Human Genome
Sciences, Inc. (Nasdaq: HGSI) announced today that a Phase 2 clinical trial
demonstrated that LymphoStat-B(TM) (belimumab) significantly reduced
disease activity in patients with serologically active systemic lupus
erythematosus (SLE), exhibited clinically relevant bioactivity, and was
safe and well tolerated. Two oral presentations reported the complete study
results today in Amsterdam at the Annual European Congress of Rheumatology
(EULAR 2006).
"The substantial evidence now available from our Phase 2 clinical
program clearly supports the Phase 3 study of LymphoStat-B in patients with
systemic lupus erythematosus," said David C. Stump, M.D., Executive Vice
President, Drug Development, Human Genome Sciences. "We have also learned a
great deal from the data presented at EULAR about the clinical endpoints
available for the evaluation of new therapies for SLE, and about the
specific nature of their interaction with LymphoStat-B in lupus patients.
These results will guide the design of the Phase 3 trial of LymphoStat-B
that we and our collaborator, GlaxoSmithKline, expect to initiate in 2006.
We look forward to the opportunity to advance the development of what we
believe will become an important therapeutic option for patients suffering
from this debilitating disease."
"The Phase 2 study results demonstrate that LymphoStat-B is safe and
well tolerated, shows bioactivity across all doses studied, and reduces SLE
disease activity as evidenced by significant changes in multiple biomarkers
and clinical indicators. Further evaluation of LymphoStat-B for the
treatment of SLE in Phase 3 clinical trials is warranted," said Daniel J.
Wallace, M.D., Clinical Professor of Medicine, David Geffen School of
Medicine, UCLA (based at Cedars-Sinai Medical Center, Los Angeles).
"A potential patient response endpoint for the development of new drugs
to treat SLE has emerged from the Phase 2 trial of LymphoStat-B," said
Richard Furie, M.D., Chief, Division of Rheumatology and Allergy-Clinical
Immunology, North Shore Long Island Jewish Health System, Lake Success, NY,
and Associate Professor of Medicine, New York University School of
Medicine. "This response rate includes elements of the SELENA SLEDAI and
BILAG disease activity indices, as well as the Physician's Global
Assessment. These measures are well known to clinical investigators with
experience in SLE. The results presented today show that LymphoStat-B
significantly reduced disease activity versus the current standard of care
in serologically active patients, based both on this combined response rate
and on more traditional singular measures such as the SELENA SLEDAI, the
SF-36 quality of life assessment, and the Physician's Global Assessment."
About the Phase 2 Trial Results
The Phase 2 study was designed as a randomized, double-blind,
placebo-controlled, dose-ranging superiority trial to evaluate the safety,
tolerability and efficacy of LymphoStat-B plus standard of care, versus
placebo plus standard of care. The data presented demonstrate that
LymphoStat-B was safe and well tolerated, and produced statistically
significant reductions in disease activity versus placebo, as measured by:
- A significant reduction in anti-dsDNA autoantibodies among patients
positive for anti-dsDNA at baseline (p