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Quintiles’ Study Offers View of How Pre-screening for Personalized Cancer Treatments Would Work

How do you match up the appropriate patient with the right drug and implement treatment rapidly? That is a question at the heart of personalized medicine and the focus of a study by Quintiles to develop best practice.

In a study of patients with colorectal cancer, it’s investigating how pre-profiling and genomic sequencing data, including the number of genetic changes that occur, could support physician treatment decisions, including the identification of appropriate clinical trials for patients. The Feasibility study of Biomarker Analysis for Patients with Metastatic Colorectal Cancer is expected to go on for 10 weeks. US Oncology Research is participating in the study and it’s supported by McKesson Specialty Health and the US Oncology Network.

The tumor analysis and assessing the bioanalytic requirements is done in Quintiles labs in Durham, North Carolina. Those observations and assessments are being packaged into a report for physicians.

In a phone interview with Quintiles Chief Medical and Science Officer Jeffrey Spaeder, he said: “Instead of looking at just one biomarker and method of action and determining if the patient is appropriate for inclusion in a study, we are looking at a much larger number of genomic variants and allowing the healthcare provider and patient to make more informed decisions about [which treatment to go forward with.”

It’s about matching FDA-approved therapies, as well as therapies in development that have a specific benefit-risk profile for specific patient populations. Instead of bench to bedside, it’s more like bedside to bench and back again.

Spaeder said: “We have the capabilities to do this appropriately and think it is a new way of providing information to the treatment of patients and clinical research.”

Many groups see the benefit of personalized medicine since, based on our genetic makeup, two people with the same condition are likely to respond better to one treatment than another. But one of the challenges has been how to implement that approach. The Quintiles study represents an important piece of that puzzle.

Source: MedCity News

NICE Recommends Genomic Health’s Oncotype DX® Test To Guide Chemotherapy Treatment Decisions For Qualified Early-Stage Invasive Breast Cancer Patients

Genomic Health, Inc. recently announced that the National Institute for Health and Care Excellence (NICE) in the United Kingdom has issued its final guidance recommending Oncotype DX® as the only multi-gene breast cancer test for use in clinical practice to guide chemotherapy treatment decisions for patients with early-stage, hormone receptor-positive, invasive breast cancer. Consistent with leading international breast cancer treatment guidelines, including ASCO®, NCCN®, ESMO® and St. Gallen, NICE’s recommendation recognizes the unparalleled evidence of the clinical validity of the Oncotype DX test and its ability to enable physicians and their patients to make more informed, individualized decisions.

“It is encouraging to see growing recognition of the value of genomic testing. Its provision has enhanced the care of breast cancer patients around the world and it will now be available as an option in the UK,” said David Miles, M.D., medical oncologist at Mount Vernon Cancer Centre, Northwood, Middlesex, United Kingdom. “NICE’s recommendation for the use of Oncotype DX in the UK is an important step forward, enabling physicians and patients to make better-informed treatment decisions based on the biology of an individual patient’s breast cancer.”

To date, more than 1,500 women in the UK have utilized the Oncotype DX test to help guide their treatment decisions. Breast cancer is the most commonly diagnosed cancer in women, with almost 50,000 people diagnosed each year in the UK. Most of these patients are diagnosed with early-stage, invasive breast cancer and a significant number of them could benefit from this test under the NICE recommendation.

“The decision of whether or not to undergo chemotherapy is an extremely important and difficult one for patients, not only due to the many side effects associated with treatment, but also due to the hardship for the patient and her family and the loss of income due to days off work. Allowing patients and their physicians to make more personalized treatment decisions can help improve outcomes for the rising number of early-stage breast cancer patients in Europe,” said Kathi Apostolidis, vice president, European Cancer Patient Coalition, Brussels, Belgium, and a two-time breast cancer survivor, commenting on the NICE announcement. “We hope NICE’s decision will also inspire other European countries to provide broader access to novel diagnostics such as Oncotype DX, which allows informed decision making for sparing the burden of chemotherapy from those who do not need it.”

With data showing that only four out of 100 early-stage invasive breast cancer patients benefit from chemotherapy, the Oncotype DX test helps improve patient outcomes by personalizing treatment decisions through assessment of the risk of cancer recurrence and chemotherapy benefit.

