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Brain Inflammation Linked to More Severe Parkinson’s Symptoms

Reversing inflammation in the fluid surrounding the brain’s cortex may provide a solution to the complex riddle of Parkinson’s, according to researchers who have found a link between pro-inflammatory biomarkers and the severity of symptoms such as fatigue, depression and anxiety in patients with the chronic disease.

Lena Brundin of Michigan State University’s College of Human Medicine was part of a research team that measured inflammatory markers found in cerebrospinal fluid samples of Parkinson’s patients and members of a control group.

“The degree of neuroinflammation was significantly associated with more severe depression, fatigue, and cognitive impairment even after controlling for factors such as age, gender and disease duration,” said Brundin, an associate professor in the college and a researcher with the Van Andel Institute.

“By investigating associations between inflammatory markers and non-motor symptoms we hope to gain further insight into this area, which in turn could lead to new treatment options.”

The results of the study were published in the journal Brain, Behavior, and Immunity.

Inflammation in the brain long has been suspected to be involved in the development of Parkinson’s disease, specifically in non-motor symptoms such as depression, fatigue and cognitive impairment. Recent research suggests inflammation could drive cell death and that developing new drugs that target this inflammation might slow disease progression.

Parkinson´s disease is the second most common degenerative disorder of the central nervous system; the causes of the disease and its development are not yet fully understood.

“The few previous studies investigating inflammatory markers in the cerebrospinal fluid of Parkinson’s patients have been conducted on comparatively small numbers of subjects, and often without a healthy control group for comparison,” Brundin said.

In the study, 87 Parkinson’s patients were enrolled between 2008 and 2012. For the control group, 37 individuals were recruited. Participants underwent a general physical exam and routine blood screening. Researchers looked at the following markers: C-reactive protein, interleukin-6, tumor necrosis factor-alpha, eotaxin, interferon gamma-induced protein-10, monocyte chemotactic protein-1 and macrophage inflammatory protein 1-β.

The study was carried out in collaboration with researchers from Lund University in Sweden, Skåne University Hospital in Sweden and the Mayo Clinic College of Medicine in Florida.

Study: Cerebrospinal fluid inflammatory markers in Parkinson’s disease – Associations with depression, fatigue, and cognitive impairment [Brain, Behavior, and Immunity]

Source: EurekAlert!

Takeda and Zinfandel Pharmaceuticals Initiate Phase 3 TOMMORROW Trial of AD-4833 for the Delay of Onset of Mild Cognitive Impairment Due to Alzheimer’s Disease in Subjects Selected Using a Genetic-Based Biomarker Risk Assignment Algorithm

Takeda Pharmaceutical Company Limited (“Takeda”) and its partner, Zinfandel Pharmaceuticals, Inc. (“Zinfandel”), recently announced the initiation of TOMMORROW, a global Phase 3 clinical trial investigating a genetic-based biomarker risk assignment algorithm (risk assignment algorithm) to predict risk of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) within a five year period and to evaluate the efficacy of the investigational low dose pioglitazone (designated AD-4833 for this use) in delaying the onset of MCI due to AD in cognitively normal individuals at high risk as determined by the risk assignment algorithm.

The risk assignment algorithm is comprised of apolipoprotein E (APOE) and TOMM40 genotypes and age. Age and APOE genotype have previously been shown to indicate elevated risk of AD. The addition of TOMM40 is hypothesized to further refine the risk determination.

“To date, there have been a number of avenues investigated with the goal of altering the course of Alzheimer’s disease but results have been unsuccessful,” said Allen Roses, M.D., Chief Executive Officer, Zinfandel. “This is why the TOMMORROW trial is important. The potential to identify an individual’s risk for developing MCI due to AD warrants further investigation.”

AD is a devastating disease and diagnoses are increasing as the world’s population ages. Currently 35.6 million people worldwide are living with some form of dementia. Studies show that individuals with MCI are at an increased risk of developing AD or another dementia with conversion rates of approximately 15 percent per year.

“AD-4833 is a member of a class of drugs known as PPAR (peroxisome proliferator-activated receptor)-gamma agonists which available data show may have a beneficial role in delaying symptoms of MCI due to AD,” noted Stephen Brannan, M.D., Central Nervous System Development Therapeutic Area Head, Takeda. “TOMMORROW is a significant study and represents a novel clinical milestone and trial for the Alzheimer’s community as it evaluates pre-symptomatic patients.”

Source: Taleda Pharmaceutical Company Limited

Nodality, Inc. Reports Promising Rheumatoid Arthritis Study Results to Predict Patient Treatment Response to TNF Inhibitors

Nodality, Inc., an innovative biotechnology company advancing discovery, development and use of transformative therapies by revealing functional systems biology, recently announced results of the Company’s comprehensive research study to identify cell markers (biomarkers) of disease activity and treatment success in rheumatoid arthritis (RA) patients. The study findings demonstrated that Nodality’s SCNP technology, which measures functional pathways at the single cell level, can be used to identify biomarkers of responsiveness to treatment with tumor necrosis factor inhibitors (TNFIs). RA affects an estimated two million Americans, and TNFIs constitute the most commonly prescribed therapy. Approximately half of patients respond to treatments such as TNFIs, leaving a substantial unmet need to identify which patients are more likely to respond to current therapies. Optimizing use of currently available therapies could potentially delay tissue damage and progression of disease.

