Human Genome Sciences,
Inc. (Nasdaq: HGSI) today announced that dosing has begun in BLISS-52, the
second of two pivotal Phase 3 clinical trials of LymphoStat-B(R)
(belimumab) in patients with active systemic lupus erythematosus (SLE).
Dosing in BLISS- 76, the first Phase 3 trial of LymphoStat-B, began in
February 2007. LymphoStat-B is being developed by HGS and GlaxoSmithKline
(GSK) under a definitive development and commercialization agreement
entered into in August 2006.
"We believe that LymphoStat-B could address the significant medical
need of patients suffering from SLE, and we are pleased to announce that
both Phase 3 trials of this novel and potentially important compound are
now underway," said H. Thomas Watkins, President and Chief Executive
Officer, HGS. "These trials, assuming that they are successful, will
provide the pivotal data to support global marketing applications for
LymphoStat-B."
BLISS-52 is being conducted primarily in Asia, South America and
Eastern Europe. BLISS-76 is being conducted primarily in North America and
Europe.
"There is a great need for safer and more effective treatments for
lupus," said Professor Sandra V. Navarra, M.D., a principal investigator
and head of Rheumatology at the University of Santo Tomas, Manila,
Philippines. "The results of previous studies suggest that LymphoStat-B
significantly reduced SLE disease activity in serologically active
patients. We look forward to further evaluation of LymphoStat-B in larger
numbers of patients in the Phase 3 trials."
SLE is a chronic, life-threatening autoimmune disease. It is estimated
that approximately 1.5 million people in the United States and
approximately 5 million worldwide suffer from various forms of lupus,
including SLE.
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. Each of the Phase 3 trials will enroll
approximately 810 patients. 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. HGS designed the LymphoStat-B Phase 3
program in collaboration with GSK and leading international SLE experts.
"The Phase 3 trials of LymphoStat-B will enroll more than 1600 patients
worldwide, 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. "We expect these trials to enroll patients
throughout 2007, and expect to complete enrollment of both of our Phase 3
trials of LymphoStat- B in 2008."
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 will be randomized to one
of three treatment groups: 1 mg/kg LymphoStat-B, 10 mg/kg LymphoStat-B, or
placebo. Patients will be dosed intravenously on Days 0, 14 and 28, then
every 28 days for the duration of the study. All will receive standard of
care in addition to study medications. Safety and tolerability will be
evaluated by an independent Data Monitoring Committee throughout both
studies.
About LymphoStat-B
LymphoStat-B 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, rheumatoid arthritis 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.
LymphoStat-B was generated by HGS through a collaboration with
Cambridge Antibody Technology. It has received a "fast-track product"
designation from the FDA for its potential use in treating SLE and has been
selected for participation in the FDA's Continuous Marketing Application
Pilot 2 Program, in which the FDA provides companies with more extensive
feedback to improve the efficiency of the drug development and approval
process. The FDA and the European Agency for the Evaluation of Medicinal
Products have agreed that the Phase 3 trial design is suitable to support
regulatory submissions and potential approval for marketing.
About the Collaboration with GSK
In August 2006, HGS and GSK entered into a definitive 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 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, rheumatoid arthritis and
HIV/AIDS. The Company's primary focus is rapid progress toward the
commercialization of its two lead compounds, Albuferon for hepatitis C and
LymphoStat-B for lupus -- both of which are in Phase 3 clinical trials.
In June 2006, HGS announced that the U.S. government exercised its
option under an existing contract to purchase 20,000 doses of ABthrax(TM)
for the treatment of anthrax disease. Other HGS drugs in clinical
development include two TRAIL receptor antibodies for the treatment of
hematologic and solid malignancies, in addition to an antibody to the CCR5
receptor for the treatment of HIV/AIDS.
For more information about HGS, visit hgsi. For more
information on LymphoStat-B, visit hgsi/products/LSB.html. Health
professionals or patients interested in LymphoStat-B clinical trials or
other studies involving HGS products may inquire via the "Contact Us"
section of the Company's Web site, hgsi/products/request.html.
HGS, Human Genome Sciences, ABthrax, Albuferon, BLyS and LymphoStat-B
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 planned 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. 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.
Human Genome Sciences, Inc.
hgsi