“Given NICE’s rigorous review process and its influence throughout the region, we believe this decision brings us an important step closer to achieving our mission to improve the quality of treatment decisions for cancer patients across Europe and around the world,” said Steven Shak, M.D., executive vice president of research and development, Genomic Health. “Our extensive body of clinical evidence highlights the unique ability of our test to play a critical role in breast cancer treatment, while providing a positive impact on health systems worldwide. Based on NICE’s recommendation, we will work with NHS healthcare providers and commissioners to provide broad access to the Oncotype DX test for UK patients.”

The robust body of evidence supporting Oncotype DX includes 15 clinical studies in more than 6,000 patients; 18 decision impact studies from 10 countries, which consistently demonstrate an approximate 30 percent change in treatment recommendations; and more than 20 studies from nine countries, showing that the use of the test is cost-effective in all health systems analyzed.

Source: PR Newswire

Assurex Health Appoints Veteran P&G Consumer Products Executive Virginia Coleman Drosos President to Lead Personalized Medicine Growth

Assurex Health, a personalized medicine company specializing in pharmacogenomics for neuropsychiatric and other disorders, recently announced that Procter & Gamble veteran Virginia “Gina” Coleman Drosos has joined its leadership team in the role of President.

Drosos joins Assurex Health with more than 25 years of global business leadership, innovation, operations and consumer marketing expertise. During her 25 year career at The Procter & Gamble Company (PG), Gina held positions of increasing responsibility in the United States and internationally delivering strong proven results. She most recently served P&G as Group President for Global Beauty Care, a $6 billion global business unit with over 6,000 employees in 120 countries. 

“Gina brings extensive leadership and strong results on global consumer-driven businesses,” said James S. Burns, CEO of Assurex Health. “I’m particularly excited about Gina joining the team because health care is rapidly moving into an era of patient-empowerment, leading a shift to consumer-enabled personalized medicine. In bringing neuropsychiatric pharmacogenomics to a market of 40+ million patients in the U.S. alone, Assurex will benefit from Gina’s experience in creating awareness and cultivating a huge base of patients/consumers/caregivers, 80% of whom are women as the primary medical decision maker.”

Assurex Health’s pharmacogenomic technology is a breakthrough in personalized medicine. Based on each patient’s personal genetic profile, GeneSight tests help clinicians determine the right treatment medications for patients with depression, ADHD, chronic pain and other neuropsychiatric disorders. “Eliminating today’s typical trial and error process for selecting medications can help people reclaim their lives and reduces healthcare costs,” said Drosos. “I look forward to applying my experience leading in the consumer space to help make personalized medicine a standard of care in the industry. With exciting new innovations in the pipeline and our technology-information-consumer platform, I’m confident Assurex will help more physicians and practitioners determine the best treatment options and lead the movement toward consumer-enabled personalized medicine.”

Drosos also serves on the Board of Directors for several major corporations including Signet Jewelers Ltd. (SIG) and American Financial Group (AFG). Drosos earned a Bachelor of Business Administration in Finance from the University of Georgia, a Master of Business Administration from The Wharton School, University of Pennsylvania, and was recognized as one of Fortune’s 50 Most Powerful Women in Business in 2010 and 2011.

Source: PR Newswire

BIDMC Cardiovascular Institute Researchers Will Lead $4 Million NIH Grant to Study MicroRNAs

A cardiovascular research team from Beth Israel Deaconess Medical Center (BIDMC) and Brigham and Women’s Hospital (BWH), led by BIDMC Principal Investigator Saumya Das, MD, PhD, has been awarded a $4 million Common Fund grant from the National Institutes of Health (NIH) as part of a newly formed program on Extracellular RNA Communication. The five-year grant will focus on identifying microRNA biomarkers in heart disease.

Each year, complications from heart attacks (myocardial infarctions) contribute to more than half a million cases of heart failure and 300,000 cases of sudden cardiac arrest, when the heart suddenly stops. Both of these conditions are closely related to a process known as remodeling, in which the structure and function of the heart changes – or remodels — following a heart attack.

“Our goal is to explore the role that microRNAs play in predicting which heart-attack patients will go on to experience complications,” explains Das, an electrophysiologist in BIDMC’s Cardiovascular Institute and co-director of the cardiovascular genetics program within the Outpatient Cardiovascular Clinic.

