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DDXS > SEC Filings for DDXS > Form 8-K on 12-Nov-2013All Recent SEC Filings

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Form 8-K for DIADEXUS, INC.


12-Nov-2013

Other Events, Financial Statements and Exhibits


Item 8.01. Other Events.

On November 12, 2013, diaDexus, Inc. (the "Company") issued a press release reporting on topline lipoprotein-associated phospholipase A2 ("Lp-PLA2") inhibitor Phase 3 clinical data from the STABILITY trial reported by GlaxoSmithKline plc ("GSK"). The announcement specified that GSK's Lp-PLA2 inhibitor, darapladib, did not meet its primary endpoint measure, which was time to first occurrence of any major adverse cardiovascular event.

GSK has indicated that patient sub-group analyses of the STABILITY trial will be forthcoming. The Company's patent protected research use only activity assay was used by GSK in the study to measure patient Lp-PLA2 activity at baseline and during follow-up visits. Lp-PLA2 levels aid in cardiovascular disease ("CVD") risk assessment independent from other biomarkers-providing insight into the relationship between inflammation, atherosclerosis and CVD outcomes. GSK stated that it will continue investigating the role of Lp-PLA2 inhibition in connection with further analysis of the data from the STABILITY trial, including evaluation of the patient sub-groups. GSK indicated that further results from a second Phase 3 study of darapladib in acute coronary syndrome, designated as SOLID-TIMI 52, are expected to be available in 2014.



Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit
  No.                                     Description

99.1         Press release entitled "diaDexus, Inc. Provides Update Related to
             Topline Lp-PLA2 Inhibitor Data Reported by GlaxoSmithKline" issued by
             diaDexus, Inc. on November 12, 2013.


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