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West Clinic Researchers Present Findings at 2013 American Society for Clinical Oncology (ASCO) Meeting

The West Clinic, the Mid-South’s premier cancer center and world-class center of excellence in medical oncology, hematology, oncologic imaging, clinical research and other advanced medical care, recently announced five of its physician-researchers will participate in ten presentations at the 49th Annual American Society of Clinical Oncology (ASCO) Meeting to be held May 31-June 4, 2013 in Chicago, IL at the McCormick Palace. Over 30,000 members of the oncology community from across the nation and around the world are expected to attend the five-day international scientific and educational oncology conference. This year’s theme is “Building Bridges to Conquer Cancer.”

The West Clinic’s findings, which focus on leading-edge treatments for non-small cell lung cancer, colorectal cancer, lymphoma, and breast cancer, were selected by a highly competitive peer-review process.

“The West Clinic continues to further its research mission with a strong showing at ASCO, the world’s premier oncology meeting,” according to Lee S. Schwartzberg, MD, FACP, Medical and Research Director, The West Clinic; President, ACORN Research, LLC; and Chief, Division of Hematology/Oncology and Professor of Medicine, University of Tennessee Health Science Center. “Over 5000 abstracts from around the world were submitted this year. Our invitation to present four out of five West Clinic/ACORN abstracts reflects our reputation for being a major oncology research center. We are also pleased that our Chief Fellow, Dr. Jessica Snider, is first author on an important neo-adjuvant breast cancer trial that she will present.”

Landmark research has been a heritage of The West Clinic and its continued commitment to a robust program is strong with participation in approximately 40 open studies, 12 of which are Phase I. West Clinic physicians conduct a broad spectrum of clinical research trials ranging from Phase I to Phase IV studies in collaboration with major pharmaceutical companies, the National Cancer Institute, cooperative groups, and its own investigator initiated trials funded by grants. West Clinic has one of the most advanced research programs of its kind in the country and played a major role in the development of new drugs for breast cancer, colon cancer, lung cancer, prostate cancer, lymphoma, and many other diseases.

“This year’s theme Building Bridges to Conquer Cancer parallels our vision and unique collaboration with the University of Tennessee Health Science Center, Methodist Healthcare, and researchers across the country through ACORN Research, further positioning West Clinic as an innovative leader, exploring new cancer-fighting treatments, and saving more lives,” stated Dr. Schwartzberg.

The following West Clinic physicians contributed to ASCO presentations.

GENERAL POSTER PRESENTATIONS

  1. Dr. Lee Schwartzberg: Serum and tumor biomarkers to predict outcome in the eLung trial, a multicenter, randomized phase IIb study of standard platinum doublets (PD) plus cetuximab (CET) as first-line treatment of advanced non-small cell lung cancer (NSCLC). http://abstracts2.asco.org/AbstView_132_110479.html
  2. Dr. Lee Schwartzberg; Dr. Obiageli Ogbata: Real-world symptom burden and early treatment discontinuation in first-line metastatic breast cancer (MBC). http://abstracts2.asco.org/AbstView_132_110594.html
  3. Dr. Lee Schwartzberg: From Bayesian modeling to genomic mapping: Biologic validity of predictive single nucleotide polymorphism networks for chemotherapy-related side effects. http://abstracts2.asco.org/AbstView_132_114956.html
  4. Dr. Lee Schwartzberg: Phase I/II study of neoadjuvant carboplatin, eribulin mesylate, and trastuzumab (ECH) for operable HER2 positive (HER2+) breast cancer. http://abstracts2.asco.org/AbstView_132_110308.html
  5. Dr. Lee Schwartzberg: Analysis of KRAS/NRAS mutations in PEAK: A randomized phase II study of FOLFOX6 plus panitumumab (pmab) or bevacizumab (bev) as first-line treatment (tx) for wild-type (WT) KRAS (exon 2) metastatic colorectal cancer (mCRC). http://abstracts2.asco.org/AbstView_132_116726.html
  6. Dr. Lee Schwartzberg: Initial results from the 21-gene breast cancer assay registry: A prospective observational study in patients (pts) with ER+, early-stage invasive breast cancer (EBC). http://abstracts2.asco.org/AbstView_132_113096.html
  7. Dr. Lee Schwartzberg: Phase II study of lapatinib in combination with vinorelbine, as first- or second-line therapy in women with HER2-overexpressing metastatic breast cancer. http://abstracts2.asco.org/AbstView_132_115057.html
  8. Dr. Jessica Snider: Pathologic complete response (pCR) with weekly nanoparticle albumin bound (nab-P) plus carboplatin (C) followed by doxorubicin plus cyclophosphamide (AC) with concurrent bevacizumab (B) for triple-negative breast cancer (TNBC). http://abstracts2.asco.org/AbstView_132_117576.html
  9. Dr. Brad Somer: Randomized phase II study with window-design to evaluate anti-tumor activity of the survivin antisense oligonucleotide (ASO) ly2181308 in combination with docetaxel for first-line treatment of castrate-resistant prostate cancer (CRPC). http://abstracts2.asco.org/AbstView_132_108714.html
  10. Dr. Daruka Mahadevan: Genetic and cytokine profiles associated with symptomatic stage of CLL. http://abstracts2.asco.org/AbstView_132_113916.html

