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Quintiles Releases Perspectives on Early Phase Oncology and Hematology Biomarkers

In advance of the American Society of Clinical Oncology (ASCO) Annual Meeting, Quintiles recently announced the release of its perspective on two areas of focus for clinical oncologists – the impact of patient selection in early-phase studies and the use of biomarkers in the treatment of hematologic malignancies.

The first of these reports, Tomorrow’s Path to Improved Early-Phase Oncology Drug Development, explores the importance of key elements to maximize quality and efficiency of go/no-go decisions in early-phase studies. As the understanding of the biology of cancer becomes more sophisticated and generates more opportunities, fundamental challenges caused by the complexities of this group of diseases are becoming more evident. Molecular profiling and leveraging molecular selection of patients has the potential to significantly improve the quality of early decisions in oncology drug development.

“By identifying a well defined group of patients with a particular molecular biological profile, we have the potential to make more efficient decisions on product candidates at the earliest possible stage,” said Philip Breitfeld, M.D., vice president and therapeutic strategy head, Quintiles. “As the cost of oncology drug development rises, the use of targeted therapies represents a path toward more precise treatment approaches that would drive down costs, timelines and failure rates.”

The second report, Biomarkers: Recent Advances in their Application to the Treatment of Hematologic Malignancies, presents a point of view on the value of biomarkers in the early detection and stratification of groups at risk for aggressive disease to improve the overall survival rates associated with late stage diagnosis.

Hematopoietic malignancies, which include a heterogeneous group of diseases such as multiple myeloma, lymphomas and leukemias, are characterized based on the appearance of the cells as well as demonstrating the presence or absence of certain cell surface proteins (Cluster of Differentiation or CD markers), characteristic chromosomal abnormalities, and by the identification of particular genetic mutations.

“While the use of biomarkers is widely supported and the hope of early detection is promising, few biomarkers have been identified or clinically validated for the early detection, progression or risk assessment for such malignancies,” said Harish Dave, M.D., MBA, vice president, global medical strategy head, hematology and oncology, oncology therapeutic area, Quintiles. “Recent advances in understanding of these malignancies and the advent of high-throughput technologies have the potential to facilitate rigorous translational research toward the discovery, development and clinical validation of novel biomarkers.”

Source: Quintiles

Entelos and ISB Announce Collaborative Gene Expression Breakthrough

Entelos Holding Corp. (“Entelos” or “the Company”), a premier provider of physiologicalsystemmodeling and services, and Seattle-based Institute for System Biology (ISB), the nonprofit pioneers of the systems approach to study the molecular causes of diseases, today announced the successful integration of gene expression data into quantitative physiological simulations. This proprietary capability improves understanding of the gene expression and disease outcomes to radically improve the predictive discernment of the complex nature of disease, yielding insights into novel therapeutic targets, biomarkers, and patient selection that should support a new era of precision medicine.

Entelos and ISB worked together to define a scientifically sound and scalable methodology to provide breakthrough capabilities for both the modeling and systems pharmacology communities. It addresses business-critical problems in both pharmaceutical research and healthcare. “This workflow is transformative for understanding the role of molecular interactions and their impact on pharmaceutical R&D and healthcare decision making,” stated Entelos Founder and CTO, Tom Paterson. “By utilizing our computer models, we are able to use all identified correlations across gene network studies to decipher genetic influence on the disruptions identified as disease. As an example, the new capabilities were able to help us clearly define from a pool of 51 potential biomarkers, and which biomarkers identified non-responders and responders for anti-IL1 therapies for rheumatoid arthritis.”

“The mapping and application of clinical gene expression data sets a new standard and role for quantitative physiological modeling within the drug discovery and development process,” stated Entelos President and CEO, Shawn O’Connor. “It’s only due to the unique depth and breadth of the Entelos quantitative physiological models that these sorts of mappings and analyses can be carried out across the entire pathophysiology of a disease. This is the beginning of truly understanding and leveraging the human genome for therapeutic success”

“As the interconnected features of the disease space become increasingly more visible, we are continuing to look for new ways to decipher the elaborate data that hides therapeutic success“ said Dr. Lee Hood, co-founder and president of Institute for Systems Biology and recipient of the National Medal of Science. “This approach represents a breakthrough capability for deriving insights from those data sets.”

This demonstrated convergence of top-down functional systems biology and bottom-up molecular systems biology provides an approach for using clinical gene expression data to investigate a wide diversity of diseases, to decipher disease complexity, and to understand variability and reduce uncertainty in populations and sub populations. Entelos and ISB are now seeking commercial partners to advance additional existing disease models (Atherosclerosis, Type 2 Diabetes, Hypertension, Rheumatoid Arthritis, etc.) and generate new in silico applications.

