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Inventages Portfolio Company, Cognoptix, Demonstrates the Ability to Accurately Identify Alzheimer’s Disease

Inventages announces that one of its portfolio companies, Cognoptix, has demonstrated unprecedented accuracy in detecting Alzheimer’s disease. A multi-site clinical trial of the SAPPHIRE II eye test showed a sensitivity of 85% and a specificity of 95% in differentiating Alzheimer’s disease patients from healthy volunteers.

Florida Hospital Collaborates with VTT of Finland to Explore Research for Early Detection of Alzheimer’s Disease

Scientists from VTT and the University of Eastern Finland recently teamed up to discover a serum biochemical signature which predicts progression to Alzheimer’s disease. From this, VTT was able to develop a biomarker assay. Florida Hospital and VTT have since come together to evaluate screening, diagnostic and prognostic potential of the biomarker essay.

KineMed Awarded NIH Contract to Identify Biomarkers for Myocardial Fibrosis

KineMed, Inc. (www.kinemed.com) recently announced that the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH), awarded the company a Phase I SBIR (Small Business Innovation Research) contract to develop biomarkers for the detection of early myocardial fibrosis. Biomarkers for myocardial fibrosis will guide disease interventions that block the progression of this disease which is risk factor for heart failure and arrhythmias.

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

Researchers to Identify Genetic Biomarkers for Aggressive Breast Cancer

The Avon Foundation for Women recently awarded a $300,000 grant to Dolores Di Vizio, MD, PhD, associate professor in the Department of Surgery and the Department of Pathology and Laboratory Medicine and a member of the Cancer Biology and Urologic Oncology Research Programs at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute to advance scientific research in aggressive breast cancer.

Di Vizio will collaborate with the Cedars-Sinai Women’s Cancer Program to investigate biomarkers in patient blood samples that may identify individuals with aggressive breast cancer. Biomarkers are genes or other molecules that can indicate a person’s predisposition to specific medical conditions.

Research findings have the potential to create a novel standard of care and a new source of biomarkers. The possible new source of biomarkers, known as large oncosomes, are tumor-derived vesicles that transmit signaling complexes between cell compartments, providing valuable insight into the progression of disease. Findings may also help researchers and clinicians predict the aggressiveness of breast cancer earlier in the diagnostic process.

“This kind of research is the essential foundation to get us to our real goal, which is to improve diagnostic and prognostic capabilities and find effective treatments for breast cancer,” said Di Vizio. “With this study, we hope to identify previously unrecognized large oncosomes as potential biomarkers in advanced tumors that can be visualized, quantified and isolated using methods easily translatable to the clinic.”

Funding from the Avon Foundation for Women, a nonprofit organization and longtime supporter of Cedars-Sinai, will provide an opportunity for researchers to further spearhead new technologies, therapies and surgical interventions that may provide better patient outcomes, beginning at diagnosis.

Working with Di Vizio to provide these advancements is collaborator Beth Y. Karlan, MD, director of the Women’s Cancer Program, director of the Division of Gynecologic Oncology in the Department of Obstetrics and Gynecology, the Cedars-Sinai Board of Governors Chair in Gynecologic Oncology and the director of the Cedars-Sinai Gilda Radner Hereditary Cancer Program.

“I’m excited to be a collaborator on this research study, as it holds promise to provide tangible improvements in earlier diagnostics and detection in aggressive breast cancer and is perfectly aligned with the program goals of the Cedars-Sinai Women’s Cancer Program,” said Karlan. “This Avon Foundation for Women grant will further our program’s commitment to studying cancer biology, developing new approaches to early detection and preventing and improving cancer survival for all patients.”

This is the first study on large oncosomes analyses in patients with breast cancer. Pilot funding for this grant is supported by the Martz Breast Cancer Discovery Fund.

Source: EurekAlert!