PUBLICATIONS ONLY

  1. Dr. Lee Schwartzberg: A phase IIb trial of coix seed injection for advanced pancreatic cancer. http://abstracts2.asco.org/AbstView_132_115489.html
  2. Dr. Daruka Mahadevan: Phase Ib study of safety, tolerability, and efficacy of R1507 a monoclonal antibody to IGF-1R in combination with multiple standard chemotherapy regimens in patients with advanced solid malignancies. http://abstracts2.asco.org/AbstView_132_110601.html

Source: PR Newswire

Genomind Releases Statement Supporting NIMH Announcement to Move Away from DSM Categories

Genomind, a personalized medicine company, has released a statement in response to the National Institute of Mental Health’s (NIMH) announcement by Director Dr. Thomas Insel that the organization will be re-orienting its research away from DSM categories, supporting the move and its potential to influence improved treatment of patients with mental disorders.

DSM (Diagnostic and Statistical Manual of Mental Disorders) is a psychiatric diagnostics system based upon patient-reported symptoms that are used to define succinct syndromes and make medication choices. While the system has been in place for decades, it has not taken into consideration patient etiology or pathophysiology.

The remedy proposed by NIMH is the Research Domain Criteria (RDoC) Project, which would alter procedures to include genetics, imaging, cognitive science, and other specific endophenotypes which reflect specific changes in the brain associated with psychiatric conditions, creating a fuller understanding of both a patient’s disorder and how to best address treatment.

Genomind believes that the use of biomarkers in psychiatry can only help improve patient care. Better knowledge of a patient’s genetics can lead to better medication choices by reducing adverse drug side effects, which are based upon genetic impairments in drug metabolism. Continued research and focus on biomarkers may also help the industry understand underlying pathophysiological changes in the brain that lead to psychiatric disorders.

“The core of Genomind’s philosophy is that psychiatric disorders are dimensional, not categorical, and NIMH’s position directly supports this,” says Dr. Jay Lombard, Genomind’s Chief Scientific Officer and Medical Director. “We hope this move by the NIMH and the resulting RDoC Project will not only allow patients to receive more personalized, tailored care, but help the mental health community gain greater insight into how we can improve treatment even further in the future.”

Genomind is committed to discovery of the underlying causes of neuropsychiatric disorders and supports the development of personalized medicine that improves patients’ lives. The company’s core product is the GeneceptTM Assay, a comprehensive, simple-to-use tool for understanding genetic and biological markers that best inform response to different psychiatric treatments including depression, bipolar disorder, schizophrenia, anxiety disorders, autism and ADHD.

Source: Genomind

Atrophy in Key Region of Brain Associated with Multiple Sclerosis

Magnetic resonance imaging (MRI) measurements of atrophy in an important area of the brain are an accurate predictor of multiple sclerosis (MS), according to a new study published online in the journal Radiology. According to the researchers, these atrophy measurements offer an improvement over current methods for evaluating patients at risk for MS.

MS develops as the body’s immune system attacks and damages myelin, the protective layer of fatty tissue that surrounds nerve cells within the brain and spinal cord. Symptoms include visual disturbances, muscle weakness and trouble with coordination and balance. People with severe cases can lose the ability to speak or walk.

