ROCKVILLE, Md., Nov. 8 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. today announced that the interim results of a Phase 1b clinical trial demonstrate that HGS-ETR1 (mapatumumab) in combination with gemcitabine and cisplatin was well tolerated and could be administered safely and repetitively at the doses and schedules evaluated in patients with advanced solid tumors. Objective responses were observed in a number of patients in the study. The results were presented today in Prague at the AACR-NCI-EORTC International Conference on Molecular Therapeutics.
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“The interim results of the Phase 1b study demonstrate that the combination of HGS-ETR1 with gemcitabine and cisplatin was well tolerated and showed signs of clinical activity,” said Professor Dr. Elisabeth G.E. de Vries, Head of the Division of Medical Oncology, Groningen University Hospital (Groningen, The Netherlands). “Preclinical studies have shown that adding HGS-ETR1 to gemcitabine and cisplatin results in increased cytotoxicity. These data warrant further study of HGS-ETR1 in combination with chemotherapeutic agents in Phase 2 trials to evaluate its potential for use in the treatment of specific cancers.”
“We are encouraged by the observation of objective responses in a number of these very ill patients with advanced solid malignancies,” said Gilles Gallant, B. Pharm., Ph.D., Vice President, Clinical Oncology, Human Genome Sciences. “HGS-ETR1’s Maximum Tolerated Dose has not yet been reached, and patients continue to be enrolled in the Phase 1b study. Based on the clinical and preclinical results to date, we look forward to continuing the development of HGS-ETR1 in combination with chemotherapy in Phase 2 clinical studies.”
About the Phase 1b Results
Data are available on 32 patients with advanced solid malignancies who were enrolled in the Phase 1b open-label, dose-escalation, two-center clinical trial of HGS-ETR1 in combination with gemcitabine and cisplatin. The patients are enrolled into 4 HGS-ETR1 dose cohorts (1.0, 3.0, 10.0 or 20.0 mg/kg), with intravenous (I.V.) administration every 21 days. Patients also receive the chemotherapeutic agents, gemcitabine and cisplatin. The primary objective of the study, which is being conducted in The Netherlands, is to evaluate the safety and tolerability of escalating doses of the combination of gemcitabine and cisplatin. The data show that the combination was well tolerated and could be administered safely and repetitively at doses up to 20 mg/kg. The pharmacokinetics of gemcitabine and cisplatin were not influenced by HGS-ETR1 co-administration or vice versa. Objective responses were observed to date in 9 patients (7 confirmed), and stable disease was observed in 14 patients. A number of patients continue on study, and one patient with pancreatic cancer completed 54 weeks on study prior to disease progression. The Maximum Tolerated Dose has not been reached, and enrollment continues at 20 mg/kg.
About HGS-ETR1
HGS-ETR1 is an agonistic human monoclonal antibody that specifically binds to the TRAIL receptor-1 protein and directly induces apoptosis in human cancer cell lines expressing TRAIL receptor 1. It has anti-tumor activity in a broad range of tumor types, both as a single agent and in combination with chemotherapy. HGS-ETR1 was generated by HGS through a collaboration with Cambridge Antibody Technology.
GlaxoSmithKline has exercised its option under a June 1996 agreement to develop and commercialize HGS-ETR1 jointly with HGS. Under the terms of the agreement, GSK and Human Genome Sciences will share equally in Phase 3/4 development costs, and will share equally in sales and marketing expenses and profits of any product that is commercialized under the agreement, under a co- development and co-promotion agreement, the remaining terms of which are being negotiated by the parties.
About Human Genome Sciences
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 drugs.
The HGS clinical development pipeline includes drugs to treat hepatitis C, lupus, anthrax disease, cancer, rheumatoid arthritis and HIV/AIDS. The Company’s primary focus is rapid progress toward the commercialization of its two lead compounds, Albuferon(TM) for hepatitis C, and LymphoStat-B(TM) for lupus. Both compounds are expected to advance to Phase 3 clinical trials in 2006.
In June 2006, HGS announced that the U.S. Government exercised its option to purchase 20,000 doses of ABthrax(TM) for the treatment of anthrax disease. Other HGS compounds in clinical development include three TRAIL receptor antibodies for the treatment of hematopoietic and solid malignancies, in addition to an antibody to the CCR5 receptor for the treatment of HIV/AIDS.
For more information about HGS, please visit the Company’s web site at http://www.hgsi.com. For more information about HGS-ETR1, visit http://www.hgsi.com/products/ETR1.html. Health professionals or patients interested in inquiring about clinical trials involving HGS products in development are encouraged to inquire via the Contact Us section of the company’s web site, http://www.hgsi.com/products/request.html, or by calling us at (301) 610-5790, extension 3550.
HGS, Human Genome Sciences, ABthrax, Albuferon and LymphoStat-B are trademarks of Human Genome Sciences, Inc.
Safe Harbor Statement
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. In addition, the Company will continue to face risks related to animal and human testing, to the manufacture of ABthrax and to FDA concurrence that ABthrax meets the requirements of the ABthrax contract. If the Company is unable to meet the product requirements associated with the ABthrax contract, the U.S. Government will not be required to reimburse the Company for the costs incurred or to purchase any ABthrax doses. 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.
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CONTACT: Jerry Parrott, Vice President, Corporate Communications,+1-301-315-2777, or Kate de Santis, Director, Investor Relations,+1-301-251-6003, both of Human Genome Sciences, Inc.
Web site: http://www.hgsi.com/
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