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| HUMAN GENOME SCIENCES REPORTS RESULTS OF PHASE 2 CLINICAL TRIAL OF HGS-ETR1 IN PATIENTS WITH NON-SMALL CELL LUNG CANCER | |
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- Results support continued study of HGS-ETR1 in combination with chemotherapy in non-small cell lung cancer - ROCKVILLE, Maryland – July 5, 2005 – Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that the results of a Phase 2 clinical trial demonstrate that HGS-ETR1 (mapatumumab) is well tolerated and can be administered safely in patients with advanced non-small cell lung cancer (NSCLC).1 Stable disease was observed in a number of patients. Data on 32 patients were presented yesterday in Barcelona, Spain, at the 11th World Conference on Lung Cancer in a poster entitled “Results of a Phase 2 Trial of HGS-ETR1 (Agonistic Human Monoclonal Antibody to TRAIL Receptor 1) in Subjects with Relapsed/Recurrent Non-Small Cell Lung Cancer.” The trial, which was conducted in the United States, was a multi-center, open-label study to evaluate the efficacy, safety and tolerability of HGS-ETR1 in patients with relapsed or refractory non-small cell lung cancer.2 Patients enrolled in the trial received 10 mg/kg doses of HGS-ETR1 administered as an intravenous infusion 21 days apart in the absence of disease progression. The primary objective of the study was to evaluate tumor response. The secondary objectives were 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 had previously received up to 7 different cancer treatment regimens (median of 3). The data presented demonstrated that HGS-ETR1 was well tolerated, with no patients discontinuing therapy due to drug-related toxicity, and that HGS-ETR1 can safely be administered intravenously every 21 days at doses of 10 mg/kg. No immunogenic responses were observed. Stable disease was observed in 29% (9/32) of the patients treated, with 8 patients receiving at least 4 cycles of therapy. Plasma concentrations in the NSCLC study population were within the range expected based on previous Phase 1/2 experience. F. Anthony Greco, M.D., a study investigator and Medical Director of The Sarah Cannon Research Institute, Nashville, said, “The results of the Phase 2 study of HGS-ETR1 in heavily treated patients with advanced non-small cell lung cancer support further evaluation of HGS-ETR1 in this indication in combination with chemotherapeutic agents. Non-small cell lung cancer represents a significant medical need. Fewer than half of the patients who are newly diagnosed with non-small cell lung cancer are candidates for surgery. The majority of these patients present with incurable locally advanced or metastatic disease.3-4 We look forward to continuing to evaluate the potential of HGS-ETR1 in non-small cell lung cancer in combination with chemotherapeutic agents.” David C. Stump, M.D., Executive Vice President, Drug Development, said, “HGS-ETR1 is the subject of a broadening program of clinical study. We are pleased to have available the results of the Phase 2 trial in patients with advanced non-small cell lung cancer. The data presented demonstrate that HGS-ETR1 can be safely and repetitively administered to these patients. We note that stable disease was observed in a number of these very ill patients who had received multiple regimens of anti-cancer therapy before entering the study of HGS-ETR1. We recently reported the positive interim results of a separate Phase 2 clinical trial of HGS-ETR1 in advanced non-Hodgkin’s lymphoma and look forward to presentation of the complete results of that study at an appropriate scientific meeting later in 2005.5 The results of an ongoing Phase 2 study in patients with advanced colorectal cancer are also expected later this year.6 In addition, we continue to enroll patients into two Phase 1b trials of HGS-ETR1 in combination with chemotherapy.” 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 to specific TRAIL receptors 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. Human Genome Sciences’ own clinical and preclinical studies, along with published results in the scientific literature, demonstrate that agonistic antibodies to the death domain-containing TRAIL receptors have significant potential to provide novel therapeutic options to patients with a variety of cancer types, including non-small cell lung cancer.7-26 The TRAIL receptor-1 agonistic human monoclonal antibody, HGS-ETR1, and one of the company’s two TRAIL receptor-2 human monoclonal antibodies, HGS-ETR2, were made in a collaboration between Human Genome Sciences and Cambridge Antibody Technology.27 The second TRAIL receptor-2 human monoclonal antibody, HGS-TR2J, was made in a collaboration with the Pharmaceutical Division of Kirin Brewery Company, Ltd. 28-29 Non-small cell lung cancer accounts for approximately 75-80 percent of all lung cancers. It is estimated that more than 173,000 new cases and more than 160,000 deaths of lung cancer occurred in the United States in 2004. It is currently the leading cause of cancer death in this country in both men and women.3 For more information about HGS-ETR1, see www.hgsi.com/products/ETR1.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. The mission of Human Genome Sciences is to discover, develop, manufacture and market innovative drugs that serve patients with unmet medical needs, with a primary focus on protein and antibody products. 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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