WASHINGTON D.C. – March 21, 2012, San Diego, California – FirstMark today announced further results from the completed clinical study for the multiple biomarker cardiovascular blood test PREvent. This follows the February 16, 2012 press release announcing the completion of the clinical study demonstrating the extraordinary effectiveness of the test to predict risk of near-term (2-3 years) myocardial infarction, and death in patients with suspected or confirmed, insignificant or significant stable CAD. The clinical study and data was well received in an oral presentation, Beyond Courage: A Possible Strategy for Identifying the Stable CAD Patient at High Risk of MI or Death, by Dr. Stephen E. Epstein, Executive Director of the Cardiovascular Research Institute, MedStar Health Research Institute, at Cardiology Grand Rounds, Washington Hospital Center, Washington D.C. on March 20, 2012.
The study revealed superior cardiac risk information by identifying the top 5% of CAD patients at the highest risk of MI with a hazard ratio of 5.5. The data showed an annual average of 18.2% of significant CAD patients with all three biomarkers elevated experienced a myocardial infarction or death, compared to only 2.45% of significant CAD patients with all biomarkers normal. The multiple biomarker model adds markedly to traditional risk-prediction by significantly improving C-statistics from 0.695 for base model to 0.750, distinguishing high risk from low risk subjects.
The initial results are reinforced by the additional findings, indicating very poor correlations between the levels of the test’s individual biomarkers, suggesting that they are mainly independent of each other. The findings further indicate that the ability to risk strategize may improve by aggregating the results. Investigators found that regardless of whether patients were previously established into low, intermediate, or high risk clinical groups, the data from the aggregate biomarkers were able to further distinguish low and high risk patients.
“The data continues to show the test to be substantially greater than alternative markers of risk. Its ability to further distinguish patients according to specific clinical groups is beyond encouraging,” said Thomas Silberg, President and CEO of GenWay Biotech. “PREvent is a simple and inexpensive, powerful predictor of risk supported by distinguished cardiologist. The critical data and support from cardiologists shows a clear-cut clinical need for PREvent, not only for healthcare cost savings, but most importantly, saving lives through earlier detection.”
About the Study
The study was based on long-term research that reveals that there are multiple factors involving components of inflammatory, thrombotic, infectious, and autoimmune pathways that contribute to the development of CAD, subsequent plaque rupture, and adverse outcomes. The research interrogated these pathways both separately and combined, utilizing HSP70, HSP60, hsCRP, FDP levels and seropositivity to CMV biomarkers. The biomarker panel was narrowed down to three markers that provide most valuable information to include hsCRP, FDP, and HSP70. A bioanalytic statistical ranking model (the Aggregate Pathway Risk) was developed that best predicts existing CAD as well as imminent MI. Of note, the investigators found poor correlations between the levels of each of the biomarkers. This suggested, as was originally hoped by the investigators, that these biomarkers are mainly independent of each other, a finding further suggesting that by aggregating the results, the ability to risk strategize may improve. The results were confirmatory of this.
The controlled study included blood samples from 3,800 patients admitted for cardiac catheterization. The individuals were documented from angiograms for the presence and severity of coronary artery disease. The study design included four groups of patients angiographically confirmed with insignificant or significant CAD, with MI or death and without MI or death. Each group was followed for a minimum of 1 year and a mean of 2.75 years. Groups were matched for age, gender, and cardiovascular risk factors using propensity scoring. Of further interest, the investigators grouped patients, by clinical risk factors (age >65, diabetes, smoking history, LVEF <45%, AMI on presentation, and coronary stenosis =50%). They found that regardless of whether patients were in the low, intermediate, or high risk clinical groups, the biomarkers were able to further distinguish low and high risk patients within each of the clinical risk groups. For example, in the high risk clinical group patients with no biomarker positive had a 4 year event-free survival of about 75%, whereas the event-free survival fell to nearly 40% in those patients with =2 biomarkers positive.
Additional study details are provided at: firstmarkprevent.com
FirstMark is a division of GenWay Biotech, Inc. The FirstMark division is focused on the development and commercialization of non-invasive diagnostic and health monitoring tests for unmet clinical needs. Headquarters are located in the heart of San Diego’s biotech community in the Sorrento Valley/Mesa area. For additional information please visit FirstMarkPREvent.com.