Research Shows Efforts To Quit Smoking Strengthen After Personalized Lung Cancer Risk Test

Studies On Respiragene^TM Test Presented To American Cancer Research Association Meeting

Smokers who see their own personal risk of developing lung cancer after genetic-based testing show stronger intention and take more action on quitting smoking, according to clinical trial results presented to an American Association of Cancer Research conference.

The pilot study looked at smokers' response to taking the Respiragene^TMtest, which combines genetic and non-genetic factors to show smokers and ex-smokers their own risk of lung cancer.

Lung cancer is the leading cancer killer in the United States, striking about one in 10 long-term smokers. An estimated 159,000 Americans will die of lung cancer in 2009, and around 219,000 Americans will be diagnosed with it. As with other smoking-related diseases, risk is sharply reduced by quitting smoking. But a recent report by U.S. Centers for Disease Control and Prevention said one in five Americans still smoke, and progress on stamping out smoking has stalled in the past five years.

Preliminary trial data presented at the AACR's "Frontiers in Cancer Prevention Research" conference now underway in Houston showed that smokers taking the Respiragene^TM test took increased and deliberate steps to try to quit soon after testing, with 56% of smokers showing greater intent to quit and 48% cutting down or stopping smoking, compared with peers who were also counseled but not tested.

The pilot study, conducted in Auckland, New Zealand, also showed that 40% actually made a quit attempt, compared to 12% among participants who were not tested. To date the study has recruited 50 smokers, and will be expanded. All were invited to enroll in a smoking cessation counseling and intervention program.

"The data suggests that a clinically meaningful predictive test can act as a powerful motivator for smokers," said Dr Robert Young, chief scientist with Synergenz Bioscience Ltd. Dr Young, who is also an Associate Professor in the Schools of Medicine and Biological Sciences at the University of Auckland, made the discoveries which led to development of the test.

"The test delivers smokers a personalized message that the risk of dying from lung cancer is actually theirs, not some other smoker's. Quitting is very difficult for most smokers, but success is greatest when individuals are highly motivated and offered support for smoking cessation, which should be the standard of care for all smokers," said Dr Young.

The Auckland study also found strong interest among smokers in taking the test (89% of those offered the Respiragene^TM test accepted); a generally positive response by smokers to the process (96% said they would recommend it to family and friends who smoke); and no evidence that individuals who received a Very High risk score (who are up to 10 times more likely to develop lung cancer than the average smoker) experienced counterproductive anxiety.

The study "The role of biomarkers of risk (Respiragene Test for lung cancer) and smoking cessation (Abstract #230)" also found that individuals receiving a "Moderate" score, placing them at approximately average smoker's risk for lung cancer, were not de-motivated from quitting.

In a second presentation to the conference, "SNP-SNP interaction and non-genetic risk factors combine to identify lung cancer susceptibility: validation in a prospective study (Abstract #255)," Dr Young reported on the results of a 10-year prospective trial in New Zealand that is tracking a group of 1212 smokers, consisting of 484 smokers with normal lung function, and 728 with Chronic Obstructive Pulmonary Disease (COPD), itself an indicator for lung cancer risk. Fifty two smokers have now developed lung cancer.

Among this group of 52 patients, 81% had a Very High or High risk score on Respiragene testing, consistent with earlier studies underpinning the test's ability to identify individuals at greatest lung cancer risk for targeted monitoring and intervention.

Dr Young's group also presented a review of the medical literature that examines the possible new role of the cholesterol-lowering drugs (statins) in reducing the risk of lung cancer. This presentation summarizes preliminary studies suggesting that people taking statins reduce inflammation in their lungs, lowering their risk of lung cancer. "Although quitting smoking remains the best way to reduce your risk of lung cancer, these findings suggest the anti-inflammatory effects of statins may also prove helpful," said Dr Young.

About Respiragene

The Respiragene test, taken via a mouth swab, combines a measurement of 20 genetic DNA mutations associated with the risk of developing lung cancer with non-genetic risk factors such as age, family history and diagnosis of COPD, to establish an individual's risk of developing lung cancer compared with other smokers.

Test results give each person a numerical score that corresponds with "Moderate", "High" or "Very High" risk categories. Those in the "Moderate" category have an approximate risk of developing lung cancer that is similar to that the average smoker. Those with "High Risk" scores are about four times more likely than an average smoker to get lung cancer; those in the "Very High Risk" category are about 10 times more likely to get lung cancer than the average smoker. Average smokers are 20 to 30 times more likely to develop lung cancer than non-smokers.

PHD Diagnostics and its clinical lab division, Molecular Diagnostics Laboratories, has licensed core technology for the Respiragene™ test from Synergenz, and developed the test specifically for the U.S. market in its CLIA-certified laboratory in Covington, KY. CLIA (Clinical Laboratory Improvement Amendments) is the national regulatory framework for medical laboratories. The test can be ordered by logging on to www.respiragene.com, sending an email to [e-mail] or calling MDL at 513-437-3000.

About Synergenz

Synergenz BioScience Ltd is a research leader in genomic tests for respiratory medicine. It was formed in 2004 to further advance discoveries first made by Dr. Robert Young at The University of Auckland in New Zealand, where studies continue in collaboration with leading researchers and the company's commercial partners around the world.

Frontiers in Cancer Prevention Research presentation titles:

• The role of biomarkers of risk (Respiragene Test for lung cancer) and smoking cessation (Abstract #230)
• SNP-SNP interaction and non-genetic risk factors combine to identify lung cancer susceptibility: validation in a prospective study (Abstract #255)
• The anti-inflammatory role of statins and lung cancer chemoprevention (Abstract # 226)

Contacts:

for Synergenz BioScience Ltd
In the US: Kenneth Li
[phone], ext 112;
[phone] (mobile)
[e-mail]
or
In Europe: Mary-Ellen Barker
[phone]
[e-mail]