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ROCKVILLE, Md., March 4 /PRNewswire-FirstCall/ -- Human Genome
Sciences,
Inc. (Nasdaq: HGSI) announced today that the U.S. Food and Drug
Administration
(FDA) has selected LymphoStat-B(TM) for the treatment of systemic
lupus
erythematosus for inclusion in the Continuous Marketing Application
(CMA)
Pilot 2 Program. Participation in the Pilot 2 Program is limited
to one
product for each review division within the Center for Drug Evaluation
and
Research (CDER) and the Center for Biologics Evaluation and Research
(CBER).
LymphoStat-B (human monoclonal antibody to B-lymphocyte stimulator,
BLyS(TM))
is the product selected for participation by CDER's Division of
Therapeutic
Biological Internal Medicine Products.
(Logo: http://www.newscom.com/cgi-bin/prnh/20010612/HGSLOGO )
Human Genome Sciences currently is conducting a Phase 2 clinical
trial to
determine the safety and efficacy of LymphoStat-B in patients with
active
systemic lupus erythematosus.(1) LymphoStat-B also is in Phase 2
clinical
trials in patients with rheumatoid arthritis.(2) In April 2003,
the FDA
designated LymphoStat-B a Fast Track Product for the treatment of
systemic
lupus erythematosus.
The Pilot 2 Program provides for frequent scientific feedback and
interactions based on a prospectively defined agreement between
the FDA and
participants. To be eligible for selection, drugs or biologics must
have been
designated as a Fast Track Product and have held an End of Phase
1 or
equivalent meeting with the FDA. According to the FDA, selection
of drugs or
biologics for participation was based on the FDA's overall assessment
of the
potential value of enhanced interaction, emphasizing the potential
public
health benefit resulting from the development of the product; the
likelihood
that the concentrated scientific dialogue will facilitate the availability
of
a promising novel therapy; and the applicant's demonstration of
commitment to
product development. The CMA concept and the Pilot 2 program were
outlined in
the June 2002 reauthorization of the Prescription Drug User Fee
Act of 1992
(PDUFA) and are intended to provide the FDA with important information
regarding whether enhanced communication and feedback can improve
the
efficiency of the drug development and review process and shorten
review time.
Sally D. Bolmer, Ph.D., R.A.C., Senior Vice President, Regulatory
Affairs,
said, "We are honored by the FDA's selection of LymphoStat-B
for the treatment
of systemic lupus erythematosus for participation in the Pilot 2
Program.
Participation in this program will allow for even greater interaction
with the
FDA regarding LymphoStat-B's development. We believe that this initiative
builds upon LymphoStat-B's Fast Track Product designation and an
already
positive and productive relationship with the FDA."
William A. Haseltine, Ph.D., Chairman and CEO, said, "As a
family,
autoimmune diseases such as lupus cause immense suffering to millions
of
patients worldwide. LymphoStat-B's participation in the Pilot 2
Program will
potentially further speed and clarify the regulatory pathway, and
may, in
turn, help bring a much-needed targeted treatment option to patients
suffering
from lupus."
LymphoStat-B is a human monoclonal antibody that specifically recognizes
and inhibits the biological activity of B-lymphocyte stimulator,
or BLyS.
BLyS is a naturally occurring protein discovered by Human Genome
Sciences that
is required for the development of B-lymphocyte cells into mature
plasma B
cells.(3) Plasma B cells produce antibodies, the body's first line
of defense
against infection. Laboratory studies have indicated that higher
than normal
levels of BLyS may contribute to the pathogenesis of autoimmune
diseases, such
as systemic lupus erythematosus and rheumatoid arthritis. (4)(5)(6)(7)
Autoimmune diseases are diseases in which the body is attacked by
its own
immune system.
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. Retrospective and prospective studies have shown elevated
levels of
BLyS in the blood of many patients with systemic lupus erythematosus,
and in
the blood and joint fluid of patients with rheumatoid arthritis.
(8)(9)(10)(11)(12) The results of prospective studies also now show
a
significant correlation of elevated levels of BLyS with systemic
lupus
erythematosus disease activity.(13) LymphoStat-B acts by: (1) binding
to
BLyS, (2) inhibiting BLyS's stimulation of B-cell development, and
(3)
restoring the potential for autoantibody-producing B cells to undergo
the
normal process of apoptosis (programmed cell death). In vitro and
in vivo
preclinical studies show that LymphoStat-B can reverse the immune
stimulatory
effects of BLyS.(14)
Systemic lupus erythematosus is a serious, life-threatening disease.
Between 200,000 and 500,000 people are diagnosed with systemic lupus
erythematosus each year in the United States alone. The disease
affects
between eight and ten times as many women as men. It can occur at
any age,
but appears mostly in young people between the ages of fifteen and
forty-five.
For more information on LymphoStat-B, see http://www.hgsi.com/products/LSB.html.
For more information on lupus, rheumatoid arthritis, or autoimmune
diseases,
visit The Lupus Foundation of America at http://www.lupus.org, the
Arthritis
Foundation at http://www.arthritis.org, or the National Institute
of Arthritis and
Musculoskeletal and Skin Diseases at http://www.niams.nih.gov.
For additional information on Human Genome Sciences, please visit
our web
site at http://www.hgsi.com.
For more information on the clinical trials evaluating LymphoStat-B
in
lupus patients, visit http://www.clinicaltrials.gov/ct/show/NCT00071487.
Health professionals or patients interested in inquiring about the
LymphoStat-
B trials or any other study involving HGSI products are encouraged
to inquire
via the Contact Us section of the Human Genome Sciences web site,
http://www.hgsi.com/products/request.html, or by calling (240) 314-4400,
extension
3550.
Human Genome Sciences is a company with the mission to treat and
cure
disease by bringing new gene-based protein and antibody drugs to
patients.
HGS, Human Genome Sciences, BLyS, and LymphoStat-B are trademarks
of Human
Genome Sciences, Inc.
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