Human Genome Sciences Initiates Trial of a New Drug for Systemic Lupus Erythematosus and Other Autoimmune Diseases
ROCKVILLE, Md., Nov. 1 /PRNewswire/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI - news) announced today that the U.S. Food & Drug Administration has approved its Investigational New Drug application to begin clinical trials of LymphoStat-B(TM)(TM), as a potential new treatment for autoimmune diseases. Human Genome Sciences will now proceed with a Phase 1 clinical trial in patients with systemic lupus erythematosus. The trial will be a multi-center, dose-escalation study to determine the safety and pharmacology of the drug in adult patients who are receiving standard therapies. In the future, LymphoStat-B may also be tested in patients with other autoimmune diseases, such as rheumatoid arthritis, immune thrombocytopenic purpura, and Sjogren's syndrome.
Systemic lupus erythematosus is a serious, life-threatening disease. Between 200,000 and 500,000 people are diagnosed with systemic lupus each year in the United States alone. The disease affects between eight and ten times as many women as men. It may occur at any age, but appears mostly in young people between the ages of fifteen and forty-five. Symptoms may include extreme fatigue, painful and swollen joints, unexplained fever and kidney problems. Systemic lupus erythematosus can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels and blood disorders.
LymphoStat-B acts by inactivating a natural immune stimulator, the B Lymphocyte Stimulator (BLyS(TM)). Many patients that suffer from systemic lupus erythematosus and rheumatoid arthritis have elevated levels of BLyS in their blood or joint fluid``.(1) Laboratory studies show that LymphoStat-B can reverse the immune stimulatory effects of BLyS.
William Stohl, M.D., Ph.D., Professor of Medicine, Division of Rheumatology, University of Southern California, said, ``Studies in laboratory models of lupus, as well as in human lupus patients, suggest that elevated levels of BLyS may have a significant role in systemic lupus erythematosus. Furthermore, laboratory studies of rheumatoid arthritis and studies in human rheumatoid arthritis patients raise the possibility that elevated BLyS levels may contribute to this disease as well. LymphoStat-B, by virtue of its ability to neutralize BLyS activity, may prove to be an effective treatment approach for patients suffering from systemic lupus, rheumatoid arthritis and possibly other autoimmune diseases.''
Robert P. Kimberly, M.D., Professor of Medicine and Microbiology, and Director, Division of Clinical Immunology and Rheumatology, The University of Alabama at Birmingham, said, ``Autoimmune diseases represent the third-greatest clinical burden after cardiovascular disease and cancer, and currently have no cure. These diseases are complex and often devastating chronic illnesses. Patients with systemic lupus, in particular, can experience any number of symptoms that can flare unexpectedly on average two to three times a year. For patients with severe symptoms, typically involving their internal organs, this disease can sometimes be fatal. There is great need for further research into the causes of these diseases, as well as for new treatment options that can help control disease progression and improve patients' quality of life.''
LymphoStat-B is a fully human monoclonal antibody that binds to and inactivates the BLyS protein. The drug was discovered in a collaboration between Human Genome Sciences and Cambridge Antibody Technology. The drug for clinical trials will be made in Human Genome Sciences' newly completed clinical trial manufacturing facility, located in Rockville, Maryland. Human Genome Sciences holds commercial rights to the drug.
Craig A. Rosen, Ph.D., Executive Vice President, Research and Development, Human Genome Sciences, Inc., said, ``LymphoStat-B represents a significant advance for patients with systemic lupus erythematosus. It is also our first compound to enter human clinical trials that is a monoclonal antibody. We now have the capacity to discover, optimize, manufacture and develop human monoclonal antibody drugs.''
He continued, ``To my knowledge, LymphoStat-B is also the first genomics-based antibody drug to enter clinical trials. LymphoStat-B binds to and inactivates the BLyS protein. BLyS was discovered by Human Genome Sciences using genomic methods. BLyS is currently being developed on its own as a drug to treat certain immune deficiency diseases.''(2)
David C. Stump, M.D., Senior Vice President, Drug Development, Human Genome Sciences, Inc., said, ``LymphoStat-B has the potential to treat a family of serious autoimmune diseases, including systemic lupus erythematosus and rheumatoid arthritis. If the initial Phase 1 trials of the drug are successful, we hope to be able to add new indications for additional trials for patients with rheumatoid arthritis and other autoimmune diseases, such as immune thrombocytopenic purpura, and Sjogren's syndrome. These studies should also shed much light on the role of hyperactive B-cell immunity, and of BLyS in particular, in the origin of a broad family of autoimmune diseases.''
William A. Haseltine, Ph.D., Chairman and Chief Executive Officer, Human Genome Sciences, Inc., said, ``I am delighted that we can now begin trials of LymphoStat-B for the treatment of systemic lupus erythematosus and other autoimmune diseases. As a family, these diseases cause immense suffering to millions of patients worldwide. LymphoStat-B provides a new, fresh, rational, mechanism-based approach for the treatment of these diseases.''
He added, ``LymphoStat-B also represents a significant milestone for our company. It is the sixth compound that we have entered into clinical trials. It is also our first antibody-based drug. As such, it demonstrates the powerful synergy achieved by combining genomic and antibody technology. I believe that this first genomics-based antibody drug represents a new era in medicine.'... |