Source: Entelos

Merck and Luminex Corporation Enter Agreement to Develop Companion Diagnostic to Support Investigational BACE inhibitor Clinical Development Program for Alzheimer’s Disease

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Luminex Corporation (NASDAQ:LMNX) have signed a collaboration and license agreement to develop a companion diagnostic device that will be evaluated to help screen patients for recruitment into Merck’s clinical development program for MK-8931, a novel oral beta amyloid precursor protein site cleaving enzyme (BACE) inhibitor and Merck’s lead investigational candidate for Alzheimer’s disease (AD). Financial terms were not disclosed.

Moffitt Researchers Identify Unique Immune Gene Signature Across Thousands of Patients’ Solid Tumors

Researchers at Moffitt Cancer Center have discovered a unique immune gene signature that can predict the presence of microscopic lymph node-like structures in metastatic melanoma. The presence of these immune structures, the researchers said, appears to be associated with better survival and may indicate the possibility of selecting patients for immunotherapy based solely on the immune-related makeup of their tumors as an approach to personalized medicine.

NextGen Introduces its First Generation of Animal Biomarker Products for Development of Brain Disorder Diagnostics

NextGen Group Plc (AIM: NGG), the AIM listed company developing its own diagnostics product pipeline and providing diagnostic biomarker development services, announces the commercialisation of a new assay for the identification of diagnostic biomarkers in brain disorders in animal models.

The assay measures protein markers in rat cerebrospinal fluid and will expand the product offering of NextGen’s contract research subsidiary, NextGen Sciences Inc.

An assay is the procedure for measuring the effects of a chemical in an organism. For example, assays are used to discover biomarkers which are in turn used to identify the existence and progression of a disease. Biomarkers are used in clinical trials to aid in patient selection and to evaluate the effectiveness of a drug. They are also used in the development of companion diagnostics that will drive the growth of the personalised medicine market.

There is a significant need for biomarkers to monitor and diagnose central nervous system disorders, such as dementia, Parkinson’s disease and neuropsychological disorders, within the patient care and drug development industries.

NextGen’s “CSFassay-rat A.1.0” product is capable of measuring 62 cerebrospinal fluid (CSF) proteins simultaneously that have been identified as likely biomarkers in various central nervous system (CNS) disorders.

Barry McAleer, PhD, CEO of NextGen Sciences Inc says: “Assays that can discover biomarkers in animal models will enhance the drug development process within the pharmaceutical industry and could lead to reduced attrition in the drug development process. With the introduction of the CSFassay-rat A.1.0 we have delivered on the first phase of ongoing product development plans that enables us to support and enhance the pre-clinical drug development programs of our customers.This new product and those currently in development are already attracting interest in the marketplace and we are in discussions with a number of clients who wish to use these assays in their R&D programmes.”

The release of the CSFassay-rat A.1.0 product is the first assay in a family of animal model CSF assays and provides confirmation of NextGen’s previously stated intention to deliver assays in animal species.

Explains Barry McAleer: “Our customers can choose to employ our current assay products in their diagnostic biomarker programs or they can ask us to make custom assays for them, in multiple species, in CSF and plasma and for hundreds of proteins. We can do it in just a matter of weeks. “With our previously released human CSF and plasma assays we continue to widen the landscape for our customers to find diagnostic biomarkers in different animal species models. These biomarkers can be combined in a single assay that can be employed through the pre-clinical and clinical stages of drug development. This improves the chances for diagnostic markers to proceed all the way through to companion diagnostics and to aid the personalisation of medicine.”

NextGen uses mass spectrometry (a technique for specifically identifying and quantifying biomarkers in samples) as its core technology to discover highly specific protein biomarkers that can be used for diagnostic purposes.

“The speed with which we can develop these assays (three times faster than our previous assays), in multiple species and with hundreds of analytes, signifies a huge step forward in the speed with which we can look to grow our business.”

Klaus Rosenau, Chairman of NextGen Group PLC, explains: “We continue to strengthen our position towards becoming be a leader in providing high quality diagnostic biomarker assays. We intend to increase the speed with which we can exploit our technology and products within the project engine pipeline of the NextGen Sciences Dx business. Projects are already at different stages of development as we pursue our ambition to generate further intellectual property and seek out biomarker sale/licencing/testing routes to build shareholder value.”

In 2010, the total global market for biomarkers was an estimated $13.5 billion and is expected to grow to nearly $33.3 billion by the end of 2015 (BCC Research).

Source: NextGen Sciences