Human Genome Sciences Initiates Clinical Development of Trail Receptor-2 Antibody for Treatment of Cancer
ROCKVILLE, Md., July 11 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI - News) announced today that it has received a clinical trial exemption (CTX) from the United Kingdom's Medicines and Healthcare products Regulatory Agency allowing the Company to begin clinical development of an agonistic human monoclonal antibody to TRAIL Receptor-2 (TRAIL-R2 mAb, HGS- ETR2). The Company now plans to proceed with a Phase 1 open-label, dose- escalating study in the United Kingdom to evaluate the safety and pharmacology of TRAIL-R2 mAb in patients with advanced tumors.
Company scientists will present the results of several in vitro and in vivo preclinical studies providing evidence that TRAIL-R2 mAb is an attractive candidate for development as a potential treatment for various cancers, at the 94th annual meeting of the American Association for Cancer Research (AACR), to be held in Washington, D.C., July 11-14, 2003. These data demonstrate that TRAIL-R2 mAb specifically binds to TRAIL Receptor-2, induces apoptosis and has anti-tumor activity in a broad range of tumor types, both as a single agent and in combination with chemotherapy.(1)(2)
Human Genome Sciences originally identified the TRAIL Receptor-2 protein as a member of the tumor necrosis factor family of proteins. Human Genome Sciences' own studies, as well as those of others, show that TRAIL Receptor-2 is expressed on a number of solid tumors and tumors of hematopoietic origin. It has been demonstrated that many such tumors are sensitive to killing by apoptosis induced by binding to TRAIL (tumor necrosis factor-related apoptosis-inducing ligand)(3) and by binding to TRAIL-R2 mAb1, 2. TRAIL-R2 mAb mimics the activity of native TRAIL. As such, it is considered an agonistic antibody.
TRAIL-R2 mAb is the fifth drug that Human Genome Sciences has in clinical development for use in cancer therapy. The other drugs include LymphoRad(TM) for the treatment of B-cell cancers(4), TRAIL-R1 mAb for the treatment of solid tumors and tumors of hematopoietic origin(5), Albuleukin(TM) for the treatment of solid tumors(6), and repifermin for the treatment of cancer therapy-induced mucositis(7). The Phase 1 clinical trial of TRAIL-R2 mAb will be Human Genome Sciences' first clinical trial to be conducted in Europe.
David C. Stump, M.D., Senior Vice President, Drug Development, said, "We are pleased that we are now able to proceed with clinical trials of TRAIL-R2 mAb in patients with advanced malignancies. We believe that TRAIL-R2 mAb has significant potential either as a single agent or in combination with chemotherapy for the treatment of a broad range of human malignancies. The results of preclinical studies to date demonstrate that TRAIL-R2 mAb triggers cell death through apoptosis, and inhibits tumor growth in a variety of cancer types including colon, breast, lung, and brain cancers, as well as reducing the size of tumors in certain cancers. We look forward to exploring the appropriate use of TRAIL-R2 mAb in treating a number of tumor types."
Craig A. Rosen, Ph.D., President, Research and Development, said, "Our preclinical results to date, along with evidence in the scientific literature, increasingly demonstrate that agonistic antibodies to the death domain- containing TRAIL receptors have the potential to provide novel treatment options to patients with a variety of tumor types. TRAIL-R2 mAb is a human monoclonal antibody that was selected to mimic the activity of TRAIL, but with greater specificity and considerably longer serum half-life. Like TRAIL, TRAIL-R2 mAb binds to TRAIL Receptor-2 and triggers cell death by apoptosis. As we continue our discovery, preclinical and clinical development progress, we expect to maintain our priority focus on cancer and immunology."
William A. Haseltine, Ph.D., Chairman and Chief Executive Officer, said, "I am pleased that our genomic approach to drug discovery has yielded another drug, an agonistic human monoclonal antibody to TRAIL Receptor-2, for the treatment of cancer."
The TRAIL-R2 agonistic human monoclonal antibody was made in a collaboration between Human Genome Sciences and Cambridge Antibody Technology.(8) The drug will be produced in the Human Genome Sciences clinical manufacturing facility located in Rockville, Maryland. Human Genome Sciences holds the commercial rights to the drug.
Human Genome Sciences also has a license agreement with the Pharmaceutical Division of Kirin Brewery Company, Ltd., under which Human Genome Sciences and Kirin are collaborating on the development and commercialization of agonistic human monoclonal antibodies to TRAIL Receptor-2.(9)
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 us at (301) 610-5790, extension 3550.
Human Genome Sciences is a company with the mission to treat and cure disease by bringing new gene-based drugs to patients.
HGS, Human Genome Sciences, LymphoRad, and Albuleukin 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.
Footnotes:
(1) TRAIL R2-mAb, a human agonistic monoclonal antibody to tumor necrosis
factor-related apoptosis inducing ligand receptor 2, affects tumor
growth and induces apoptosis in human tumor xenograft models in vivo.
Robin C. Humphreys, Ralph F. Alderson, Eliel Bayever, Kevin Connolly,
Gil H. Choi, Norma Lynn Fox, Gilles Gallant, Krzystof J.
Grzegorzewski, Viktor Roschke, Theodora W. Salcedo, Jing Zhang, Junli
Zhang, Vivian R. Albert. 94th AACR Annual Meeting. Abstract 642.
(2) TRAIL-R2 mAb, a human agonistic monoclonal antibody to tumor necrosis
factor-related apoptosis inducing ligand receptor 2, induces apoptosis
in human tumor cells. Ralph F. Alderson, Charles E. Birse, Kevin
Connolly, Gil H. Choi, Norma Lynn Fox, Gilles Gallant, Ina Han, Robin
C. Humphreys, Ron Johnson, Palanisamy Kanakaraj, Vikram Patel, Oxana
Pickeral, Laurie Pukac, Viktor Roschke, Theodora Salcedo, Tara Shah,
Junli Zhang, Vivian R. Albert. 94th AACR Annual Meeting. Abstract
963.
(3) Ashkenazi A. et al. Safety and anti-tumor activity of recombinant
soluble APO2 ligand. J Clin Inv July 1999; 104(2): 155-162.
(4) (HGSI Press Release) Human Genome Sciences Announces Clearance Of
Investigational New Drug Application For LymphoRad131, A New
Anticancer Drug For The Treatment Of B-Cell Tumors. May 14, 2002.
(5) (HGSI Press Release) Human Genome Sciences Initiates Trial of Novel
Anticancer Drug. April 30, 2002.
(6) (HGSI Press Release) Human Genome Sciences Initiates Trial Of
Albuleukin(TM), A Recombinant Human Protein For Treating Solid Tumor
Cancers. January 7, 2002.
(7) (HGSI Press Release) Results Of Phase 2 Repifermin Clinical Trial
Demonstrate Safety And Efficacy In Patients With Cancer Therapy-
Induced Mucositis. April 2, 2003.
(8) (HGSI Press Release) Human Genome Sciences And Cambridge Antibody
Technology Commit To Exclusive Development Of Antibody To Trail
Receptor-2. May 20, 2002.
(9) (HGSI Press Release) Human Genome Sciences Announces Joint Development
Of Antibody For The Treatment Of Cancer With Kirin. December 3, 2002. |
