SOUTH SAN FRANCISCO, Calif., March 19, 2012 /PRNewswire/ -- diaDexus, Inc. (OTC Bulletin Board: DDXS), a company focused on proprietary cardiovascular diagnostic products, today highlighted data from two recent studies evaluating the clinical utility of its PLAC® Test for Lp-PLA(2) Activity. The PLAC® Test for Lp-PLA(2) Activity is CE-marked for use outside of the United States and is an investigational assay in the United States. This test, which measures the pro-inflammatory enzymatic activity of Lp-PLA(2), was used to examine patient samples from two well-known clinical studies of statins, LIPID and JUPITER.
"The LIPID analyses indicate that a reduction in Lp-PLA(2) levels may impact coronary heart disease outcomes more than a reduction in LDL cholesterol in response to statin therapy. In fact, the LIPID trial found that the more you lower Lp-PLA(2), the more you reduce the risk of coronary heart disease. This is compelling because Lp-PLA(2) levels have not been measured this way in prior studies," commented Brian E. Ward, Ph.D., diaDexus Chief Executive Officer.
"The JUPITER trial demonstrated that Lp-PLA(2) levels are predictive of cardiovascular events in apparently healthy men and women. Additionally, JUPITER showed a positive trend between lower Lp-PLA(2) levels and cardiovascular outcomes as a response to statins. Taken together, the LIPID and JUPITER analyses performed by our PLAC® Test for Lp-PLA(2) Activity should be of great interest to physicians, their patients and advisory bodies, especially as they understand the differences in the two study populations," Dr. Ward added.
The LIPID study population was comprised of patients who had a prior history of myocardial infarction or hospitalization for unstable angina; the JUPITER study included healthy men and women with elevated levels of C-reactive protein, an inflammatory marker. The individuals enrolled in these studies had markedly different cholesterol levels. LIPID patients had high LDL cholesterol levels between 155 to 217 mg/dL while the JUPITER patients had lower LDL cholesterol levels of 130 mg/dL or less at time of enrollment.
LIPID Trial Conclusions*
- Reduction in Lp-PLA(2) is a significant predictor of coronary heart disease events.
- Change in Lp-PLA(2) may account for a substantial proportion of pravastatin (Pravachol®) effect in reducing coronary heart events.
- Higher baseline levels of Lp-PLA(2) activity significantly predict an increased risk of cardiovascular events including coronary heart disease death and myocardial infarction, similar total cardiovascular events and all-cause mortality but not in multivariate analysis, except for coronary heart disease death.
- Similar relative effects of pravastatin were observed within each subgroup defined by baseline Lp-PLA(2) quartiles (and with greater absolute benefit among those with higher baseline levels).
* DH White et.al., Circulation 124:A14857 (2011)
JUPITER Trial Conclusions**
- Among primary prevention patients allocated to the placebo, higher levels of Lp-PLA(2) activity were associated with increased cardiovascular risk.
- Among patients allocated to rosuvastatin (Crestor®), Lp-PLA(2) levels were not independently associated with residual cardiovascular risk. Treated patients with Lp-PLA(2) activity in the higher second, third and fourth quartiles had a somewhat greater relative risk reduction than did those with levels in the first quartile.
- Analysis with the Lp-PLA(2) turbidimetric mass assay did not yield significant results.
- (Note from diaDexus: The turbidimetric mass assay is not a commercial product.)
** PM Ridker et.al., Clinical Chemistry 58:5 (2012)
About the LIPID trial
The LIPID trial was a randomized controlled trial to determine the effects of cholesterol lowering on death from coronary heart disease among patients with coronary disease and average lipid levels. The trial was designed and initiated by Australian and New Zealand researchers including members of the Clinical Trials Research Unit of Auckland City Hospital, New Zealand. The trial involved 9014 patients, 3,056 of whom were recruited from New Zealand, and all of whom had a prior history of myocardial infarction or hospitalization for unstable angina. The study began in 1990 and was terminated at the end of 1997 (on the advice of the Data Monitoring Committee) as a result of evidence of a clear beneficial effect of pravastatin.
About the JUPITER trial
The JUPITER trial was a randomized, double-blind, placebo-controlled trial that investigated whether rosuvastatin 20 mg compared to placebo would decrease the rate of first major cardiovascular events. The trial enrolled 17,802 apparently healthy men and women with elevated levels of C-reactive protein. The trial was conducted by investigators in 26 countries and overseen by an academic statistician (Robert Glynn, PhD, Harvard University, USA) and an independent Data and Safety Monitoring Board (chaired by Professor Rory Collins, Oxford University, UK). The study was funded by AstraZeneca, US who had no access to unblinded trial data and played no role in analysis or interpretation of the study data or in manuscript preparation. Dr. Ridker, the JUPITER principal investigator, is listed as a co-inventor on patents held by Brigham and Women's Hospital that relate to the use of inflammatory biomarkers in cardiovascular disease that have been licensed to AstraZeneca.
About diaDexus, Inc.
diaDexus, Inc., based in South San Francisco, California, is focused on the development and commercialization of patent-protected in vitro 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 CHD and ischemic stroke associated with atherosclerosis, the #1 and #3 causes of death, respectively, in the United States. For more information, please visit the company's website at www.diaDexus.com. The company's PLAC Test for Lp-PLA(2) Activity has received CE marking in the European Union to aid in predicting risk for CHD.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the company's plans, objectives, expectations and intentions with respect to future financial results, operations and products and other statements that are not historical in nature, particularly those that use terminology such as "will," "potential", "could," "can," "believe," "intends," "continue," "plans," "expects," "estimates" or comparable terminology. Forward-looking statements are based on current expectations and assumptions, and entail various known and unknown 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 diaDexus' ability to submit a new 510(k) application for, and obtain FDA clearance of, its new automated Lp-PLA(2) Activity test; diaDexus' ability to gain acceptance of its PLAC® Test products in the marketplace, including its ability to demonstrate that treatment of individuals based on their Lp-PLA(2) levels improves clinical outcomes in prospective clinical studies; diaDexus' high degree of customer concentration, including the downward pressure that its largest customers may be able to exert on its product pricing; diaDexus' relationship with key customers, including GlaxoSmithKline, the licensor of Lp-PLA(2); diaDexus' reliance on a sole source third party manufacturer to manufacture and supply diaDexus' PLAC® ELISA Test; third party payors' acceptance of and reimbursement for the PLAC® Test; diaDexus' ability to develop and commercialize new products and services; various risks associated with the international expansion of diaDexus' business; diaDexus' ability to successfully launch and commercialize the PLAC® Test for Lp-PLA(2) Activity in Europe, and its dependence on its distributors for foreign sales of that test; diaDexus' ability to initiate and continue to manufacture the PLAC® Test for Lp-PLA(2) Activity at its facility in South San Francisco, California; the adequacy of diaDexus' intellectual property rights; diaDexus' ability to satisfy its obligations under its license agreements, to maintain its license rights under those license agreements and to enter into any necessary licenses on acceptable terms; diaDexus' ability to attract, retain and motivate qualified personnel; the effects of U.S. and foreign government regulations and diaDexus' ability to comply with such regulations; diaDexus' limited revenue and cash resources; and diaDexus' significant corporate expenses, including real estate lease liabilities and expenses associated with being a public company. 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 annual report on Form 10-K and subsequent quarterly reports 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 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.
SOURCE diaDexus, Inc.