“Current strategies used to identify the highest risk patients have often been inaccurate,” he adds. “We think that a blood test that makes use of microRNA biomarkers could replace existing strategies and more accurately predict which patients might experience poor outcomes and thereby identify who would most benefit from frequent monitoring and medical care.” Other investigators who are part of the NIH grant, “Plasma miRNA Predictors of Adverse Mechanical and Electrical Remodeling After Myocardial Infarction,” include BIDMC Director of Cardiovascular Research Anthony Rosenzweig, MD, and BWH investigators Raymond Y. Kwong, MD, MPH, and Mark Sabatine, MD, MPH.

microRNAs are one type of extracellular RNA. Once considered nothing more than genomic “junk,” microRNAs have more recently been recognized as playing a key role in cellular functions. Several years ago, scientists began to recognize that these small, noncoding RNAs were not only found inside cells, but could also be found in blood and other tissue fluids.

Using patient plasma samples from extensively characterized patients who have suffered heart attacks, the scientific team will first identify which specific microRNAs are related to poor heart remodeling. They will then use cell culture and animal models of heart disease to further prioritize which microRNAs play a functional role in disease progression. Finally, the investigators will validate these prioritized microRNAs as prognostic markers for poor health outcomes after heart attacks in a large prospective clinical trial.

“Ultimately, we think that miRNA-based tests could replace current tests to predict which patients might be at risk of complications and, therefore, be good candidates to receive an implanted defibrillator,” says Das. “At the same time, we hope to be able to better predict which individuals are at less risk of complications – and thereby spare them unnecessary and costly procedures.”

Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School, and currently ranks third in National Institutes of Health funding among independent hospitals nationwide.

BIDMC has a network of community partners that includes Beth Israel Deaconess Hospital-Milton, Beth Israel Deaconess Hospital-Needham, Anna Jaques Hospital, Cambridge Health Alliance, Lawrence General Hospital, Signature Health Care, Commonwealth Hematology-Oncology, Beth Israel Deaconess HealthCare, Community Care Alliance, and Atrius Health. BIDMC is also clinically affiliated with the Joslin Diabetes Center and Hebrew Senior Life and is a research partner of Dana-Farber/Harvard Cancer Center. BIDMC is the official hospital of the Boston Red Sox. For more information, visit www.bidmc.org.

Source: Beth Israel Deaconess Medical Center

Exosome Diagnostics Enters Collaboration Agreement with Lilly for Exosome Blood-Based Biomarker Discovery

Exosome Diagnostics recently announced it has entered into a collaboration agreement with Eli Lilly and Company (NYSE: LLY) for biomarker discovery and validation using Exosome Diagnostics proprietary EXO50 nucleic acid extraction kit. Under the agreement, Lilly will gain early access to Exosome Diagnostics technology to help identify key gene mutations and expression levels in blood that may be correlated with drug response and disease recurrence. Financial terms were not disclosed.

“Exosome Diagnostics technology may provide a unique opportunity to gain insight into the biology of complex conditions such as cancer and immune disorders,” said Andrew Schade, senior medical director, diagnostic and experimental pathology at Lilly. “Exosome technology enables biofluid molecular sampling and the ability to monitor disease progression in real time. As Lilly explores new ways to pursue patient tailoring, we’ll continue to work with partners to expand our capabilities.”

“Accessing high quality messenger and microRNA directly from frozen patient fluid samples offers a rapid, cost-effective route to identify and validate biomarkers, which may be correlated with drug response and disease recurrence,” said James McCullough, chief executive officer of Exosome Diagnostics. “Lilly has accumulated an extensive and well annotated clinical blood sample biobank that provides a unique opportunity to track target biomarkers through the clinical trial process and help overcome the limitations of stored biopsy tissue.”

Exosomes and other microvesicles are secreted by all cells into all biofluids, and provide a natural biological packaging and distribution mechanism for RNA and DNA. Exosome Diagnostics’ rapid exosome isolation and extraction technology produces high-quality RNA and DNA, including full length mRNA and microRNA, from small volumes of patient biofluids, such as blood (serum and plasma), urine and cerebrospinal fluid, for analysis by standard PCR, array and sequencing instruments. Analysis can be performed on fresh or frozen fluid samples, allowing for broad, flexible and convenient analyses of clinical trial samples, both in real-time and retrospectively, with no special preservation methods required. Exosomes and their protected nucleic acid contents are being investigated in a broad range of diseases including cancer, CNS disorders such as Alzheimer’s and Parkinson’s disease, cardiovascular disease, maternal/fetal medicine, and chronic kidney disease, among others. In July, QIAGEN and Exosome Diagnostics signed an agreement for the creation of High-Performance Biofluid Sample Preparation Kits for Personalized Healthcare Research which covers the exclusive supply of these products upon availability in 2014.

Source: Exosome Diagnostics