DakoCytomation has acquired exclusive worldwide rights to develop and commercialize pharmacogenomic diagnostic tests in the field of oncology

Human Genome Sciences, Inc. announced today a license agreement with DakoCytomation A/S (Glostrup, Denmark), under which DakoCytomation has acquired exclusive worldwide rights to develop and commercialize pharmacogenomic diagnostic tests in the field of oncology based on the TRAIL Receptor-1 (TRAIL-R1) and TRAIL Receptor-2 (TRAIL-R2) proteins.

Results describing the new immunohistochemical (IHC) diagnostic tests will be presented today at the Annual Meeting of the American Association for Cancer Research (AACR) in Orlando.  Scientists from DakoCytomation and Human Genome Sciences will report that study results demonstrate that the new assays distinguish between expression of TRAIL-R1 and TRAIL-R2, and are suitable for further exploration of the relationship between TRAIL-R1 and TRAIL-R2 expression and therapeutic response to TRAIL-R1 and TRAIL-R2 agonistic antibodies.¹

According to the terms of the agreement, DakoCytomation will be the exclusive partner of Human Genome Sciences for any licensed IHC diagnostic product based on the TRAIL-R1 or TRAIL-R2 proteins, and will not sell or provide such products to any third party without prior approval from Human Genome Sciences or until certain commercial or regulatory approval milestones are achieved.

The TRAIL (tumor necrosis factor related apoptosis-inducing ligand) Receptor-1 and TRAIL Receptor-2 proteins were identified by Human Genome Sciences.  The Company is developing agonistic human monoclonal antibodies that specifically bind to the TRAIL-R1 and TRAIL-R2 proteins, respectively, for potential use in the treatment of a broad range of cancers.

The TRAIL-R1 and TRAIL-R2 receptors are found on the surface of a number of solid tumor and hematopoietic cancer cells.  Human Genome Sciences currently is conducting Phase 1 clinical trials of its TRAIL-R1 agonistic human monoclonal antibody (HGS-ETR1) to evaluate the safety and pharmacology of the drug in patients with advanced solid tumors and hematological malignancies.²  The Company plans to advance HGS-ETR1 to Phase 2 clinical trials in 2004.³  Human Genome Sciences also is currently conducting Phase 1 clinical trials to evaluate the safety and pharmacology of its TRAIL-R2 agonistic human monoclonal antibody (HGS-ETR2) in patients with advanced tumors.^{3, 4}  The Company plans to complete enrollment of one Phase 1 trial of HGS-ETR2 in 2004. 

Jes Ostergaard, CEO of DakoCytomation, said, "This is an important agreement for DakoCytomation as we work to expand our business in the pharmacoDiagnosticª arena.  We are excited to partner with one of the leading biotechnology companies in the world in developing yet another tool to help physicians identify patients for treatment with new targeted therapies."

David C. Stump, M.D., Executive Vice President, Drug Development, Human Genome Sciences, said, "DakoCytomation is the leader in developing clinical tests to help assess candidates for specific targeted therapies.  The immunohistochemical tests under development as a result of the collaboration between our companies will play an important role in clinical trials in exploring the correlation between TRAIL Receptor-1 and TRAIL Receptor-2 expression and clinical response to treatment of various cancers with TRAIL-R1 and TRAIL-R2 agonistic human monoclonal antibodies."

Health professionals interested in more information about trials involving HGSI products are encouraged to inquire via the Contact Us section of the Human Genome Sciences web site, www.hgsi.com/products/request.html, or by calling (301) 610-5790, extension 3550.

Human Genome Sciences is a company with the mission to treat and cure disease by bringing new gene-based protein and antibody drugs to patients.

HGS and Human Genome Sciences are trademarks of Human Genome Sciences, Inc.