SCNP provides the core technology foundation for Nodality’s programs dedicated to improving clinical medicine by increasing the efficiency of therapeutic R&D programs, enhancing life cycle management for commercialized drugs, and introducing new predictive diagnostics. The study results were featured in an oral presentation titled, Comparison of functional immune signaling profiles in peripheral blood mononuclear cells (PBMC) from rheumatoid arthritis (RA) patients versus healthy donors (HD) using Single Cell Network Profiling (SCNP) (Abstract W7.02.04), at the 15th International Congress of Immunology (ICI) in Milan, Italy, taking place August 22 to 27, 2013. The findings were presented by S. Louis Bridges, Jr., M.D., Ph.D., Marguerite Jones Harbert-Gene V. Ball, MD Professor of Medicine, Director, Division of Clinical Immunology and Rheumatology, University of Alabama School of Medicine.

“Nodality’s research program demonstrates the great promise and potential in gaining a better understanding of disease biology and applying this to the development of prognostic and predictive biomarkers for autoimmune diseases such as RA,” commented Alessandra Cesano, M.D., Ph.D., Chief Medical Officer of Nodality. “I look forward to the final results of this program, one of the most comprehensive of its kind. Our technology, based on immune-biology, can predict which RA patients will respond to specific therapies and reveal the mechanisms of drug resistance, thus informing alternative therapeutic strategies.”

The Nodality research program compares healthy and diseased peripheral blood cells at the single cell level, studying samples obtained through the national Treatment Efficacy and Toxicity in Rheumatoid Arthritis Database and Repository (TETRAD). Nodality anticipates completing its research program and announcing the key findings later this year.

Laura Brege, Nodality’s President and Chief Executive Officer, stated, “ICI has provided an important opportunity to showcase one of our key programs in immunology, further validating our broadly enabling SCNP platform. This platform has led to major collaborations in immunology addressing significant unmet needs among patients, as well as new predictive diagnostic modalities in blood cancers. Ultimately, Nodality’s goal is to accelerate and make more efficient the development of new therapeutic agents for serious diseases affecting large patient populations within immunology and oncology, two areas of continuing significant unmet clinical need.”

Additional program results were featured in a second oral presentation at the ICI Congress in a presentation titled, Functional proteomic interrogation of immune cell crosstalk and the effects of cytokine-targeted inhibitors using Single Cell Network Profiling (SCNP) (Abstract W7.02.03).

Source: Nodality, Inc

Discovered a Genetic Biomarker that Detects Lewy Body Dementia

The Germans Trias i Pujol Health Sciences Research Institute (IGTP) and the Universitat Autònoma de Barcelona (UAB) have discovered the first genetic biomarker to detect Lewy body dementia (LBD), a disease that can be confused with Alzheimer’s. This biomarker is found in 20% of cases and differentiates one of the sub-groups of the pathology. Licensed to the Grifols company, it will lead to more precise diagnosis and treatment.

Lewy body dementia (LBD) is the second cause of dementia after Alzheimer’s disease. The symptoms of both diseases are very similar, since in both cases there is a gradual deterioration in mental capacity, affecting memory, thought processes, behaviour and physical activity. These similarities mean that some patients with LBD are wrongly diagnosed and treated with the usual drugs for Alzheimer’s. But this treatment causes adverse reactions in approximately half of these patients, making the disease much worse in some cases.

Currently there is no specific test to diagnose LBD. In practice, various neurological and neuropsychological tests are used to detect the disease and its possible overlap with other disorders, but clinical diagnosis of LBD is not very accurate.

The research, conducted by the IGTP and the UAB, has led to the discovery of the first genetic biomarker, found in 20% of LBD cases, and differentiating between one sub-group of LBD and Alzheimer’s disease. “Although this marker only detects a certain number of LBD sufferers, it significantly increases diagnostic sensitivity to the disease and these patients can get an accurate diagnosis and therefore the right treatment”, explains Dr Katrin Beyer, head of the research project and belonging to the Group of Structural and Molecular Pathology, Department of Pathology at the Germans Trias Hospital and Institute.

The researchers first detected the marker through a study of post mortem brain samples, in which they observed an alteration in the expression of the enzyme butyrylcholinesterase (BCHE) in the brains of patients with LBD. These data indicated that there could be genetic alterations in the BCHE gene promoter, causing changes in the expression of the gene. In fact, they found four polymorphisms in the LBD promoter region that, in certain combinations, are associated with LBD. These findings, which have been patented, make it possible to determine if a patient has LBD, distinguishing it from Alzheimer’s disease.

Currently, the patent is in its last stage of validation, which is being carried out in collaboration with neurologists from the Neurodegenerative Disease Unit of the Germans Trias Hospital and Bellvitge Hospital.

The licensing agreement with the Grifols company means the results can be applied, thus providing a simple, rapid, and effective procedure for diagnosing LBD in hospitals. Moreover, the marker can also be used to design clinical studies to help identify groups of patients with a more accurate diagnosis, removing, for example, LBD cases from a group of Alzheimer’s patients.

Grifols is a global company that for over 70 years has been providing therapeutic treatments with plasmatic proteins, technology for clinical diagnosis and pharmaceutical products for hospital use. It is now the third worldwide producer of biological drugs derived from plasma, is present in over 100 countries and is a world leader in plasma supplies, with 150 blood donation centres in the United States.

Source: EurekAlert!

Quest Diagnostics Introduces Comprehensive Opioid Therapy Genetic Test Based on CYP450 Biomarker License with Transgenomic

Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, recently announced the availability of a new lab-developed genetic test to aid the delivery of personalized opioid pain-relieving treatment. It is believed to be the first clinical lab to offer testing for variants in all cytochrome P450 (CYP450) genes known to influence the CYP450 enzyme system, which affects metabolism of opioids and other medications.