ROCKVILLE, Md., March 31 /PRNewswire-FirstCall/ -- 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.
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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 pharmacoDiagnostic(TM) 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, http://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.
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences' current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the Company's unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company's ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with planned facilities, intense competition, the uncertainty of patent and intellectual property protection, the Company's dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company's filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
(1) C.M. Roach, A. Sharifi, J. Askaa, et al. Development of sensitive and
specific immunohistochemical assays for pro-apoptotic TRAIL-receptors.
95th Annual Meeting American Association Cancer Research (AACR):
(2) (HGSI Press Release) Human Genome Sciences Initiates Trial Of Novel
Anticancer Drug. April 30, 2002.
(3) (HGSI Press Release) Human Genome Sciences Updates Progress Of Six
Drugs In Clinical Trials At JPMorgan Conference. January 12, 2004.
(4) (HGSI Press Release) Human Genome Sciences Initiates Clinical
Development Of TRAIL Receptor-2 Antibody For Treatment Of Cancer.
July 11, 2003.
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Human Genome Sciences, Inc.
CONTACT: David C. Stump, M.D., Executive Vice President, DrugDevelopment, +1-240-314-4400, Jerry Parrott, Vice President, CorporateCommunications, +1-301-315-2777, or Kate de Santis, Director, InvestorRelations, +1-301-251-6003, all of Human Genome Sciences, Inc.