Approximately 85 percent of people with MS suffer an initial, short-term neurological episode known as clinically isolated syndrome (CIS). A definitive MS diagnosis is based on a combination of factors, including medical history, neurological exams, development of a second clinical attack and detection of new and enlarging lesions with contrast-enhanced or T2-weighted MRI.

“For some time we’ve been trying to understand MRI biomarkers that predict MS development from the first onset of the disease,” said Robert Zivadinov, M.D., Ph.D., FAAN, from the Buffalo Neuroimaging Analysis Center of the University at Buffalo in Buffalo, N.Y. “In the last couple of years, research has become much more focused on the thalamus.”

The thalamus is a structure of gray matter deep within the brain that acts as a kind of relay center for nervous impulses. Recent studies found atrophy of the thalamus in all different MS disease types and detected thalamic volume loss in pediatric MS patients.

“Thalamic atrophy may become a hallmark of how we look at the disease and how we develop drugs to treat it,” Dr. Zivadinov said.

For this study, Dr. Zivadinov and colleagues investigated the association between the development of thalamic atrophy and conversion to clinically definite MS.

“One of the most important reasons for the study was to understand which regions of the brain are most predictive of a second clinical attack,” he said. “No one has really looked at this over the long term in a clinical trial.”

The researchers used contrast-enhanced MRI for initial assessment of 216 CIS patients. They performed follow-up scans at six months, one year and two years. Over two years, 92 of 216 patients, or 42.6 percent, converted to clinically definite MS. Decreases in thalamic volume and increase in lateral ventricle volumes were the only MRI measures independently associated with the development of clinically definite MS.

“First, these results show that atrophy of the thalamus is associated with MS,” Dr. Zivadinov said. “Second, they show that thalamic atrophy is a better predictor of clinically definite MS than accumulation of T2-weighted and contrast-enhanced lesions.”

The findings suggest that measurement of thalamic atrophy and increase in ventricular size may help identify patients at high risk for conversion to clinically definite MS in future clinical trials involving CIS patients.

“Thalamic atrophy is an ideal MRI biomarker because it’s detectable at very early stage,” Dr. Zivadinov said. “It has very good predictive value, and you will see it used more and more in the future.”

The research team continues to follow the study group, with plans to publish results from the four-year follow-up next summer. They are also trying to learn more about the physiology of the thalamic involvement in MS.

“The next step is to look at where the lesions develop over two years with respect to the location of the atrophy,” Dr. Zivadinov said. “Thalamic atrophy cannot be explained entirely by accumulation of lesions; there must be an independent component that leads to loss of thalamus.”

MS affects more than 2 million people worldwide, according to the Multiple Sclerosis International Foundation. There is no cure, but early diagnosis and treatment can slow development of the disease.

Source: Thalamic Atrophy is Associated with Development of Clinically Definite Multiple Sclerosis

Source: EurekAlert!

Alzheimer’s Markers Predict Start of Mental Decline

Scientists at Washington University School of Medicine in St. Louis have helped identify many of the biomarkers for Alzheimer’s disease that could potentially predict which patients will develop the disorder later in life. Now, studying spinal fluid samples and health data from 201 research participants at the Charles F. and Joanne Knight Alzheimer’s Disease Research Center, the researchers have shown the markers are accurate predictors of Alzheimer’s years before symptoms develop.

“We wanted to see if one marker was better than the other in predicting which of our participants would get cognitive impairment and when they would get it,” said Catherine Roe, PhD, research assistant professor of neurology. “We found no differences in the accuracy of the biomarkers.”

The study, supported in part by the National Institute on Aging, appears in Neurology.

The researchers evaluated markers such as the buildup of amyloid plaques in the brain, newly visible thanks to an imaging agent developed in the last decade; levels of various proteins in the cerebrospinal fluid, such as the amyloid fragments that are the principal ingredient of brain plaques; and the ratios of one protein to another in the cerebrospinal fluid, such as different forms of the brain cell structural protein tau.

The markers were studied in volunteers whose ages ranged from 45 to 88. On average, the data available on study participants spanned four years, with the longest recorded over 7.5 years.

