ROCKVILLE, Md., Aug. 22 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. today announced that it has completed the enrollment and initial dosing of patients in a randomized Phase 2 trial of HGS-ETR1 (mapatumumab) in combination with the chemotherapy agents paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer (NSCLC).
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“There is an urgent medical need for effective treatment options for non- small cell lung cancer because current treatment strategies have only a minimal impact on survival,” said Joachim von Pawel, M.D., a principal investigator in the study from the Asklepios Fachkliniken Munchen-Gauting, Germany. “The majority of patients who are newly diagnosed with non-small cell lung cancer have locally advanced or metastatic disease that is currently incurable. We look forward to evaluating the potential of mapatumumab plus chemotherapy to offer a new approach to the first-line treatment of this deadly disease.”
The NSCLC trial is a randomized, multi-center, open-label Phase 2 study to evaluate the efficacy and safety of HGS-ETR1 in combination with carboplatin and paclitaxel as first-line therapy in the treatment of advanced non-small cell lung cancer (Stage IIIB or IV). 111 patients have been randomly assigned to one of three treatment groups and treated with either the two-agent combination of carboplatin and paclitaxel or the three-agent combination of carboplatin, paclitaxel, and HGS-ETR1 at either 10 mg/kg or 30 mg/kg. HGS announced the initiation of the NSCLC trial In December 2007.
“A growing body of preclinical data suggests that combining HGS-ETR1 with chemotherapy agents could be an effective approach to the treatment of a number of malignancies, including non-small cell lung cancer,” said Gilles Gallant, B. Pharm., Ph.D., Vice President, Clinical Research - Oncology, HGS. “HGS-ETR1 is the most advanced of any product in development that targets the TRAIL apoptotic pathway. The NSCLC study is one of three ongoing HGS trials designed to evaluate combinations of HGS-ETR1 with chemotherapeutic agents for the treatment of specific cancers.”
About the HGS-ETR1 Proof-of-Concept Trials
The HGS-ETR1 proof-of-concept phase includes three randomized trials to evaluate its potential in combination with chemotherapy for the treatment of specific cancers:
-- Randomization and initial dosing of patients in the NSCLC study have now been completed.
-- In July 2008, HGS initiated dosing in the safety lead-in to a randomized Phase 2 trial of HGS-ETR1 in combination with Nexavar (sorafenib) in patients with advanced hepatocellular cancer, which accounts for 80-90% of all liver cancers.
-- The Company expects to have initial data available in the third quarter of 2008 from a randomized Phase 2 trial of HGS-ETR1 in combination with Velcade (bortezomib) in advanced multiple myeloma. Patients in the multiple myeloma study will continue on treatment until the progression of disease.
These three trials, taken together, will support a decision on whether to advance HGS-ETR1 to Phase 3 development. It also is possible that a sufficiently positive result from any one of the trials could lead to a Phase 3 decision for that specific indication.
About Non-Small Cell Lung Cancer
Non-small cell lung cancer accounts for approximately 75-80% of all lung cancers. It is estimated that more than 170,000 new cases and more than 160,000 deaths occur annually in the United States alone. It is currently the leading cause of cancer death in the U.S. in both men and women.
About HGS-ETR1
HGS-ETR1 (mapatumumab) is an agonistic human monoclonal antibody that directly induces cancer-cell death by specifically binding to and activating the protein known as TRAIL receptor 1. Using genomic techniques, HGS originally identified the TRAIL receptor 1 protein. The HGS-ETR1 antibody was generated by HGS through collaboration with Cambridge Antibody Technology. HGS is developing HGS-ETR1 as a potential treatment for a broad range of cancers.
About Human Genome Sciences
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs.
The HGS clinical development pipeline includes novel drugs to treat hepatitis C, lupus, inhalation anthrax, cancer and other immune-mediated diseases. The Company’s primary focus is rapid progress toward the commercialization of its two key lead drugs, Albuferon(R) (albinterferon alfa- 2b) for hepatitis C and LymphoStat-B(R) (belimumab) for lupus. Phase 3 clinical trials of both drugs are ongoing.
ABthrax(TM) (raxibacumab) is in late-stage development for the treatment of inhalation anthrax, and the Company is on track to begin the delivery in fall 2008 of 20,000 doses of ABthrax to the Strategic National Stockpile under a contract entered into with the U.S. Government in June 2006. HGS also has three drugs in clinical development for the treatment of cancer, including two TRAIL receptor antibodies and a small-molecule antagonist of IAP (inhibitor of apoptosis) proteins. In addition, HGS has substantial financial rights to certain products in the GSK clinical development pipeline.
For more information about HGS, please visit the Company’s web site at www.hgsi.com. Health professionals and patients interested in clinical trials of HGS products may inquire via e-mail to clinical_trials@hgsi.com or by calling HGS 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 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, and we will not receive any of the expected revenues relative to ABthrax. 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.
CONTACT: Media, Jerry Parrott, Vice President, Corporate Communications,
+1-301-315-2777; Investors, Tim Barabe, Senior Vice President and Chief
Financial Officer, +1-301-315-1780
Web site: http://www.hgsi.com/
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