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COPD Biomarker Qualification Consortium Making Strides with Plasma Fibrinogen as New Biomarker

The COPD Biomarkers Qualification Consortium (CBQC) recently announced at the European Respiratory Society Annual Congress that it has submitted a Qualification Package to the Food and Drug Administration (FDA) for plasma fibrinogen as a new drug development tool. The Qualification Package is the result of progressive discussions between the FDA’s Qualification Review Team and the CBQC. The CBQC looks forward to the results of FDA review while planning for a fall 2013 submission to the European Medicines Agency.

Dr. Ruth Tal-Singer, CBQC co-chair, vice president, Clinical Discovery, Respiratory Area Therapy Unit at GlaxoSmithKline, notes, “To the best of CBQC’s knowledge, fibrinogen is the first clinical biomarker achieving this milestone in the U.S. This is a major milestone for the CBQC, and it highlights the power of working together across multiple companies, academic centers and government organizations to achieve our common objective of improving the way we study novel medicines for patients who need them.”

To support the submission, the CBQC compiled a unique database of subjects from five individual studies, allowing integrated analyses to support two proposed uses as a prognostic biomarker to enrich clinical trial populations with Chronic Obstructive Pulmonary Disease (COPD) subjects at increased risk for all-cause mortality or COPD exacerbations.

A biomarker is a tool that can be used for early detection of a disease, selection of subjects for clinical trials or as an outcome for clinical trials. Fibrinogen, a protein that can be measured in the blood, is a promising biomarker which identifies a group representing 25 to 30 percent of all COPD patients (a COPD subtype).

Dr. Stephen Rennard, CBQC co-chair and Larson Professor of Medicine, University of Nebraska, adds, “COPD is extremely heterogeneous. This complicates development of new treatments, as individual COPD patients may respond differently. Fibrinogen has been submitted to the FDA as a tool that will help address this problem. Specifically, fibrinogen measurement can help identify COPD patients at risk for death or hospitalization, which can allow individuals to participate in studies of novel treatments designed to improve those outcomes.”

The CBQC, organized under the auspices of the COPD Foundation, is a public-private partnership among academic researchers, pharmaceutical companies and government parties and agencies.

John W. Walsh, president and co-founder, COPD Foundation, states, “The Consortium is providing a unique and productive opportunity to bring new drug development tools to the research community, with the ultimate goal of providing new treatments to patients who urgently need them.”

The CBQC Fibrinogen Working Group is composed of the following members:

  • Bruce Miller, industry co-chair, GlaxoSmithKline
  • Ruth Tal-Singer, GlaxoSmithKline
  • Mike Lowings, GlaxoSmithKline
  • Ubaldo Martin, AstraZeneca
  • Jeff Snyder, Boehringer-Ingelheim
  • Kay Tetzlaff, Boehringer-Ingelheim
  • Armin Furtwaengler, Boehringer-Ingelheim
  • Nicholas Locantore, GlaxoSmithKline
  • Nancy Leidy, Evidera
  • Amber Martin, Evidera
  • Jason Simeone, Evidera
  • David Mannino, academic co-chair, University of Kentucky
  • Stephen Rennard, University of Nebraska
  • David Lomas, University College London, U.K.
  • Jorgen Vestbo, University of Southern Denmark, University Hospital Manchester, U.K.
  • Graham Barr, Columbia University
  • Debora Merrill, COPD Foundation

Source: COPD Foundation

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

MentisCura to Deploy EEG Diagnostics for Dementia at China’s Largest Geriatric Hospital in 2014

MentisCura Diagnostics (www.mentiscura.com) and WanJiaYuan International Geriatric Hospital recently announced the signing of an agreement to implement MentisCura’s proprietary diagnostic tools to improve care for patients with CNS disorders.

