- Completion of enrollment in second Phase 3 trial expected by end of
summer -
- First Phase 3 data now expected by mid-2009, with all Phase 3 data
expected in fall 2009 -
ROCKVILLE, Md., April 22 /PRNewswire-FirstCall/ -- Human Genome
Sciences, Inc. (Nasdaq: HGSI) today announced that it has completed
enrollment and initial dosing in BLISS-52, one of two pivotal Phase 3
clinical trials of LymphoStat-B(R) (belimumab) in patients with active
systemic lupus erythematosus (SLE). LymphoStat-B 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 )
"We continue to be excited by LymphoStat-B's potential. Assuming it is
successful in Phase 3, we believe that LymphoStat-B could represent a
breakthrough in the treatment of SLE," said H. Thomas Watkins, President
and Chief Executive Officer, HGS. "With enrollment now completed in the
BLISS-52 trial, we are on track to have our first Phase 3 data for
LymphoStat-B available by mid-2009, and all Phase 3 data available in fall
2009."
BLISS-52 was initiated in May 2007, and has enrolled and randomized a
total of 867 patients at 90 clinical sites in 13 countries, primarily in
Asia, South America and Eastern Europe. Completion of enrollment for the
other pivotal Phase 3 trial of belimumab, BLISS-76, is expected by the end
of summer 2008. BLISS-76, which was initiated in February 2007, is being
conducted primarily in North America and Europe, and will enroll and
randomize a minimum of 810 subjects.
"The results of previous studies suggest that belimumab significantly
reduced SLE disease activity in serologically active patients," said
Professor Sandra V. Navarra, M.D., a principal investigator and head of
Rheumatology at the University of Santo Tomas, Manila, Philippines. "There
is a great need for better tolerated and more effective treatments for
lupus, and we look forward to seeing the first Phase 3 data for belimumab
by mid-2009."
About the LymphoStat-B Phase 3 Development Program
The LymphoStat-B 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 LymphoStat-B 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 LymphoStat-B Phase 3 program in collaboration with
GSK and leading international SLE experts.
"A total of nearly 1700 patients worldwide will be enrolled and
randomized in the Phase 3 trials of belimumab, making this the largest
double-blinded clinical development program ever undertaken in lupus
patients," said William W. Freimuth, M.D., Ph.D., Vice President, Clinical
Research - Immunology, Rheumatology and Infectious Diseases, HGS. "Today's
milestone brings us closer to seeing Phase 3 data that we hope will confirm
belimumab's promise as a potential treatment for patients with SLE. We are
grateful for the superb performance of our clinical investigators, whose
diligence made it possible to complete the enrollment of BLISS-52 ahead of
our fall 2008 projection."
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 are 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 study medication. Safety and tolerability are evaluated by an
independent Data Monitoring Committee throughout both studies.
About LymphoStat-B
LymphoStat-B (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 infections. 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. Pre-clinical and clinical studies
demonstrate that B-cell antagonists can reduce autoantibody levels and help
control autoimmune disease activity.
About the Collaboration with GSK
In August 2006, HGS and GSK entered into a co-development and
commercialization agreement under which HGS has responsibility for
conducting the LymphoStat-B Phase 3 trials, with assistance from GSK. The
companies will share equally in Phase 3/4 development costs, sales and
marketing expenses, and profits of any product commercialized under the
agreement.
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 (albinterferon
alfa-2b) for hepatitis C and LymphoStat-B (belimumab) for lupus. Phase 3
clinical trials of both drugs are ongoing.
ABthrax (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 for
the treatment of cancer. In addition, HGS1029, a small-molecule antagonist
of IAP (inhibitor of apoptosis) proteins, is expected to enter Phase 1
clinical trials for the treatment of cancer in early 2008. HGS also has
substantial financial rights to certain products in the GlaxoSmithKline
clinical development pipeline.
For information about HGS, please visit the Company's web site at
http://www.hgsi.com . Health professionals or patients interested in clinical
trials of HGS products may inquire via email to clinical_trials@hgsi.com,
or by calling (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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Related links:
http://www.hgsi.com
http://www.lupus.org http://www.elef.rheumanet.org
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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