- Primary study objectives include evaluation of safety and tolerability,
as well as selection of a recommended dose for Phase 2 trials -
ROCKVILLE, Md., May 30 /PRNewswire-FirstCall/ -- Human Genome Sciences,
Inc. (Nasdaq: HGSI) today announced that it has initiated dosing in a Phase
1 clinical trial to evaluate the safety and tolerability of its lead IAP
inhibitor, HGS1029, as monotherapy in patients with advanced solid tumors.
(Logo: http://www.newscom.com/cgi-bin/prnh/20080416/HGSLOGO )
"We are pleased to initiate this first human study of HGS1029, and we
look forward to studying our IAP inhibitors both alone and in combination
with other anti-cancer agents, including our TRAIL receptor antibodies,"
said Gilles Gallant, B. Pharm., Ph.D., Vice President, Clinical Research -
Oncology, HGS.
HGS acquired exclusive worldwide rights (excluding Japan) to develop
and commercialize HGS1029 (formerly AEG40826) and other IAP inhibitors from
Aegera Therapeutics, Inc. in December 2007. When IAP proteins are
over-expressed in cancer cells, they may help cancer cells resist
apoptosis, or programmed cell death, and resume growth. The IAP inhibitors
developed by Aegera, including HGS1029, are members of a new class of
designed small-molecule drugs that block the biological activity of IAP
proteins, thus allowing apoptosis to proceed and causing the cancer cells
to die. Preclinical studies have shown that HGS1029 has significant
anti-tumor activity alone and in combination with other anti-cancer agents,
including the HGS TRAIL receptor antibodies, against a number of cancer
types.
About the Phase 1 Trial Design
The primary objectives of the Phase 1 open-label, dose-escalation study
are to evaluate the safety and tolerability of HGS1029 as monotherapy in
patients with advanced solid tumors, and to select a recommended dose for
Phase 2 studies. Secondary objectives include documenting possible
anti-tumor activity and determining HGS1029's pharmacokinetic profile.
HGS1029 will be administered as a 15-minute infusion once weekly for 3
consecutive weeks followed by a week off. Up to 40 patients will be treated
in the study, with 15-20 patients treated in the dose-escalation phase.
About the HGS Oncology Portfolio
HGS is investing strategically to expand and advance its oncology
portfolio around its leading expertise in the apoptosis pathway. HGS has
initiated new chemotherapy combination trials of HGS-ETR1 (mapatumumab),
added the new opportunity to develop and commercialize HGS1029 and other
IAP inhibitors, and reacquired the rights to its TRAIL receptor antibodies.
HGS-ETR1, the Company's antibody to TRAIL receptor 1, is the most advanced
of any product in development that targets the TRAIL apoptosis pathway.
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) 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. Other HGS drugs in clinical development include two TRAIL receptor
antibodies and a small-molecule antagonist of IAP (inhibitor of apoptosis)
proteins for the treatment of cancer. In addition, HGS has substantial
financial rights to three products in the GlaxoSmithKline 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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Related links:
http://www.hgsi.com
Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/20080416/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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