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Researchers Discover Biomarker, Potential Targeted Therapy for Pancreatic Cancer

University of Cincinnati (UC) researchers have discovered a biomarker, known as phosphatidylserine (PS), for pancreatic cancer that could be effectively targeted, creating a potential therapy for a condition that has a small survival rate.

Cardiac Biomarker ST2 Proves Far Superior To Galectin-3 In A Head-to-Head Study

Critical Diagnostics recently announced that the study, “Head-to-head comparison of two myocardial fibrosis biomarkers for long-term heart failure risk stratification: ST2 vs. Galectin-3”, recently published online in JACC (the Journal of the American College of Cardiology) comparing the company’s novel cardiac biomarker ST2 to Galectin-3 (Gal-3), a biomarker from BG Medicine (NASDAQ: BGMD), found ST2 to be superior.

As Michael J. Fox Returns to Primetime, His Research Foundation Urgently Pursues the Cure for Parkinson’s

Last month, Michael J. Fox returned to television as the star of his own sitcom after more than two decades living with Parkinson’s disease. Fox’s decision to return to primetime has injected Parkinson’s into the national conversation — a conversation already transformed by The Michael J. Fox Foundation for Parkinson’s Research (MJFF), which the actor launched in 2000 with the exclusive goal of funding research to speed a cure for the disease.

Asthmapolis Relaunches as Propeller Health to Advance Broader Respiratory Mission

Asthmapolis, the FDA-cleared mobile health solution for chronic respiratory disease, recently announced the company is changing its name to Propeller Health. The Propeller platform is designed to help patients and their physicians better understand and control respiratory disease to reduce preventable emergency room visits, hospitalizations and unnecessary suffering.

Propeller Health will now offer providers and payers expanded mobile apps for asthma, COPD and other respiratory disease, as well as new sensors for additional inhaled medications pending regulatory clearance.

“COPD is the third leading cause of death in the United States and an extremely costly disease, both in its actual medical costs and the impairments that limit patients with this illness. I believe using technology to help improve adherence and give clinicians early indications of increasing symptoms or exacerbations is valuable and will make an important contribution to helping people successfully manage the disease,” said David Mannino, MD, professor and chair, University of Kentucky Department of Preventive Medicine and Environment, and international expert on the epidemiology and impact of COPD.

Early outcomes have been promising. In the last month, more than two-thirds of Propeller users with asthma were well-controlled or transitioned to well-controlled; by comparison, only 30-40 percent of the general population with asthma has their disease under control. In recent programs, up to 80 percent of patients with asthma remain engaged with Propeller three to six months after enrollment. As a result, the Propeller platform has yielded an 80 percent improvement in medication adherence.

“We need to be doing everything we can to help people manage their health conditions and prevent unnecessary trips to the hospital,” said Rich Roth, vice president of strategic innovation at Dignity Health. “Propeller Health is in a position to make big difference for our patients, which is why we’re excited to see the company moving in this direction.”

Propeller is a novel combination of snap-on sensors, mobile apps, analytics and personal services to empower people to achieve better self-management of their respiratory disease, while reducing the burden of chronic disease management. The HIPAA-compliant solution uses remote monitoring to track when and how often patients use their inhaled medications. This real-time information advances understanding of symptoms and triggers and reveals insights about both medication adherence and rescue medication frequency. Analytics coupled with personalized feedback and individual support, including access to health educators and community managers, inform more productive conversations between Propeller users and their care teams, contributing to positive behavior change, improved quality of life and reduced costs to manage chronic disease like asthma and COPD.

“Over the last year, we’ve grown to be the leading mobile health platform for managing asthma. Today we are charting a new course in chronic respiratory disease management, applying our proven technology and accumulated wisdom to reduce healthcare utilization for COPD,” said David Van Sickle, CEO of Propeller Health. “The Propeller brand broadens our mobile health footprint to include all disease treated with inhaled medications. It more accurately describes how we use technology to achieve momentum in self-management, but with minimal disruption to our users’ daily lives, which in turn helps improve outcomes that reduce cost.”

“Asthmapolis, now Propeller Health, is one of the leaders in mobile health sensors and apps. It is great to see their expansion from asthma to COPD,” said Eric Topol MD, CAO of Scripps Health and author of The Creative Destruction of Medicine (Topol has no relationship with the company). “Further, someday in the future there is now hope that such a platform will be able to markedly reduce asthma attacks and exacerbations of COPD.”

Propeller for COPD is available now, and the company is filing applications for international regulatory clearance for additional sensors later this year.

Source: Propeller Health

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