients were eligible for the trial if they had acute steroid resistant GVHD, which means they received at least three days of treatment with corticosteroids without improvement. Most patients had received treatment for longer periods of time.
In the dose-finding portion of the trial, 27 patients with steroid-refractory acute GVHD received ABX-CBL at 0.01 (presumed no effect dose), 0.1, 0.2, or 0.3 mg/kg per day; an additional 32 patients were given ABL-CBL at 0.2 or 0.15 mg/kg per day.
ABX-CBL treatment was started on average 47 days after transplantation. ABX-CBL infusions were given over two hours daily for seven consecutive days as part of an induction regimen that was followed by a maintenance regimen of two infusions per week for two weeks, for a total of 11 infusions in three weeks... |