Mentiscura’s diagnostics will be part of a state-of-the art technology suite being deployed at the WanJiaYuan International Geriatric Hospital, expected to open in June 2014. The hospital, based in Nanyang in the Henan province, will be a 120,000 square meter, 1200 bed campus, one of the largest facilities of its kind in the world to focus solely on setting new standards of quality of managed care for the elderly, with at least 200 beds dedicated to dementia patients. WanJiaYuan International Geriatric Hospital also aims to establish a leadership position in geriatric research through the development of a center of excellence attracting over 100 international experts.

“We are honoured to be associated with a project that is of an unprecedented scale, even by international standards. The high-throughput and non-invasive nature of our electrophysiological analysis makes it uniquely useful in a real world clinical setting, where physicians need to assess patients and make care decisions before these diseases have reached a late and untreatable stage. From a five-minute standard EEG recording, our powerful analytical systems are able to provide immediate diagnostic output, offering genuine clinical benefit and scalability for even the largest facilities,” said Kristinn Gretarsson, CEO of MentisCura.

“Our hospital is committed to addressing the growing burden of care associated with diseases of ageing. We are delighted to be collaborating with MentisCura to use its innovative clinical technologies to guide earlier, lower cost diagnosis. We believe that biomarkers of disease will increasingly play an important role in our diagnostic protocol for dementia, as well as monitoring of disease progression and treatment efficacy,” commented Dr. Jin-Jing Pei, MD, Chief Physician at WanJiaYuan International Geriatric Hospital.

MentisCura offers a complete, integrated service to hospitals and general practitioners through sampling, processing and analysis of patient EEG data. The MentisCura Analysis System is a CE marked diagnostic aid, based on advanced, proprietary EEG-biomarker technology platform that accurately correlates changes in electrophysiology to specific disease pathologies, based on the company’s comprehensive proprietary EEG database for dementia and cognitive disorders. The platform supports diagnoses for most common types of dementia, including Alzheimer’s disease and Lewy body dementia.

Source: MentisCura Diagnostics

Life Technologies and RainTree Oncology Services Announce Collaboration to Bring Molecular Tumor Testing to Community Oncologists

Life Technologies Corporation (NASDAQ: LIFE) and RainTree Oncology Services recently announced they have entered into a collaboration agreement designed to further the advancement of personalized care for cancer patients.

Through the collaboration, RainTree and Life Technologies will seek to make the latest advances in molecular testing available to the broader patient market and will work to develop a streamlined protocol for entering patients into clinical trials for new targeted therapies.

Key elements of the collaboration are:

  • Collaborate on matching oncology patients to clinical trials using a Next Generation Sequencing Oncology screening panel;
  • Develop a clinical trials recruitment database which incorporates RainTree’s broad patient data set, enhanced by other data sources, including Life’s Compendia analytics engine;
  • Educate private payors and health plans about the benefits of Next Generation Sequencing; and
  • Build and market comprehensive product, test and data offerings for clinical research organizations.

“Today’s announcement emphasizes RainTree Oncology Services’ commitment to providing access to cutting edge capabilities to the over 600 community oncologists and approximately 40 practices that we serve,” said Mike Martin, chief executive officer of RainTree. “The world of personalized medicine is moving very fast, and the collaboration with Life Technologies ensures we stay active in the development of advanced molecular diagnostic capabilities to connect our physicians and patients with the latest in therapeutic discovery.”

“Our goal is to ensure that patients in the community setting have the same access to advanced technologies, such as genetic sequencing, as patients in the top academic centers,” said Ronnie Andrews, president of genetic and medical sciences at Life Technologies. “This collaboration also establishes a mechanism for pharmaceutical companies to identify the patients they need for clinical trials to bring new, targeted therapies to market.”

“Life Technologies and RainTree Oncology share a mutual commitment to improving cancer care in the community setting, where the majority of patients are diagnosed and treated,” said Andrews.

