Stratifying the study according to KIF6 status demonstrated increased effectiveness of statin therapy in KIF6 carriers: the number needed to treat to prevent one CHD event was 16 in carriers compared with 83 in noncarriers.

KIF6 has been associated with differential reduction of coronary events from statin therapy in 4 prospective randomized double blind clinical trials and with risk of coronary events in 5 prospective cohorts.

ALAMEDA, CA - March 24, 2010 - Celera Corporation (NASDAQ:CRA), today announced the publication of data reporting that elderly (over age 70) carriers of the KIF6 gene variant with prior vascular disease received significant benefit from pravastatin (Pravachol®) therapy. Previous research has shown that a variant of the KIF6 gene, a member of the molecular motor protein kinesin family, is associated with up to a 55% increased risk of primary and recurrent coronary heart disease (CHD) events in the placebo arms of the clinical trials, and that this increased risk is virtually eliminated with statin therapy. This paper has been published ahead of print in the European Journal of Cardiovascular Prevention and Rehabilitation, and is currently available on the publication’s website at:

http://journals.lww.com/ejcpr/Abstract/publishahead/KIF6_Trp719Arg_polymorphism_and_the_effect_of.99827.aspx

The effect of pravastatin versus placebo on coronary events according to KIF6 carrier status was investigated among 5,752 patients of the PROspective Study of Pravastatin in the Elderly at Risk (PROSPER) study. A key finding of the study was that in 2,542 subjects with prior vascular disease, pravastatin therapy significantly reduced coronary events in KIF6 carriers but not in noncarriers: absolute risk reduction was 6.3% in carriers versus 1.2% in noncarriers. The study showed that the number needed to treat (NNT) with pravastatin to prevent one CHD event was 16 in KIF6 carriers and 83 in noncarriers. The original reports of the PROSPER study indicated that only the elderly with prior vascular disease received substantial and significant reduction of events from pravastatin therapy. The differential reduction of CHD events between KIF6 carriers and noncarriers in PROSPER patients with prior vascular disease was observed despite the same on-therapy lipid levels observed in carriers and noncarriers.

"We're pleased to have replicated our findings for KIF6 in this important segment of the population as it provides additional information to help physicians identify those elderly patients with prior vascular disease in whom statins work particularly well," said Kathy Ordoņez, Chief Executive Officer of Celera

Celera is pursuing regulatory registration for a diagnostic product based on research findings pertaining to KIF6.

End point
The end point of this genetic study of PROSPER was time from enrollment to the first incident coronary event, a composite of coronary heart disease death, nonfatal myocardial infarction, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft. This genetic study was able to evaluate 5,752 of the 5,804 patients enrolled in PROSPER.

Other research on KIF6
The KIF6 associations have been demonstrated previously in two prospective, randomized clinical trials that assessed the effect of pravastatin on the prevention of CHD events: the secondary prevention Cholesterol and Recurrent Events (CARE) study and the primary prevention West of Scotland Coronary Prevention Study (WOSCOPS). Additionally, a genetic study of PROVE IT-TIMI 22 reported that in patients after an acute coronary syndrome (ACS), high-dose atorvastatin (Lipitor®), compared with standard dose pravastatin, was significantly more effective at reducing CHD events in KIF6 carriers than in noncarriers.

The KIF6 gene variant was previously reported to predict risk of CHD in other prospective studies. This gene variant was associated with increased risk of CHD in Caucasian and African American participants of the Atherosclerosis Risk in Communities (ARIC) study (a study of 12,556 middle aged Americans), and with increased risk for myocardial infarction (MI) in both the Cardiovascular Health Study (a study of 4,552 Americans, aged 65 or older), and the Women’s Health Study (a study of 25,283 women older than 45 years without a previous history of CHD). Thus, this KIF6 gene variant has been associated with CHD risk in studies including a total of approximately 55,000 people.

The increased risk of CHD events observed in KIF6 carriers has been shown to be independent of other well-known CHD risk factors, including smoking, hypertension, cholesterol level, age and sex, further supporting the conclusion that the KIF6 gene variant is an independent predictor of risk for CHD. To date, the benefit of statin therapy for KIF6 carriers has only been studied with atorvastatin and pravastatin therapy.

In a case-control analysis of subjects in the Ottawa Heart Study, no association was found between KIF6 and arteriographic evidence for a >50% coronary artery narrowing, which is a different clinical endpoint than the CHD examined in the other KIF6 studies referenced above. In this study, 89% of the cases were on statin therapy, which Celera believes may have had an effect on the lack of an association with risk in KIF6 carriers.

About the PROSPER study
The study population was derived from PROSPER, a randomized, double-blind, placebo-controlled trial designed to assess the effect of pravastatin for the prevention of major cardiovascular events among participants aged at least 70 years at enrollment who were at risk for cardiovascular events because of preexisting vascular disease, smoking, hypertension, or diabetes. 5,804 patients (2,804 men and 3,000 women) were randomized to treatment with 40 mg pravastatin per day or placebo in three centers (Cork, Ireland; Glasgow, Scotland; and Leiden,The Netherlands) and followed for an average of 3.2 years; 44.2% of the enrolled patients had a history of prior vascular disease (myocardial infarction, stable angina, intermittent claudication, stroke, transient ischemic attacks, arterial surgery, or amputation for vascular disease more than 6 months before study entry).

The PROSPER study was led by Professors James Shepherd and Ian Ford at the University of Glasgow and Royal Infirmary, Glasgow, United Kingdom; Professor Wouter Jukema from University of Leiden, The Netherlands; and Professor Michael Murphy University College Cork, Ireland. Olga A. Iakoubova, M.D., Ph.D., Principal Investigator at Celera, was the lead author of this genetic study which was conducted with collaborators at the University of Glasgow and Royal Infirmary, Glasgow, UK, Leiden University Medical Center, Leiden, The Netherlands, and University College Cork, Ireland. All statistical analysis was performed by the statistical group at the University of Glasgow.

The full press release can be found on the Celera website at: https://www.celera.com/celera/pr_1269391715

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