- First Phase 3 data, from BLISS-52 trial, expected by mid-2009 -
- Data from second Phase 3 trial, BLISS-76, expected by fall 2009 -
ROCKVILLE, Md., Aug. 27 /PRNewswire-FirstCall/ -- Human Genome
Sciences, Inc. (Nasdaq: HGSI) today announced it has completed enrollment
and initial dosing in BLISS-76, the second of two pivotal Phase 3
randomized clinical trials of LymphoStat-B(R) (belimumab) in patients with
active systemic lupus erythematosus (SLE). Belimumab is being developed by
HGS and GlaxoSmithKline (GSK) under a co-development and commercialization
agreement entered into in August 2006.
(Logo: http://www.newscom.com/cgi-bin/prnh/20080416/HGSLOGO )
"If LymphoStat-B is successful in Phase 3, we believe that it could
represent a breakthrough in the treatment of patients suffering from SLE,"
said H. Thomas Watkins, President and Chief Executive Officer, HGS. "We
have now completed enrollment in both of our LymphoStat-B Phase 3 trials.
We are on track to have data from our first Phase 3 trial by mid-2009, and
data from our second Phase 3 trial by fall 2009. Assuming positive results,
we anticipate a BLA filing in the United States in the first half of 2010."
BLISS-76 was initiated in February 2007, and has enrolled and
randomized 826 patients at 133 clinical sites in 19 countries, primarily in
North America and Europe. In April 2008, BLISS-52, the first of the two
belimumab Phase 3 trials, completed the enrollment of 867 patients at 90
clinical sites in 13 countries, primarily in Asia, South America and
Eastern Europe.
"The BLISS studies are the largest double-blinded clinical trials ever
conducted in lupus," said Joan T. Merrill, M.D., F.A.C.R., study
investigator, and Program Chair, Clinical Pharmacology Research Program,
Oklahoma Medical Research Foundation. "There is a significant need for new
and more effective treatments for these patients, and we look forward to
having the belimumab Phase 3 results available in 2009."
About the LymphoStat-B (belimumab) Phase 3 Development Program
The belimumab Phase 3 development program includes two double-blind,
placebo-controlled, multi-center Phase 3 superiority trials -- BLISS-52 and
BLISS-76 -- to evaluate the efficacy and safety of belimumab plus standard
of care, versus placebo plus standard of care, in patients with
serologically active SLE. The design of the two trials is similar, but the
duration of therapy in the two studies is different -- 52 weeks for
BLISS-52 and 76 weeks for BLISS-76. The data from BLISS-76 will be analyzed
after 52 weeks in support of a potential Biologics License Application
(BLA). HGS designed the belimumab Phase 3 program in collaboration with GSK
and leading international SLE experts.
"The belimumab clinical investigators have done a tremendous job in
completing the randomization and initial dosing of BLISS-52 and BLISS-76 on
our original timeline, despite the size and complexity of these studies,"
said Ann L. Wang, Vice President, Clinical Operations, HGS. "They have
enrolled nearly 1700 patients worldwide into these Phase 3 trials. We are
one step closer to results that we hope will confirm belimumab's potential
to offer a significant new treatment option for patients with SLE."
The primary efficacy endpoint of BLISS-52 and BLISS-76 is the patient
response rate at Week 52, as defined by: a reduction from baseline of at
least 4 points on the SELENA SLEDAI disease activity scale; no worsening of
disease as measured by the Physician's Global Assessment (worsening defined
as an increase of more than 0.30 points from baseline); no new BILAG A
organ domain score (which would indicate a severe flare of lupus disease
activity) and no more than one new BILAG B organ domain score (which would
indicate a moderate flare of disease activity).
In each of the two Phase 3 trials, patients have been randomized to one
of three treatment groups: 1 mg/kg belimumab, 10 mg/kg belimumab, or
placebo. Patients are dosed intravenously on Days 0, 14 and 28, then every
28 days for the duration of the study. All receive standard of care therapy
in addition to the study medication. Safety and tolerability are evaluated
by an independent Data Monitoring Committee throughout both studies.
About LymphoStat-B (belimumab)
Belimumab is a human monoclonal antibody that specifically recognizes
and inhibits the biological activity of B-lymphocyte stimulator, or
BLyS(R). BLyS is a naturally occurring protein discovered by HGS that is
required for the development of B-lymphocyte cells into mature plasma B
cells. Plasma B cells produce antibodies, the body's first line of defense
against infection. In lupus and certain other autoimmune diseases, elevated
levels of BLyS are believed to contribute to the production of
autoantibodies - antibodies that attack and destroy the body's own healthy
tissues. The presence of autoantibodies appears to correlate with disease
severity. Preclinical and clinical studies demonstrate that B-cell
antagonists can reduce autoantibody levels and help control autoimmune
disease activity.
About Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a chronic, life-threatening
autoimmune disease. Approximately 1.5 million people in the United States
and approximately 5 million worldwide suffer from various forms of lupus,
including SLE. Lupus can occur at any age, but appears mostly in young
people ages 15 to 45. About 90 percent of those diagnosed with lupus are
women. African-American women are about three times more likely to develop
lupus, and it is also more common in Hispanic, Asian and American Indian
women. Symptoms may include extreme fatigue, painful and swollen joints,
unexplained fever, skin rash and kidney problems. Lupus can lead to
arthritis, kidney failure, heart and lung inflammation, central nervous
system abnormalities, inflammation of the blood vessels and blood
disorders. For more information on lupus, visit the Lupus Foundation of
America at http://www.lupus.org or the European Lupus Erythematosus Federation at
http://www.elef.rheumanet.org.
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
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. 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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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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