LymphoStat-B(R): Completion of Phase 3 Enrollment Expected by Fall 2008
In November 2007, Phase 2 results through 2.5 years of LymphoStat-B treatment were presented at the annual meeting of the American College of Rheumatology. Based on these results, HGS believes that LymphoStat-B (belimumab) could be a breakthrough treatment for systemic lupus erythematosus (SLE), assuming success in Phase 3. LymphoStat-B is being developed by HGS and GSK under a co-development and commercialization agreement entered into in August 2006.
Enrollment is progressing well in the pivotal Phase 3 trials of LymphoStat-B in patients with active SLE. HGS expects to complete enrollment of BLISS-76 and BLISS-52 by fall 2008, with Phase 3 data from both trials expected in 2009.
ABthrax(TM): Manufacturing on Schedule to Begin Delivery Fall 2008
HGS reported in December 2007 that it has demonstrated a statistically significant survival benefit for ABthrax (raxibacumab) in the treatment of inhalation anthrax in two animal species, which is the requirement for establishing the efficacy of new drugs used to counter bioterrorism. ABthrax is being developed under a $165 million contract with the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS). HGS has reached agreement with the FDA on the regulatory pathway for ABthrax and plans to submit the final data package to BARDA and FDA by mid-2008 to support authorization of delivery to the Strategic National Stockpile. The Company is currently manufacturing ABthrax on schedule to begin delivery of 20,000 doses to the Stockpile by fall 2008.
Oncology Products: IAP Inhibitors Offer New Opportunities; Data from
HGS- ETR1 Ph
|SOURCE Human Genome Sciences, Inc.|
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