The researchers found that all of the markers were equally good at identifying subjects who were likely to develop cognitive problems and at predicting how soon they would become noticeably impaired.

Next, the scientists paired the biomarkers data with demographic information, testing to see if sex, age, race, education and other factors could improve their predictions.

“Sex, age and race all helped to predict who would develop cognitive impairment,” Roe said. “Older participants, men and African Americans were more likely to become cognitively impaired than those who were younger, female and Caucasian.”

Roe described the findings as providing more evidence that scientists can detect Alzheimer’s disease years before memory loss and cognitive decline become apparent.

“We can better predict future cognitive impairment when we combine biomarkers with patient characteristics,” she said. “Knowing how accurate biomarkers are is important if we are going to some day be able to treat Alzheimer’s before symptoms and slow or prevent the disease.”

Clinical trials are already underway at Washington University and elsewhere to determine if treatments prior to symptoms can prevent or delay inherited forms of Alzheimer’s disease. Reliable biomarkers for Alzheimer’s should one day make it possible to test the most successful treatments in the much more common sporadic forms of Alzheimer’s.

Study: Amyloid imaging and CSF biomarkers in predicting cognitive impairment up to 7.5 years later

Source: EurekAlert!

The Michael J. Fox Foundation Launches New Arm Of Parkinson’s Progression Markers Initiative Studying At-Risk Populations In Parkinson’s Disease

The Parkinson’s Progression Markers Initiative (PPMI), a landmark biomarker clinical study, has completed enrollment of its initial 600-member cohort of Parkinson’s patients and controls, and will launch additional study cohorts to leverage the existing PPMI infrastructure and evaluate multiple potential biomarkers for Parkinson’s disease (PD). The first of these new cohorts launches today and will investigate risk factors for PD that may enable diagnosis before the onset of motor symptoms.

The pre-motor arm of PPMI will enroll participants who do not have Parkinson’s disease but do have one of three potential risk factors for PD: a reduced sense of smell (hyposmia); rapid eye movement sleep behavior disorder (RBD); or a mutation in the LRRK2 gene (the single greatest genetic contributor to PD known to date). Research to date indicates that each of these factors can be linked to an increased risk of developing Parkinson’s disease, though many people with these conditions do not go on to develop PD. Validating these risk factors and better characterizing their connection to Parkinson’s could enable detection of the disease prior to the onset of motor symptoms and open new avenues toward identifying biomarkers — critical tools in the quest for therapies that can slow or stop disease progression.

“If scientists can learn more about the biological processes taking place in people with any of these three risk factors, we may be able to define biomarkers even before typical symptoms begin,” said Ken Marek , MD, principal investigator of PPMI and president and senior scientist at the Institute for Neurodegenerative Disorders in New Haven, Connecticut. “Finding a biomarker for PD could mean earlier diagnosis of the disease and lead to new drugs that may delay or even prevent the onset of motor symptoms.”

PPMI seeks 10,000 individuals to complete a brief online survey to determine eligibility for the loss-of-smell cohort. Participants in the other groups will largely be enrolled via research centers. This new arm will take place at 23 sites across the world where participants will undergo the same clinical assessments, imaging and collection of biospecimens as the original study.

PPMI’s open-source design and infrastructure has opened the door to evaluating multiple potential biomarkers under one umbrella, building on a precedent created by the Alzheimer’s Disease Neuroimaging Initiative (ADNI). All PPMI clinical data and characterized biosamples are available in real time, providing researchers around the world with an unprecedented resource to help speed and unify disparate biomarker validation studies. To date, 460 scientists from academia and industry have downloaded PPMI data more than 50,000 times in over 30 countries worldwide, and 21 applications have been made for use of PPMI biospecimens in biomarker research. Initial baseline data from PPMI’s original newly diagnosed and control cohorts will be presented this June at the Movement Disorders Society and is expected to be published later this year.

“Lessons learned from Alzheimer’s have taught us the importance of pursuing biomarker research concurrent with therapeutic development,” said Todd Sherer , Ph.D., CEO of The Michael J. Fox Foundation for Parkinson’s Research. “In the third year of PPMI, it is evident that a large-scale biomarker study is not only possible in Parkinson’s disease, but is already yielding scientific insights that could help transform the field’s pursuit of a cure.”

Source: PR Newswire