Through the collaboration, Life Technologies intends to participate in development of next generation sequencing panels that will allow for deep interrogation of tumors. Additional assays may also be developed under the collaboration. Patient data will be housed in a de-identified format in a proprietary database, which will be made available to pharmaceutical companies to recruit Phase 1 patients, as well as to participating clinical research organizations to support recruitment for later phase trials.

The agreement provides for RainTree and Life Technologies to leverage RainTree’s data sets, and utilize the information to enrich patient populations for early phase clinical trials and apply advanced bioinformatics techniques via Life Technologies’ proprietary Compendia Oncomine® solution to help identify targeted therapeutics for trials on certain tumor genotypes.

More than one half of cancer patients are seen in community oncology practices, according to Inside Oncology, Academic Cancer Centers (NCCC). The more than 500 new targeted compounds currently in development are leading to a large unmet need for recruitment of patients based on specific molecular profiles.

“Efficiently identifying clinical trial candidates for new targeted therapies has presented an obstacle in bringing new drugs to market,” said Dr. Jeff Patton, chief medical officer of RainTree and chief executive officer of Tennessee Oncology. “Through our collaboration with Life Technologies, we will be able to tap into new genetic information that, along with our existing data sets, will help guide patients to enroll in clinical trials based on the genetic signatures of their tumors.”

Source: Life Technologies

Syapse Joins Free the Data! Initiative and Provides Software to Power Participant-centric Hereditary Gene Mutation Database

Syapse, the leader in software for bringing omics into routine medical use, announced that it has joined the Free the Data! initiative. This consortium of policy makers, advocacy organizations, individuals, academic centers, and industry aims to fill the public information gap caused by the lack of available genetic information for the BRCA1 and BRCA2 genes, and plans to expand to provide other types of genetic information in an open, searchable database.

Syapse will provide the software infrastructure for the Free the Data! initiative, enabling powerful data mining, visualization, and reporting. Participants will be able to visualize their own variations and clinical data in comparison to those already in the database, while clinicians will be able to utilize variant interpretation in medical interactions. Researchers, industry, and others can utilize Syapse data mining tools to interrogate the variants, interpretation, and evidence, along with clinical data submitted by participants. Participants will have full control over data sharing and privacy preferences of the data they contribute. The campaign shares all variants with ClinVar, the National Institutes of Health public database, unless the participant dictates otherwise.

“Despite national attention on the patentability of human genes, a ruling against gene patentability doesn’t immediately provide broad access to BRCA1 and BRCA2 variants or place them in a public database that will allow for better diagnosis and care,” said Sharon F. Terry, M.A., president and CEO of Genetic Alliance. “Syapse provides the best platform for integrating complex genomics and clinical data from disparate sources, and reporting it in a dynamic and relevant interface to participants and clinicians. We are excited to be using Syapse software to enable all individuals to access genetic mutations and their clinical interpretations in order to improve care.”

“Syapse is pleased to join Genetic Alliance, University of California San Francisco (UCSF), InVitae Corporation, and advocates in the Free the Data! initiative to crowdsource the interpretation of BRCA1 and BRCA2 variants,” said Jonathan Hirsch, Founder & President of Syapse. “Syapse is committed to the free and open interpretation of the genome, but interpreting the genome requires a larger evidence base than any one entity can develop. Pooling genetic and clinical data will rapidly advance medical knowledge of clinically relevant genetic mutations, leading to more effective diagnosis, treatment, and cures.”

Individuals who have received genetic testing and who are interested in participating are invited to go to the Free The Data! project web site at www.free-the-data.org, and follow the instructions to upload test results, set privacy and sharing settings, and answer a brief questionnaire.

Individuals may also send a scan or PDF of the test report form with the personal identifying information blocked to Genetic Alliance by email at freethedata@geneticalliance.org or by facsimile at 202.966.8553.

We encourage individuals, advocacy groups, research organizations, physicians, policy groups, professional societies and industry to join the cause. For more information, please visit free-the-data.org or contact: 202.966.5557 x201.

Source: Synapse