HGSI’s Benlysta meets its endpoints in Bliss-52 phase III trial for lupus Earlier today, Human Genome Sciences, Inc. (HGSI) and GlaxoSmithKline PLC (GSK) announced that Benlysta met the primary endpoint in BLISS-52, the first of two pivotal phase III trials in patients with serologically active systemic lupus erythematosus (SLE). In the placebo-controlled BLISS-52 study, the results showed that Benlysta plus standard of care achieved a clinically and statistically significant improvement in patient response rate at Week 52 compared with standard of care alone. Study results also showed that Benlysta was generally well tolerated, with adverse event rates comparable between belimumab and placebo treatment groups. As a reminder, HGSI and GSK is co-developing Benlysta as a potential treatment for SLE. Benlysta is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator (BLyS). BLyS is a naturally occurring protein discovered ...

HGSI: NDA for Albuferon Expected to be Filed This FallWaiting for 2 Phase III Results for BenlystaNDA filing for Albuferon is expected in the fall for Hepatitis C      Albuferon is a novel long-acting form of interferon alpha. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers. Human Genome Sciences Inc. (HGSI) modified interferon alpha to improve its pharmacological properties by using its albumin fusion technology.HGSI has an exclusive worldwide agreement with Novartis (NVS) for the development and commercialization of Albuferon. The two companies are developing Albuferon as a potential treatment for chronic hepatitis C (HCV). Under this agreement, ...