- First of three ongoing randomized chemotherapy combination trials to
evaluate HGS-ETR1 in the treatment of specific cancers -
ROCKVILLE, Md., Sept. 2 /PRNewswire-FirstCall/ -- Human Genome
Sciences, Inc. (Nasdaq: HGSI) today reported initial topline results from
an ongoing randomized Phase 2 clinical trial of its TRAIL receptor antibody
HGS-ETR1 (mapatumumab) in combination with bortezomib (Velcade) in patients
with advanced multiple myeloma. The initial data from the multiple myeloma
study show that HGS-ETR1 was well tolerated and suggest that disease
response was comparable for this combination vs. bortezomib alone.
(Logo: http://www.newscom.com/cgi-bin/prnh/20080416/HGSLOGO )
"We continue to be excited about HGS-ETR1 and our TRAIL receptor
antibody program," said David C. Stump, M.D., Executive Vice President,
Research and Development, HGS. "The TRAIL-mediated apoptosis pathway is an
important area of cancer research, and agonistic antibodies to this target
offer great promise. HGS-ETR1 is the most advanced of any product in
development that targets this pathway, with three randomized chemotherapy
combination trials currently ongoing to evaluate its potential for the
treatment of specific cancers. We look forward to maturing results from all
three trials. Taken together, these results will inform our decision on
whether to advance HGS- ETR1 to Phase 3 development."
Key Findings
The trial in advanced multiple myeloma is a randomized, multi-center,
open-label Phase 2 study to evaluate the efficacy and safety of HGS-ETR1
(mapatumumab) in combination with bortezomib in these patients. 104
patients are being treated in the study, which is being conducted in the
United States, Canada, Australia and India. Patients were randomized into
three treatment groups, with one group receiving bortezomib alone and two
groups receiving bortezomib in combination with mapatumumab (10 mg/kg or 20
mg/kg). Approximately 43% (15/35) of the patients in the group receiving
bortezomib alone were randomized contemporaneously with randomization of
the group receiving a combination of bortezomib and mapatumumab at 10
mg/kg. The remaining 57% (20/35) of the patients in the group receiving
bortezomib alone were randomized contemporaneously with randomization of
the group receiving a combination of bortezomib and mapatumumab at 20
mg/kg. The primary objective of the study is to evaluate disease response
to mapatumumab in combination with bortezomib, versus bortezomib alone, in
patients with relapsed or refractory multiple myeloma. Secondary objectives
include evaluation of progression-free survival, safety and tolerability,
and plasma concentrations of mapatumumab for use in a population
pharmacokinetic analysis.
Patients participating in the study had received a median of 2 previous
cancer treatment regimens. At baseline, 17.1% (6/35) of patients in the
treatment group receiving bortezomib alone had Stage 3 disease, vs. 40.6%
(13/33) in the group receiving the combination of bortezomib and
mapatumumab at 10 mg/kg, and 19.4% (7/36) in the group receiving the
combination of bortezomib and mapatumumab at 20 mg/kg. The initial data
show that mapatumumab was well tolerated and could be administered safely
and repetitively in combination with bortezomib, with no evidence of
increased toxicity in patients receiving the combination of bortezomib and
mapatumumab, vs. patients receiving bortezomib alone.
Overall, based on initial data, disease response was comparable among
the three treatment groups, including the following findings:
-- Three complete responses (8.3%; N=36) were observed among patients
in the treatment group receiving the combination of bortezomib and
mapatumumab at 20 mg/kg, vs. no complete responses in the group receiving
bortezomib alone.
-- Clinical responses were observed in 51.4% (18/35) of patients in the
treatment group receiving bortezomib alone (0 complete and 18 partial). The
response rate observed for bortezomib in the current study compares with a
response rate identified in the FDA-approved bortezomib label of
approximately 38%.
-- Clinical responses were observed in 50.0% (18/36) of patients in the
treatment group receiving the combination of bortezomib and mapatumumab at
20 mg/kg (3 complete and 15 partial).
-- Clinical responses were observed in 30.3% (10/33) of patients in the
treatment group receiving the combination of bortezomib and mapatumumab at
10 mg/kg (0 complete and 10 partial).
-- Stable disease was observed in approximately a third of the patients
on study and was comparable across all treatment groups.
The multiple myeloma study is ongoing, and 58 patients in this study
have not yet experienced disease progression and continue to be treated
and/or followed.
About the HGS-ETR1 Proof-of-Concept Trials
The HGS-ETR1 proof-of-concept phase currently includes three randomized
trials to evaluate its potential in combination with chemotherapy for the
treatment of specific cancers:
-- Patients in the multiple myeloma trial will continue on treatment
until the progression of disease, and HGS expects to have final data
available from this study in 2009, including data on the important
secondary endpoint of progression-free survival.
-- In August 2008, the Company completed the enrollment and initial
dosing of patients in a randomized Phase 2 trial of HGS-ETR1 (10 mg/kg or
30 mg/kg) in combination with paclitaxel and carboplatin as first-line
therapy in patients with advanced non-small cell lung cancer (NSCLC);
initial data from the study are anticipated in 2009.
-- 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.
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 Multiple Myeloma
Multiple myeloma is a cancer of the plasma cells in bone marrow. In the
United States each year, there are approximately 11,000 deaths from
multiple myeloma, with approximately 16,000 new cases diagnosed. It
accounts for about 10% of all hematologic cancers.
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
This e-mail address is being protected from spam bots, you need JavaScript
enabled to view it 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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Related links:
http://www.hgsi.com
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NewsCom: http://www.newscom.com/cgi-bin/prnh/20080416/HGSLOGO
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PRN Photo Desk, photodesk@prnewswire.com
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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, both of Human Genome Sciences, Inc.
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