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| HUMAN GENOME SCIENCES REPORTS RESULTS OF PHASE 1 CLINICAL TRIAL OF HGS-ETR1 IN PATIENTS WITH ADVANCED SOLID TUMORS | |
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- Interim results of Phase 1 study of HGS-ETR2 also reported - ROCKVILLE, Maryland – April 18, 2005 – Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that the results of a Phase 1 clinical trial demonstrate the safety and tolerability of HGS-ETR1 (agonistic human monoclonal antibody to TRAIL receptor 1) in patients with advanced solid tumors, and support further evaluation of HGS-ETR1 in Phase 2 clinical trials, both as a single agent and in combination with chemotherapy. The results were presented yesterday at the 96th Annual Meeting of the American Association for Cancer Research in Anaheim, California. A poster entitled “A Phase 1, Pharmacokinetic (PK) Study of HGS-ETR1, an Agonistic Monoclonal Antibody to TRAIL-R1, in Patients with Advanced Solid Tumors,” presented data on 44 patients treated in an ongoing open-label, dose-escalation multi-center clinical trial.1 The median number of chemotherapeutic treatment regimens previously received by patients participating in the study was 6, and ranged as high as 12. The patients were enrolled into seven cohorts (0.01, 0.03, 0.1, 0.3, 1.0, 3.0, or 10.0 mg/kg) and received HGS-ETR1 administered intravenously on a 28-day or 14-day schedule. The primary purpose of the study, which was conducted in the United States, was to determine the safety, maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and pharmacokinetics of HGS-ETR1 in patients with relapsed or refractory advanced tumors. Disease response also is being evaluated. Available tumor tissue samples from patients participating in the trial will be evaluated for expression of the TRAIL receptor-1 protein using immunohistochemical (IHC) techniques. Results of the Phase 1 clinical trial demonstrate that HGS-ETR1 can be administered safely and repetitively to patients with advanced solid malignancies at doses up to and including 10 mg/kg intravenously every 14 or 28 days. The majority of adverse events were mild, Grade 1 or 2. The pharmacokinetics were generally dose-proportional with a mean terminal elimination half-life of 17 days across the dose cohorts. Stable disease was observed in 10 of these heavily pre-treated patients after two courses of HGS-ETR1. One subject with cancer of the appendix continued on study with stable disease after 16 courses of HGS-ETR1 at a dose of 10.0 mg/kg administered every 14 days. Accrual in the trial continues. Anthony W. Tolcher, M.D., Director of Clinical Research at the Institute for Drug Development of the Cancer Therapy and Research Center, and Clinical Professor, Department of Medicine/Oncology, University of Texas Health Sciences Center, San Antonio. Texas, said, “The Phase 1 clinical results presented at AACR demonstrate that HGS-ETR1 is well tolerated and can be safely and repetitively administered to patients with advanced solid tumors. Stable disease was observed in a number of patients. These data support the continued evaluation of HGS-ETR1 in Phase 2 clinical trials, both as a single agent and in combination with chemotherapy.” A poster entitled “A Phase 1 Clinical Trial of HGS-ETR2, a Fully Human Monoclonal Antibody to TRAIL-R2 in Patients with Advanced Solid Tumors” presented data on 19 patients treated to date in an open-label, dose-escalation clinical trial currently ongoing at 2 centers in the United States.2 All patients admitted to the trial have relapsed or refractory disease and have received prior anti-cancer treatments (chemotherapy, radiotherapy, or hormone therapy). Patients are being enrolled into five cohorts (0.1, 0.3, 1.0, 3.0, or 10.0 mg/kg) and receiving HGS-ETR2 administered intravenously every 14 days. The primary objective of the trial is to evaluate the safety and tolerability of HGS-ETR2 administered intravenously in patients with advanced malignancies. The pharmacokinetics of repeated doses of HGS-ETR2 will also be evaluated. To date, 19 patients have received a combined total of 89 courses of HGS-ETR2 over 4 dose levels (0.1-3.0 mg/kg). Interim results of the ongoing study demonstrate that HGS-ETR2 is well tolerated with minimal toxicities and that the MTD has not been reached. Stable disease has been observed in five patients. Preliminary data indicate that the pharmacokinetics of HGS-ETR2 are dose-proportional up to 1.0 mg/kg, with a terminal elimination half-life of five days. The trial continues to enroll patients at higher dose levels. David C. Stump, M.D., Executive Vice President, Drug Development, said, “The results of the Phase 1 study of HGS-ETR1 presented at AACR show that HGS-ETR1 is well tolerated and can be repetitively administered in patients with advanced solid tumors. I am encouraged by the observation of stable disease in ten of the forty-four patients in this study, all of whom had been treated previously with multiple courses of chemotherapy. These data are supportive of the broad clinical development program we have undertaken with HGS-ETR1. As we have announced previously, we have completed the enrollment and initial dosing 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.3-5 We anticipate having the results of all three of the Phase 2 studies of HGS-ETR1 in 2005. We also are encouraged by the early preliminary results emerging from the Phase 1 clinical trial of HGS-ETR2, which continues to accrue patients at higher doses. The results of companion Phase 1 studies of both HGS-ETR1 and HGS-ETR2 will be presented in May at the ASCO meeting, and we look forward to those data as well.” Human Genome Sciences, using genomic techniques, originally identified the TRAIL receptor-1 protein as a member 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 plays 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 protein 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. The TRAIL receptor-1 agonistic human monoclonal antibody, HGS-ETR1, was made in a collaboration between Human Genome Sciences and Cambridge Antibody Technology.6 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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