The Company also announced plans to initiate its third randomized chemotherapy combination trial of HGS-ETR1 by mid-2008 in patients with hepatocellular cancer, which accounts for 80-90% of all liver cancers. Preclinical data that support the hepatocellular cancer study were presented at the American Association for Cancer Research annual meeting in April.
Darapladib Advanced by GSK to Phase 3 Development as a Potential Treatment for Atherosclerosis
In its first quarter financial results press release on April 23, 2008, GSK announced that it intends to advance darapladib to Phase 3 clinical trials as a potential treatment for atherosclerosis and will shortly start discussions with regulators regarding the structure of the darapladib Phase 3 program.
At the American College of Cardiology's 57th Annual Scientific Session in March, GSK presented data from a randomized Phase 2 dose-ranging trial of darapladib in patients with coronary heart disease (CHD). The study showed that darapladib produced sustained, dose-dependent inhibition of plasma lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in patients receiving intensive atorvastatin (cholesterol-lowering) therapy. Lp-PLA2 is an enzyme associated with the formation of atherosclerotic plaques and identified in clinical trials as an independent risk factor for CHD and ischemic stroke. Changes in biomarkers suggested a possible reduction in systemic inflammatory burden. In addition, GSK stated in February 2008 that the results of its randomized Phase 2/3 imaging trial of darapladib in coronary artery disease have been submitted to a major medical journal.
Darapladib, a small-molecule inhibitor of Lp-PLA2, was discovered by
GSK based on HGS technology. HGS will receive a 10% royalty on worldwide
sales of darapladib if it is commercialized, and also has a co-promotion
option in North America and Europe under which it will pay 20% of
commercialization costs in exchange for 20% of dara
|SOURCE Human Genome Sciences, Inc.|
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