�Human Genome
Sciences, Inc. (Nasdaq: HGSI) 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).
"There is an urgent medical need for in force treatment options for
non small cell lung cancer because flow treatment strategies have only
a minimum 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 feature locally advanced or metastatic disease that is
currently incurable. We look forwards to evaluating the voltage of
mapatumumab plus chemotherapy to extend a unexampled approach to the first-line
treatment of this mortal disease."
The NSCLC trial is a randomized, multi-center, open-label Phase 2 study
to evaluate the efficaciousness and safety device of HGS-ETR1 in combination with
carboplatin and paclitaxel as first-line therapy in the discussion 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 information suggests that combining HGS-ETR1
with chemotherapy agents could be an effective access to the treatment of
a numeral of malignancies, including non-small cell lung cancer," aforesaid
Gilles Gallant, B. Pharm., Ph.D., Vice President, Clinical Research -
Oncology, HGS. "HGS-ETR1 is the to the highest degree advanced of any cartesian product in evolution
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 intervention 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 safe lead-in to a
randomised Phase 2 trial of HGS-ETR1 in combination with Nexavar
(sorafenib) in patients with advanced hepatocellular genus Cancer, which accounts
for 80-90% of all liver cancers.
-- The Company expects to get initial data available in the third
quarter of 2008 from a randomised 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 reenforcement a determination on whether
to march on HGS-ETR1 to Phase 3 development. It also is possible that a
sufficiently positive result from whatever 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 just about 75-80% of all
lung cancers. It is estimated that more than than clxx,000 new cases and more
than 160,000 deaths fall out annually in the United States alone. It is
currently the leading cause of genus 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 book 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 coaction with Cambridge Antibody
Technology. HGS is developing HGS-ETR1 as a potential discourse for a broad
range of cancers.
About Human Genome Sciences
The mission of HGS is to lend oneself 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 advancement toward the
commercialization of its iI key atomic number 82 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
bringing 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 as well 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.
HGS, Human Genome Sciences, ABthrax, Albuferon and LymphoStat-B ar
trademarks of Human Genome Sciences, Inc.
SAFE HARBOR STATEMENT
This annunciation contains modern statements inside the
substance 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
spirit, belief and expectations. These statements ar not guarantees of
future performance and are subject to certain risks and uncertainties that
are unmanageable to omen. Actual results may disagree materially from these
forward-looking statements because of the Company's unproven business
exemplar, its dependence on new technologies, the uncertainty and timing of
clinical trials, the Company's ability to develop and commercialize
products, its dependance on collaborators for services and gross, its
solid indebtedness and lease obligations, its ever-changing requirements
and costs associated with facilities, intense contest, the precariousness
of patent and cerebral property protection, the Company's dependence on
key direction and paint suppliers, the uncertainty of regulation of
products, the impact of future alliances or transactions and early risks
described in the Company's filings with the Securities and Exchange
Commission. In accession, the Company will continue to human face risks related to to
animal and human testing, to the construct 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
volition not incur any of the expected revenues relative to ABthrax. Existing
and prospective investors are cautioned not to place unreasonable reliance on
these innovative statements, which speak only as of today's date. 182% Genome Sciences undertakes no obligation to update or revise the
data contained in this declaration whether as a resolution of new
information, future events or circumstances or otherwise.
Human Genome Sciences, Inc
http://www.hgsi.com
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