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| HUMAN GENOME SCIENCES REPORTS INTERIM RESULTS OF PHASE 2 CLINICAL TRIAL OF HGS-ETR1 IN PATIENTS WITH ADVANCED NON-HODGKIN'S LYMPHOMA | |
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- Partial responses observed with single-agent HGS-ETR1 administration - - Results support continued study of HGS-ETR1 in non-Hodgkin's lymphoma - ROCKVILLE, Maryland – June 13, 2005 – Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that the interim results of an ongoing Phase 2 clinical trial1 demonstrate that HGS-ETR1 (mapatumumab) is well tolerated and shows signs of clinical activity in patients with advanced non-Hodgkin's lymphoma. The results were presented over the weekend at the 9th International Conference on Malignant Lymphoma in Lugano, Switzerland.2 The Phase 2 clinical trial is a multi-center, open-label study to evaluate the efficacy, safety and tolerability of HGS-ETR1, an agonistic human monoclonal antibody to TRAIL receptor 1, in patients with relapsed or refractory non-Hodgkin's lymphoma. The 40 patients enrolled in the trial are receiving up to six cycles of treatment in the absence of disease progression, with HGS-ETR1 administered as an intravenous infusion once every twenty-one days. Patients were enrolled into two treatment groups, with 8 patients receiving HGS-ETR1 doses of 3 mg/kg and with 32 patients receiving HGS-ETR1 doses of 10 mg/kg. The study is ongoing with a number of patients still being treated and not yet evaluable. The objectives of the study are to evaluate disease activity and tumor response to HGS-ETR1 in patients with advanced non-Hodgkin's lymphoma, to evaluate the safety and tolerability of HGS-ETR1, and to determine plasma concentrations of HGS-ETR1 for use in a population pharmacokinetic analysis. Patients participating in the study have previously received multiple cancer treatment regimens. Data made available in an oral presentation 2 showed that HGS-ETR1 is well tolerated, with minimal toxicity, and can safely be administered intravenously every 21 days at doses up to 10 mg/kg. Partial responses have been observed in three patients to date. Data on one patient with relapsed follicular mixed-cell lymphoma were presented and indicated a 65% tumor regression. The tumor in this patient continues to decrease in size. The presentation, entitled “Activity of Selective Agonistic Monoclonal Antibodies to TRAIL Death Receptors R1 and R2 in Primary and Cultured Tumor Cells of Lymphoid Origin,” included data from preclinical studies designed to assess the in vitro activity of HGS-ETR1 and HGS-ETR2 in 31 primary lymphoma and leukemia samples and 9 lymphoma cell lines. 2 The data demonstrated that HGS-ETR1 and HGS-ETR2 inhibited tumor proliferation and induced apoptosis in more than two thirds of the samples. The two antibodies were not equally effective in individual tumor samples. HGS-ETR1 and HGS-ETR2 enhanced the anti-tumor activity of chemotherapy (bortezomib and doxorubicin). Both were able to induce apoptosis in a variety of primary and cultured lymphoma and leukemia cells. Anas Younes, M.D., Professor, Lymphoma/Myeloma, University of Texas M.D. Anderson Cancer Center, Houston, said, “A growing body of preclinical evidence demonstrates that the HGS-ETR1 and HGS-ETR2 monoclonal antibodies can induce cell death in a wide variety of cultured lymphoma and leukemia patient samples and cultured cell lines. 3-8 These data, now supported by emerging clinical observation 2, 9-14, suggest that HGS-ETR1 and HGS-ETR2 have potential therapeutic value in lymphoid malignancies. The preclinical data also demonstrate that HGS-ETR1 and HGS-ETR2 enhance the tumor-killing activity of bortezomib and doxorubicin.2 Further study of HGS-ETR1 and HGS-ETR2 in lymphomas and leukemias is warranted, both as single-agent therapies and in combination with chemotherapeutic agents.” David C. Stump, M.D., Executive Vice President, Drug Development, said, “The interim results of the Phase 2 study of HGS-ETR1 in patients with advanced non-Hodgkin's lymphoma show that HGS-ETR1 is well tolerated and shows signs of clinical activity in these patients. The partial responses observed in three patients are encouraging, and it is worth noting that several patients in the non-Hodgkin's lymphoma study continue to be treated. We look forward to presentation of the full data from this study at an appropriate scientific meeting later this year. We also anticipate that the results of our ongoing Phase 2 trials of HGS-ETR1 in advanced non-small cell lung cancer and colorectal cancer will be available in 2005.15-16” Human Genome Sciences, using genomic techniques, originally identified the TRAIL receptor-1 and TRAIL receptor-2 proteins as members of the tumor necrosis factor receptor super-family. The company's own studies, as well as those conducted by others, show that TRAIL receptor 1 and TRAIL receptor 2 play a key role in triggering apoptosis, or programmed cell death, in tumors. Human Genome Sciences took the approach of developing human monoclonal antibodies that would bind the receptor and stimulate the TRAIL receptor-1 and TRAIL receptor-2 proteins to trigger apoptosis in cancer cells, in much the same way that the native TRAIL ligand (tumor necrosis factor-related apoptosis-inducing ligand) triggers it, but with the advantage of a longer half-life and an exclusive specificity for TRAIL receptor 1 or TRAIL receptor 2, respectively.17-21 The TRAIL receptor-1 agonistic human monoclonal antibody, HGS-ETR1, and one of the company's two TRAIL receptor-2 human monoclonal antibodies, HGS-ETR1, were made in a collaboration between Human Genome Sciences and Cambridge Antibody Technology.22 The second TRAIL receptor-2 human monoclonal antibody, HGS-TR2J, was made in a collaboration with the Pharmaceutical Division of Kirin Brewery Company, Ltd.23, 24 For more information about HGS-ETR1, see www.hgsi.com/products/ETR1.html. For more information about HGS-ETR2, see www.hgsi.com/products/ETR2.html. 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 (240) 314-4400, 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. ### Footnotes:
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