�Human Genome
Sciences, Inc. (Nasdaq: HGSI) announced that it has completed the
enrollment and initial dosing of patients in a randomized Phase 2 run 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 pressing medical motive for effective treatment options for
not small cell lung cancer because current treatment strategies have merely
a minimal impact on survival," said Joachim von Pawel, M.D., a head
investigator in the study from the Asklepios Fachkliniken Munchen-Gauting,
Germany. "The legal age of patients who are newly diagnosed with non-small
cell lung cancer let locally ripe or metastatic disease that is
currently incurable. We look forth to evaluating the potential of
mapatumumab plus chemotherapy to offer a unexampled approach to the first-line
treatment of this venomous disease."
The NSCLC visitation is a randomized, multi-center, open-label Phase 2 study
to judge the efficaciousness and safety of HGS-ETR1 in combination with
carboplatin and paclitaxel as first-line therapy in the discussion of
advanced non-small cell lung crab (Stage IIIB or IV). 111 patients have
been randomly assigned to one of troika 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 access to the treatment of
a number of malignancies, including non-small cell lung cancer," aforementioned
Gilles Gallant, B. Pharm., Ph.D., Vice President, Clinical Research -
Oncology, HGS. "HGS-ETR1 is the most advanced of any ware in development
that targets the TRAIL apoptotic footpath. The NSCLC study is one of three
on-going HGS trials designed to evaluate combinations of HGS-ETR1 with
chemotherapeutical agents for the discourse of specific cancers."
About the HGS-ETR1 Proof-of-Concept Trials
The HGS-ETR1 proof-of-concept phase includes three randomised trials to
evaluate its potential in combination with chemotherapy for the treatment
of specific cancers:
-- Randomization and initial dosing of patients in the NSCLC subject have
now been completed.
-- In July 2008, HGS initiated dosing in the safety lead-in to a
randomised 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 information available in the third gear
quarter of 2008 from a randomised Phase 2 trial of HGS-ETR1 in combination
with Velcade (bortezomib) in sophisticated multiple myeloma. Patients in the
multiple myeloma study will carry on on handling until the progression of
disease.
These three trials, taken together, will accompaniment a decision on whether
to advance HGS-ETR1 to Phase 3 development. It also is possible that a
sufficiently positive issue from whatsoever one of the trials could trail to a
Phase 3 decision for that specific indication.
About Non-Small Cell Lung Cancer
Non-small cell lung cancer accounts for around 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 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 cover 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 quislingism with Cambridge Antibody
Technology. HGS is developing HGS-ETR1 as a potential treatment for a broad
compass of cancers.
About Human Genome Sciences
The mission of HGS is to practice great science and great medicine to
bring innovative drugs to patients with unmet medical needs.
The HGS clinical development grapevine 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 on-going.
ABthrax(TM) (raxibacumab) is in late-stage development for the
treatment of inhalation anthrax, and the Company is on track to start the
pitch 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 likewise 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 are
trademarks of Human Genome Sciences, Inc.
SAFE HARBOR STATEMENT
This annunciation contains modern statements inside the
import 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
design, belief and expectations. These statements ar not guarantees of
future performance and are topic to certain risks and uncertainties that
are difficult to auspicate. Actual results may differ materially from these
modern statements because of the Company's unproved business
model, its habituation on raw 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
solid indebtedness and lease obligations, its changing requirements
and costs associated with facilities, intense competition, the dubiety
of patent and intellectual property protection, the Company's dependence on
key direction and headstone 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 persist in to face risks related to
beast and human testing, to the manufacture of ABthrax and to FDA
concurrency that ABthrax meets the requirements of the ABthrax contract. If
the Company is ineffectual to forgather the production requirements associated with the
ABthrax get, the U.S. government will not be required to reimburse the
Company for the costs incurred or to purchase any ABthrax doses, and we
testament not get any of the expected revenues relative to ABthrax. Existing
and prospective investors are cautioned not to place undue reliance on
these advanced statements, which speak only as of today's date. 182% Genome Sciences undertakes no obligation to update or retool the
information contained in this proclamation whether as a resolution of new
information, future events or circumstances or otherwise.
Human Genome Sciences, Inc
http://www.hgsi.com
View drug information on Nexavar; Velcade.
More info
