|
|
| HUMAN GENOME SCIENCES REPORTS RESULTS OF PHASE 2 CLINICAL TRIAL OF HGS-ETR1 IN PATIENTS WITH ADVANCED NON-HODGKIN'S LYMPHOMA | |
|
- Clinical responses observed with single-agent HGS-ETR1 administration in patients with relapsed or refractory non-Hodgkin’s lymphoma - - Results support additional studies in combination with agents active in lymphoma - ROCKVILLE, Maryland – December 13, 2005 – Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that the results of a Phase 2 clinical trial 1-3 demonstrate that HGS-ETR1 (mapatumumab) is well tolerated and capable of producing clinical responses when administered as monotherapy in patients with advanced non-Hodgkin’s lymphoma. The results were presented today in Atlanta at the 47th Annual Meeting of the American Society of Hematology.4
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 (NHL). The 40 patients enrolled in the trial received up to six cycles of treatment in the absence of disease progression, with HGS-ETR1 administered as an intravenous infusion once every 21 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 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 were heavily pretreated, having received up to 12 previous cancer treatment regimens, with 69% (28/40) having received 3 or more prior regimens. Of note, 94% (34/36) of the subjects with B-cell NHL had received prior rituximab therapy. Anas Younes, M.D., Professor, Lymphoma/Myeloma, University of Texas M.D. Anderson Cancer Center, Houston, said, “The Phase 2 results presented today demonstrate that HGS-ETR1 has activity in heavily pretreated patients with relapsed or refractory non-Hodgkin’s lymphoma. These clinical results build on a growing body of preclinical evidence that HGS-ETR1 can induce cell death in a wide variety of cultured lymphoma and leukemia patient samples and cultured cell lines.5-11 The preclinical data, now supported by emerging clinical observation 2-4, 12-19, suggest that HGS-ETR1 has potential therapeutic value in lymphoid malignancies. The preclinical data also demonstrate that HGS-ETR1 enhances the tumor-killing activity of bortezomib and doxorubicin.2 Further study of HGS-ETR1 in lymphomas and leukemias is warranted, in combination with agents active in lymphoma.”
A poster presentation, entitled "In Vitro Synergistic Anti-Tumor Activity by Targeting TRAIL-R1 and CD20 Antigen by Combining HGS-ETR1 (Agonistic Human Monoclonal Antibody to TRAIL Receptor 1) and Rituximab Monoclonal Antibody Against Non-Hodgkin’s Lymphoma Cells,” presented the results of preclinical studies designed to determine the biological effects of rituximab when combined with either HGS-ETR1 or HGS-ETR2 in a panel of non-Hodgkin’s lymphoma (NHL) cell lines. 5 Data presented from in vitro studies demonstrate that the inhibition of NHL cell growth by HGS-ETR1 was greater than that achieved by HGS-ETR2 or rituximab alone in the cell lines tested. HGS-ETR1 (and to a much lesser degree, HGS-ETR2) was shown to be capable of inducing apoptosis, antibody-dependent cellular cytotoxicity and complement- mediated cytotoxicity in sensitive B-cell lymphoma cell lines. Data from in vivo animal studies suggest that rituximab in combination with HGS-ETR1 is the most effective in controlling lymphoma growth and improving survival as compared to single-agent rituximab, HGS-ETR2, or rituximab in combination with HGS-ETR2. David C. Stump, M.D., Executive Vice President, Drug Development, said, “The 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 responses observed in three patients and the stable disease observed in 30% of the patients who participated in this study are encouraging. These data, combined with other clinical and preclinical results to date support the continued study of HGS-ETR1 in combination with other agents, including rituximab, in patients with non-Hodgkin's lymphoma.” 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 a human monoclonal antibody 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 1.20-23 The TRAIL receptor-1 agonistic human monoclonal antibody, HGS-ETR1, was made in a collaboration between Human Genome Sciences and Cambridge Antibody Technology.24 Human Genome Sciences is a company with the mission to discover, develop, manufacture and market innovative drugs that serve patients with unmet medical needs, with a primary focus on protein and antibody drugs. For more information about HGS-ETR1, see http://www.hgsi.com/products/ETR1. 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. 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:
CONTACT: |