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| HUMAN GENOME SCIENCES REPORTS RESULTS OF PHASE 1 CLINICAL TRIALS OF HGS-ETR2 AND HGS-ETR1 IN PATIENTS WITH ADVANCED SOLID TUMORS | |
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- Results presented at ASCO provide support for further evaluation in Phase 2 clinical trials - ROCKVILLE, Maryland – May 17, 2005 – Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that the results of ongoing Phase 1 clinical trials demonstrate that HGS-ETR2 and HGS-ETR1 are well tolerated in patients with advanced solid tumors, and support further evaluation of each of the novel drug candidates in Phase 2 trials. The results were presented at the 2005 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida. A poster entitled “Phase 1 and Pharmacokinetic Study of HGS-ETR2, a Human Monoclonal Antibody to TRAIL-R2, in Patients with Advanced Solid Malignancies” presented data on 28 patients in an ongoing open-label, dose-escalation multi-center clinical trial.1 Patients participating in the study previously received multiple treatment regimens, including chemotherapy, immunotherapy, radiotherapy or hormone therapy. The patients were enrolled into 6 cohorts (0.1, 0.3, 1.0, 3.0, 10.0 or 20.0 mg/kg) and received HGS-ETR2 administered intravenously on a 21-day schedule. The primary purpose of the study, which was conducted in the United Kingdom, was to evaluate the safety and tolerability of escalating doses of HGS-ETR2 in patients with relapsed or refractory advanced tumors. Pharmacokinetics and tumor response also were evaluated. Results of the Phase 1 study demonstrate that HGS-ETR2 is well tolerated, with minimal toxicity, and can safely be administered intravenously every 21 days at doses < 10 mg/kg. Dose-limiting toxicity has been defined at a dose of 20 mg/kg. Human anti-human antibody formation has not been detected. The pharmacokinetics of HGS-ETR2 are linear across a 200-fold dose range (0.1-20.0 mg/kg). To date, stable disease has been observed in 8 of these heavily pre-treated patients after two courses of HGS-ETR2. Evaluation of HGS-ETR2 at the 10-mg/kg dose continues. Hillary Calvert, M.D., Professor of Medical Oncology, Newcastle University and a consultant at Newcastle General Hospital, Newcastle-upon-Tyne, UK, said, “The clinical results presented at ASCO demonstrate that HGS-ETR2 is well tolerated at doses as high as 10-mg/kg and can be safely and repetitively administered to patients with advanced solid tumors. The DLT dose has been identified as 20 mg/kg, and the 10-mg/kg dose cohort will be expanded to determine the maximum tolerated dose. We have observed stable disease in a number of these heavily pretreated and refractory patients. Phase 2 trials of HGS-ETR2 are warranted.” A poster entitled “HGS-ETR1, a Fully Human Monoclonal Antibody to the Tumor Necrosis Factor-Related Apoptosis-Inducing Ligand Receptor 1 (TRAIL-R1) in Patients with Advanced Solid Cancer: Results of a Phase 1 Trial” presented data on 34 patients treated to date in an open-label, dose-escalation clinical trial currently ongoing in Canada.2 All patients admitted to the trial have relapsed or refractory disease and received prior anti-cancer treatments (chemotherapy, radiotherapy, hormone therapy or immunotherapy). Patients are being enrolled into five cohorts (0.01, 0.03, 0.3, 3.0, 10.0 or 20.0 mg/kg) and receiving HGS-ETR1 administered intravenously every 28 days. The primary objective of the trial is to evaluate the safety and tolerability of repeated doses of HGS-ETR1 administered intravenously in patients with advanced solid tumors or non-Hodgkin’s lymphomas. Tumor response and the pharmacokinetics of repeated doses of HGS-ETR1 are also being evaluated. To date, 34 patients have received a median of 2 courses of HGS-ETR1. Interim results of the ongoing study demonstrate that HGS-ETR1 is well tolerated with only two dose-limiting toxicities observed. The MTD has not been reached. No antibodies to HGS-ETR1 have been detected. Stable disease has been observed in 8 patients. The observed mean terminal elimination half-life of HGS-ETR1 is 16 days. Accrual in the trial continues. David C. Stump, M.D., Executive Vice President, Drug Development, said, “The results of the Phase 1 studies of HGS-ETR2 and HGS-ETR1 presented at ASCO show that they are each well tolerated and can be repetitively administered in patients with advanced malignancies. I am encouraged by the observation of stable disease in a number of the patients in each of the studies, all of whom had been treated previously with multiple courses of anti-cancer therapy. The clinical data emerging from Phase 1 studies of HGS-ETR22-3 provide strong support for our plan to advance it to Phase 2 trials later this year. As we have announced previously, we have completed the enrollment of Phase 2 trials of HGS-ETR1 as a single agent in advanced non-small cell lung cancer, colorectal cancer and non-Hodgkin’s lymphoma, and we continue to enroll patients into two Phase 1b studies of HGS-ETR1 in combination with chemotherapy.4-6 We anticipate having the results of all three of the Phase 2 studies of HGS-ETR1 in 2005.” 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. 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.7 The second TRAIL receptor-2 human monoclonal antibody, HGS-TR2J, was made in a collaboration with the Pharmaceutical Division of Kirin Brewery Company, Ltd. 8, 9 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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