ROCKVILLE, Md., Dec. 20 /PRNewswire-FirstCall/ -- Human Genome
Sciences, Inc. (Nasdaq: HGSI) announced today that it has initiated dosing
of patients in a Phase 2 clinical trial of HGS-ETR1 (mapatumumab) in
combination with the chemotherapy agents paclitaxel and carboplatin as
first-line therapy in patients with advanced non-small cell lung cancer.
"The majority of patients who are newly diagnosed with non-small cell
lung cancer have locally advanced or metastatic disease that is currently
incurable," said Philip D. Bonomi, M.D., a principal investigator in the
study, and Section Director, Medical Oncology, Rush University Medical
Center, Chicago. "Fewer than half of these patients are candidates for
surgery. 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. We look forward to evaluating the
potential of HGS-ETR1 plus chemotherapy to offer a new approach to the
first-line treatment of this deadly disease."
HGS-ETR1 is a human monoclonal antibody to TRAIL receptor 1, a protein
involved in programmed cell death (apoptosis). The first randomized Phase 2
trial of HGS-ETR1 is currently underway in combination with bortezomib
(Velcade) in patients with advanced multiple myeloma. HGS expects to have
data available from the multiple myeloma study by mid-2008. In a separate
press release issued earlier today, HGS and Aegera Therapeutics Inc.
announced that HGS has acquired exclusive worldwide rights (excluding
Japan) to develop and commercialize AEG40826, a potent small-molecule
inhibitor of multiple proteins in the IAP (inhibitor of apoptosis) family
that is expected to enter Phase 1 clinical trials for the treatment of
cancer in early 2008. Preclinical studies have demonstrated that AEG40826
and the HGS TRAIL receptor antibodies exhibit dramatic synergistic activity
in a broad range of cancers. HGS plans to develop the TRAIL receptor
antibodies and IAP inhibitors in combination with one another and in
combination with other therapies.
"The TRAIL-mediated apoptosis pathway is an exciting area of cancer
research, and agonistic antibodies to this target offer great promise to
patients with a wide variety of cancers. HGS-ETR1 is the most advanced of
these antibodies, now with two randomized Phase 2 chemotherapy combination
trials ongoing," said David C. Stump, M.D., Executive Vice President,
Research and Development, HGS. "In addition, with the licensing and
collaboration agreement we announced today, we have strengthened our
oncology franchise by adding small-molecule drugs known as IAP inhibitors,
which also enhance apoptosis in cancer cells. We look forward to developing
our TRAIL receptor antibodies and IAP inhibitors in combination with one
another and in combination with other therapeutic agents."
About the Phase 2 Trial Design
This randomized, multi-center, open-label Phase 2 study is designed 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). Approximately 105
patients will be randomly assigned among 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.
About Previous Results in Non-Small Cell Lung Cancer
The results of in vitro and in vivo preclinical studies demonstrate
that: (1) TRAIL receptor 1 is differentially expressed on non-small cell
lung cancer (NSCLC) cells compared with normal cells; (2) HGS-ETR1
specifically binds TRAIL receptor 1 and triggers NSCLC cell death through
apoptosis; and (3) HGS- ETR1 inhibits NSCLC tumor growth in xenograft
models of NSCLC, and can induce significant tumor regression in certain
xenograft models of the disease. HGS preclinical studies also show that the
activity of HGS-ETR1 in NSCLC models may be increased by co-treatment with
chemotherapeutic agents including carboplatin and taxanes such as
paclitaxel. The results of preclinical studies in a number of NSCLC cell
lines showed that combining HGS-ETR1 with these chemotherapeutic agents
resulted in increased cancer cell-killing ability despite resistance to
mapatumumab alone, indicating a synergistic interaction. The combination of
carboplatin, a taxane and HGS-ETR1 resulted in tumor regression and
sustained reduction in tumor growth in a xenograft model of NSCLC that was
significantly greater than any of the agents alone or the combination of
carboplatin and a taxane.
The results of an earlier Phase 2 clinical trial of HGS-ETR1 to
evaluate its safety as a single agent in patients with advanced non-small
cell lung cancer showed that the drug was generally well tolerated and
could be administered safely and repetitively, with no patients
discontinuing therapy due to drug-related toxicity. Patients participating
in the earlier study previously had received up to seven different cancer
treatment regimens (median of three). Stable disease was observed in 29
percent (nine out of 32) of the patients treated, with eight patients
receiving at least four cycles of therapy. The results, along with the
results of other clinical and preclinical studies, support further
evaluation of HGS-ETR1 in combination with chemotherapy agents.
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. GlaxoSmithKline (GSK) has exercised its option under a
June 1996 agreement to develop and commercialize HGS-ETR1 jointly with HGS.
Under the terms of the agreement, GSK and HGS will share equally in Phase
3/4 development costs, and will share equally in sales and marketing
expenses and profits of any product commercialized.
Conference Call
HGS management will hold a conference call today to discuss this
announcement, as well as a separate announcement that HGS has acquired from
Aegera Therapeutics the exclusive worldwide rights (excluding Japan) to
develop and commercialize AEG40826, a potent small-molecule IAP inhibitor
that is expected to enter Phase 1 clinical trials for the treatment of
cancer in early 2008. The conference call will be held at 11 AM Eastern
time. Participants may listen to the call by dialing 888-233-8128 or
913-312-0734, passcode 2718784, five to 10 minutes before the start of the
call. A replay of the conference call will be available for several days by
dialing 888-203- 1112 or 719-457-0820, passcode 2718784. This conference
call also will be webcast. Interested parties who wish to listen to the
webcast should visit the HGS website at http://www.hgsi.com. The archive of the
conference call will be made available within a few hours after the call
and will remain available for several days.
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, anthrax disease, 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 anthrax disease, and the Company is on track to begin the
delivery in 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. Other HGS drugs in clinical development include two TRAIL receptor
antibodies for the treatment of cancers. The IAP inhibitor AEG40826 is
expected to enter Phase 1 clinical trials for the treatment of cancer in
early 2008.
For more information about Human Genome Sciences, please visit the
Company's web site at http://www.hgsi.com. For more information about HGS-ETR1,
see http://www.hgsi.com/products/ETR1.html. Health professionals interested in
more information about trials involving HGS products are encouraged to
inquire via the Contact Us section of the HGS website,
http://www.hgsi.com/products/request.html, or by calling (301) 610-5790, extension
3550.
ABthrax, Albuferon, LymphoStat-B, HGS and Human Genome Sciences are
trademarks of Human Genome Sciences, Inc.
HGS 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. 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
http://www.hgsi.com/products/ETR1.html
http://www.hgsi.com/products/request.html
Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/20010612/HGSLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
http://www.prnewswire.com/comp/121115.html /
CONTACT:
Jerry Parrott, Vice President, Corporate
Communications, +1-301-315-2777, or Kate de Santis, Director,
Investor Relations, +1-301-251-6003, both of Human Genome
Sciences, Inc.
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