Brigham and Women's Hospital and Celera Publish Results Demonstrating That Carrriers of a Variant of the LPA Gene Have More Than Two-Fold Higher Risk of Major Cardiovascular Events and That This is Eliminated by Aspirin Therapy
Alameda, CA - September 09, 2008
Celera Corporation (NASDAQ:CRA) and its collaborators at Brigham and Women’s Hospital today announced the publication of a paper reporting that a variant of the LPA gene is associated with a two-fold higher risk of major cardiovascular events (myocardial infarction, ischemic stroke and cardiovascular death). Prior studies from Celera and other collaborators also reported the association of this gene variant and cardiovascular risk. The newly published study confirmed the increased risk associated with this LPA variant and showed that the excess risk was eliminated by taking low dose aspirin. The paper is currently available on the journal’s website at http://www.atherosclerosis-journal.com/article/S0021-9150(08)00522-4/abstract.
These findings were based on analysis of 25,131 participants in the Women’s Health Study (WHS), a randomized trial of aspirin and placebo in the primary prevention of cardiovascular disease conducted among initially healthy women aged at least 45 at enrollment, who were followed over a 10 year period for major cardiovascular events. Approximately 4% of the participants in the WHS were carriers of the LPA gene variant. In the placebo arm of this study, these carriers had a more than two-fold increased risk of major cardiovascular events compared with noncarriers. In the group taking low dose aspirin, there was no difference in the risk of major cardiovascular events between carriers and non-carriers of the LPA gene variant, suggesting that women who are carriers of the risk variant of the LPA gene can mitigate their excess risk for cardiovascular disease by taking low dose aspirin.
The benefit of aspirin therapy among carriers of the gene variant could be observed soon after the start of the study, was consistent throughout the study, and increased over time. The reduction of risk for major cardiovascular events among carriers would have resulted in a number-needed-to-treat (NNT) to prevent one major cardiovascular event of 37 for carriers compared with 625 for non-carriers, with no difference in the rate of major bleeding events.
The increased risk of cardiovascular events observed in LPA carriers and its reduction by aspirin therapy was independent of other well known CHD risk factors including hypertension, LDL-cholesterol, HDL-Cholesterol, and age, which further supports the conclusion that a LPA gene variant is a new, independent predictor of risk for CHD and clinical benefit from aspirin therapy. LPA encodes apolipoprotein(a) a protein component of Lp(a) plasma lipoprotein particles and the gene variant results in an amino acid substitution (methionine for isoleucine) in the protease-like domain of apolipoprotein(a). Carriers of the LPA gene variant also had higher plasma Lp(a) levels.
“This study indicates that carriers of the LPA gene variant are both at higher risk of cardiovascular disease and that this risk is reduced by aspirin therapy,” said Daniel Chasman, Ph.D., Assistant Professor of Medicine at Brigham and Women’s Hospital and Harvard Medical, Boston, MA, and the lead author of the paper. “The publication of these data should motivate further studies that explore the biological role of LPA in the development of cardiac events.”
“If found to be a consistent effect in other patient populations, these data could provide a genetic method for defining subpopulations with differential benefit from aspirin therapy, an issue pertinent to the controversial choice of aspirin or aspirin alternatives in the prevention and treatment of vascular disease,” added Professor Paul Ridker, M.D., Director of the Center for Cardiovascular Disease Prevention, Division of Cardiology, at Brigham and Women’s Hospital and Harvard Medical School, Boston, MA the senior author of the paper.
“These findings make a compelling case for testing for LPA status,” said Thomas White, Ph.D., Chief Scientific Officer at Celera. “Moreover, an increasing number of gene variants that predict risk for disease also prove to predict drug response, making the case that risk variants should be tested in clinical trials to provide greater insight into the balance between risk and drug efficacy.”
Berkeley HeartLab, a subsidiary of Celera, is expected to offer a laboratory-developed test for the LPA gene variant. Celera plans to pursue regulatory registration for a diagnostic product based on this research and other findings.
“The LPA gene variant test planned to be introduced at Berkeley Heart Lab is based on Celera's consistently replicated discoveries as reported in multiple publications. Testing for the LPA variant is expected to be an important addition to our expanding menu of tests focused on personalizing cardiovascular disease management.” said Kathy Ordoñez, Chief Executive Officer of Celera.
Celera is a healthcare business delivering personalized disease management through a combination of products and services incorporating proprietary discoveries. Berkeley HeartLab, a subsidiary of Celera, offers services to predict cardiovascular disease risk and improve patient management. Celera also commercializes a wide range of molecular diagnostic products through its strategic alliance with Abbott and has licensed other relevant diagnostic technologies developed to provide personalized disease management in cancer and liver diseases. Information about Celera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available at http://www.celera.com.
Certain statements in this press release are forward-looking. These may be identified by the use of forward-looking words or phrases such as "believe," "plan," and "should," among others. These forward-looking statements are based on Celera Corporation's current expectations. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for such forward-looking statements. In order to comply with the terms of the safe harbor, Celera notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These factors include but are not limited to: (1) Celera is using novel and unproven methods to discover markers for the development of new diagnostic products, which may not be successful; (2) the diagnostic industry is very competitive, and new diagnostic products may not be accepted and adopted by the market; (3) demand for diagnostic products may be adversely affected if users of these products cannot receive adequate reimbursement for these products from third party payors such as private insurance companies and government insurance plans; (4) intense competition in the industries in which Celera operate; (5) potential product liability or other claims against Celera as a result of the testing or use of its products; (6) uncertainty of the availability to Celera of intellectual property protection, limitations on its ability to protect trade secrets, the risk to it of infringement claims, and the possibility that it may need to license intellectual property from third parties to avoid or settle such claims; and (7) other factors that might be described from time to time in Celera's filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Celera does not undertake any duty to update this information, including any forward-looking statements, unless required by law.
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