Human Genome Sciences, Inc (HGSI) has completed enrolment and initial dosing in BLISS-76, the second of two pivotal phase-3 randomized clinical trials of LymphoStat-B (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.
"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 enrolment 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 enrolment 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, study investigator, and programme 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."
"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."
Belimumab 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 HGS that is required for the development of B-lymphocyte cells into mature plasma B cells.
Systemic lupus erythematosus (SLE) is a chronic, life-threatening autoimmune disease. 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. Symptoms may include extreme fatigue, painful and swollen joints, unexplained fever, skin rash and kidney problems.
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.