ABX-CBL gets orphan drug designation for acute graft versus host disease

Monoclonal antibody product currently in Phase II/III trials

ABX-CBL, a murine anti-CD147 monoclonal antibody developed by Abgenix Inc. (Freemont, CA) and licensed by SangStat (Freemont, CA), was granted orphan drug designation for the treatment of acute graft-versus-host disease (GVHD) by the U.S. Food and Drug Administration (FDA). The antibody product is currently in a multi-center, randomized and controlled Phase II/III study in patients with GVHD, a condition that affects approximately 25% of patients that undergo an allogeneic bone marrow transplant.

In August 2000, Abgenix and SangStat entered into a global co-development, supply, and license agreement for ABX-CBL. Under the agreement, SangStat will have an exclusive worldwide license for the marketing and sale of ABX-CBL and, subject to the terms and conditions of the agreement, the right to commercialize other anti-CD147 antibodies. Abgenix will be responsible for manufacturing ABX-CBL. The two companies will share development responsibilities and costs—and any potential profits from sales of collaboration products—equally.

The Phase II/III study is designed to demonstrate statistically significant efficacy of a single dose level of ABX CBL in comparison to a control group of patients. In an earlier Phase II trial, 52% of patients receiving 0.1–0.3 mg/kg ABX-CBL survived at least 100 days following initiation of therapy, compared to 22% of patients receiving the presumed no effect dose of 0.01 mg/kg.

Abgenix is a biopharmaceutical company focused on the development and commercialization of antibody therapies for a variety of diseases.

SangStat is a biotechnology company building on its foundation in transplantation to discover, develop, and market therapeutic products in the transplantation, immunology, and hematology/oncology areas.

For more information, contact Therese Crozier of SangStat at 510-789-4331, or Ina Cu of Abgenix at 510-608-4662.

Edited by Jim Pomager
Assistant Editor, Pharmaceutical Online