NEW YORK, Nov. 1 — Human Genome Sciences on Thursday announced that a monoclonal antibody product it developed has been approved by the US Food and Drug Administration to begin phase I trials, becoming the first drug candidate of its kind identified through genomics techniques to reach this stage.
The product, LymphoStat-B, will first be tested as a treatment for the autoimmune disease lupus. Clinical trials should begin by the new year, said company spokesperson Jerry Parrot.
LymphoStat-B binds to and inactivates B lymphocyte stimulator, a protein that HGS identified in collaboration with Cambridge Antibody Technology of Melbourn, England. An immune system stimulant, that protein may be involved in a number of cancers and autoimmune disorders. According to the company, patients with lupus and rheumatoid arthritis often have elevated blood levels of the protein.
The two firms, which have a 10-year research partnership, discovered the protein by screening HGS’s database for substances that stimulate B cell growth.
HGS, based in Rockville, Md., is also studying the protein for treatment of various endogenous and acquired immune system disorders, infectious diseases, and certain cancers.
The company currently has two other products in phase II trials, also identified and developed through genomics research. HGS coordinates these trials, which are carried out in partnership with academic institutions.
Lupus is a chronic disease that causes debilitating joint pain, fatigue, and can lead to circulatory, nervous system, and kidney disorders. Between 200,000 and 500,000 people, primarily women, are diagnosed with the disease in the United States each year.
HGS is currently conducting trials on four other compounds.