sphingotec at the St. Gallen International Breast Cancer Conference

Biotech company to present how biomarkers improve breast cancer risk prediction in women under hormone replacement therapy. Cambridge, Mass. – Feb. 4, 2015 – sphingotec LLC announced today that the findings from its research seeking to improve breast cancer risk stratification for guiding hormone replacement therapy has been selected for presentation at the 14th annual St. Gallen International Breast Cancer Conference in Vienna, Austria, March 18 – 21, 2015. The poster will be presented by Dr. Uwe Hantke.

sphingotec’s study assessed how plasma pro-­neurotensin (pro-­NT) and pro-­enkephalin (pro-­ENK) help predict whether women have high or low risk for developing breast cancer so physicians can make a more informed decision on whether to use hormone replacement therapy. The results concluded that both plasma pro-­NT and pro-­ENK provide new and independent information above and beyond commonly known breast cancer risk factors that can improve risk stratification.

As further evidence of the power of pro-­NT and pro-­ENK risk prediction, a theoretical model demonstrated that 10 out of 123 breast cancer occurrences could have potentially been avoided if clinicians knew their patients’ pro-­NT and pro-­ENK levels put them in an extremely high-­risk group and used this information to avoid HRT.

Although extensive research has been conducted around the risks and benefits of HRT there is disagreement on whether the benefits outweigh the risks. According to The Centers for Disease Control and Prevention (CDC), those who caution against using HRT often refer to the increased risk of endometrial and breast cancer associated with using estrogen, especially for extended lengths of time. Those who advocate for its use often point out that HRT appears to reduce the risk of osteoporosis, heart disease and Alzheimer’s disease in addition to alleviating menopausal symptoms. The controversy surrounding HRT leaves clinicians and their patients feeling uncertain about individual breast cancer risk, one of the most common types of cancer for women.

“Studies have shown that hormone replacement therapy can increase the risk of breast cancer, but it varies greatly based on each woman’s individual characteristics and risk factors,” said Dr. Andreas Bergmann, CEO of SphingoTec GmbH. “There is a huge unmet need for improved risk stratification to help doctors decide whether to recommend hormone replacement therapy. We believe our research will enable doctors and their patients to make a more educated decision on whether this treatment is right for them.”

To conduct the study, sphingotec researchers measured pro-­ENK and pro-­NT in fasting plasma from 1,929 women participating in the Malmö Diet and Cancer Study and used Cox proportional hazards models to relate pro-­ENK and pro-­NT to first breast cancer events within 15 years of follow up. For the cohort design, they sampled 1,569 women from the Malmö Preventive Project and used multivariate adjusted logistic regression models to relate pro-­ENK and pro-­NT to first breast cancer events during the observation period. They then analyzed subgroups of women who received HRT to assess the performance of each marker.

This study supports sphingotec’s mission to reduce the incidence of major illnesses such as cancer, cardiovascular conditions and kidney disease through tests that can detect individual risk factors. sphingotec has developed two simple blood tests, sphingotest® pro-­NT and the sphingotest® pro-­ENK that identifies the concentration of these peptides in the blood. The biomarkers are independently associated with the development of breast cancer above other commonly known risk factors and are applicable to all females, regardless of genetic predispositions. Both pro-neurotensin and pro-­enkephalin assays will be available to the U.S. and European markets later this year.

sphingotec also announced today that the breast cancer biomarkers pro-­NT and pro-­ENK will be featured in a mid-­morning session at the American Association of Clinical Chemistry (AACC) Annual Meeting & Clinical Lab Expo in Atlanta, Georgia July 26 – 30, 2015. A panel of leading researchers will address the gaps and limitations in breast cancer prevention programs and how emerging biomarkers can help clinicians and laboratorians address the key challenges. The panelists are:

Dr. Max Wicha, distinguished professor of oncology and director of the Comprehensive Cancer Center at University of Michigan

Dr. Allan Jaffe, M.D., Mayo Clinic cardiologist and division chair, Clinical Core Laboratory Services

Dr. Alan Maisel, director of the Coronary Care Unit and Heart Failure Program at the VA San Diego Healthcare System, Professor of medicine at University of California, San Diego

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