ROCKVILLE, Md., Aug. 22 /PRNewswire-FirstCall/ -- Human Genome
Sciences, Inc. (Nasdaq: HGSI) 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).
(Logo: http://www.newscom.com/cgi-bin/prnh/20080416/HGSLOGO )
"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
http://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.
SOURCE Human Genome Sciences, Inc.
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Corporate Communications, +1-301-315-2777; Investors, Tim Barabe,
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+1-301-315-1780
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