SOUTH SAN FRANCISCO, Calif.--(EON: Enhanced Online News)--diaDexus, Inc. (OTCQB:DDXS) highlighted today the published observation that a reduction in Lp-PLA2 (lipoprotein-associated phospholipase A2) levels while on a statin treatment can reduce coronary heart disease (CHD) risk. Earlier this month, the Journal of the American Heart Association published the results from a sub-study on the Long-term Intervention with Pravastatin in Ischemic Disease (LIPID) study of pravastatin in CHD patients.
“There was a 24 percent (P<0.001) reduction in death from CHD and a 22 percent (P<0.001) reduction in overall mortality observed in this study. These results elevate Lp-PLA2 to that of a risk factor for CHD.”
The sub-study showed that patients who had the biggest drop in Lp-PLA2 activity levels on pravastatin therapy were most likely to have the greatest benefit, with fewer CHD deaths and heart attacks, as well as significantly fewer total cardiovascular disease events (p<0.001). The majority of the treatment effect (59 percent) was accounted for by changes in Lp-PLA2 activity, and the authors concluded that this reduction was at least as important as LDL cholesterol (LDL-C) reduction in predicting a favorable response to pravastatin treatment.
“It is well understood that reduction in LDL-C is a key mechanism by which statins reduce risk. This study proves that other mechanisms are also important—reduction in Lp-PLA2 activity during the first year may account for more than half of the benefits of pravastatin in the LIPID Study,” said Harvey White, DSc, the lead investigator on the study and cardiologist at Auckland City Hospital Green Lane Cardiac Service. “There was a 24 percent (P<0.001) reduction in death from CHD and a 22 percent (P<0.001) reduction in overall mortality observed in this study. These results elevate Lp-PLA2 to that of a risk factor for CHD.”
“This is one of the first outcome studies to support the value of measuring and lowering Lp-PLA2 activity to help prevent coronary events,” said Brian Ward, Ph.D., diaDexus’ president and chief executive officer. “The LIPID study used the diaDexus research use only activity assay, which is now a CE marked test, and we anticipate that we will submit the assay for clearance to the FDA.”
About the LIPID Study
The LIPID study (Long-term Intervention with Pravastatin in Ischemic Disease) was funded by Bristol-Myers Squibb and conducted by the National Heart Foundation of Australia. The sub-study was supported by the National Health and Medical Research Council of Australia and diaDexus.
LIPID was a large (n=9014), double-blind, placebo-controlled study of pravastatin in CHD patients. During a mean 6.0-year follow-up, there were significant reductions in the primary end point of death from CHD, all-cause mortality, and other pre specified cardiovascular end points, including the composite of nonfatal myocardial or CHD death.
About diaDexus, Inc.
diaDexus, Inc., based in South San Francisco, California, develops and commercializes proprietary cardiovascular diagnostic products addressing unmet needs in cardiovascular disease. The company's PLAC® Test ELISA Kit is the only blood test cleared by the FDA to aid in predicting risk for both coronary heart disease and ischemic stroke associated with atherosclerosis, the #1 and #3 causes of death, respectively, in the United States. The company's PLAC® Test for Lp-PLA2 Activity, a CE-marked test, is an indicator of atherosclerotic cardiovascular disease, the #1 cause of death in Europe. diaDexus is ISO 13485 certified and manufactures the PLAC Test for Lp-PLA2 Activity on-site. For more information, please visit the company's website at www.diaDexus.com.
This release contains forward-looking statements based on current expectations and assumptions and entail various risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements. Important factors known to diaDexus that could cause actual results to differ materially from those expressed in such forward-looking statements include whether future studies may support the scientific results observed in the LIPID study; the timing of the submission of the PLAC Test for Lp-PLA2 Activity and whether, following submission, it can achieve FDA clearance and if even if cleared, the ability to gain acceptance in the marketplace; and the timing of data from a longitudinal cardiovascular disease study necessary to support submission for clearance to the FDA. Additional factors that could cause diaDexus' results to differ materially from those described in the forward-looking statements can be found in diaDexus' most recent quarterly report on Form 10-Q and other reports filed with the Securities and Exchange Commission, and available at the SEC's web site at www.sec.gov. The information set forth herein speaks only as of the date hereof, and except as required by law, diaDexus disclaims any intention and does not assume any obligation to update or revise any forward looking statement, whether as a result of new information, future events or otherwise.