Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced the results
of its randomized Phase 2 trial of mapatumumab (HGS-ETR1) in combination
with the chemotherapy agents paclitaxel and carboplatin as first-line
therapy in advanced non-small cell lung cancer (NSCLC).
The results showed no difference in disease response or progression-free
survival for the combination that included mapatumumab vs. the control
group, and showed that mapatumumab was well tolerated in this study. HGS
expects to present the results in full at an appropriate scientific
meeting later in 2010.
About the HGS Oncology Program
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. It is the most advanced of any
product in development that targets the TRAIL apoptosis pathway.
Randomized Phase 2 chemotherapy combination trials are currently
underway to evaluate mapatumumab’s potential in the treatment of
advanced multiple myeloma and hepatocellular cancer. HGS expects to have
progression-free survival data available from the multiple myeloma study
in mid-2010, and expects to initiate the randomization stage of the
hepatocellular cancer study before the end of 2010. The Company is
investing strategically to expand and advance its oncology portfolio
around its expertise in the apoptosis, or programmed cell death, pathway.
In November 2009, HGS and Aegera Therapeutics announced the initiation
of a Phase 1 trial of HGS’ lead IAP inhibitor, HGS1029, as monotherapy
in patients with advanced lymphoid tumors. HGS1029 as monotherapy is
also being studied in an ongoing Phase 1 study initiated in 2008 in
patients with advanced solid tumors. The IAP inhibitors are a novel
class of compounds that block the activity of IAP (inhibitor of
apoptosis) proteins, allowing apoptosis to proceed and causing the
cancer cells to die. When IAP proteins are over-expressed in cancer
cells, they can help cancer cells resist apoptosis and resume growth and
proliferation. HGS plans to continue the study of HGS1029 both alone and
in combination with other anti-cancer agents, including mapatumumab.
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 lupus, hepatitis C,
inhalation anthrax and cancer.
The Company’s primary focus is rapid progress toward the
commercialization of its two lead drugs, BENLYSTA™ (belimumab) for
systemic lupus and ZALBIN™ (albinterferon alfa-2b) for hepatitis C.
Phase 3 development has been completed successfully for both BENLYSTA
and ZALBIN. The submission of marketing applications for BENLYSTA is
planned in the U.S., Europe and other regions in the second quarter of
2010. A BLA has been submitted for ZALBIN to the FDA in the United
States, and an MAA has been submitted under the brand name JOULFERON® to
the EMEA in Europe.
In April 2009, HGS completed the delivery of 20,000 doses of raxibacumab
to the U.S. Strategic National Stockpile for use in the event of an
emergency to treat inhalation anthrax. In July 2009, HGS secured a new
purchase order for 45,000 doses, and the Company delivered the first
5,600 doses to the Stockpile under the new order in November 2009.
HGS also has several drugs in earlier stages of development for
treatment of cancer, led by the TRAIL receptor antibody mapatumumab and
a small-molecule antagonist of inhibitor-of-apoptosis proteins. In
addition, HGS has substantial financial rights to certain products in
the GSK clinical pipeline including darapladib, in Phase 3 development
in patients with coronary heart disease, and Syncria® (albiglutide), in
Phase 3 development in patients with type 2 diabetes.
For more information about HGS, please visit the Company’s web site at www.hgsi.com.
Health professionals and patients interested in clinical trials of HGS
products may inquire via e-mail to medinfo@hgsi.com
or by calling HGS at (877) 822-8472.
HGS, Human Genome Sciences, BENLYSTA, and ZALBIN are trademarks of Human
Genome Sciences, Inc. Other trademarks referenced are the property of
their respective owners.
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 Human Genome Sciences’
unproven business model, its dependence on new technologies, the
uncertainty and timing of clinical trials, Human Genome Sciences’
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, Human Genome Sciences’ 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 SEC. 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.
