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OPKO Announces Publication of ProtecT Study Using Kallikrein Biomarkers in 4Kscore Test

OPKO Health, Inc. (NYSE:OPK) recently announced the online publication of a study entitled “Predicting High-Grade Cancer at Ten-Core Prostate Biopsy Using Four Kallikrein Markers Measured in Blood in the ProtecT Study” in the Journal of the National Cancer Institute. The study shows that the four kallikrein panel of biomarkers utilized in the OPKO 4Kscore® Test (Total PSA, Free PSA, Intact PSA and hK2) accurately identifies risk for aggressive prostate cancer prior to prostate biopsy.

Study Says New Biomarker May Predict Mesothelioma Survival, According to Surviving Mesothelioma

A team of researchers at Australia’s University of New South Wales say MUC1, a glycoprotein found on the outer surface of epithelial cells, is overexpressed in peritoneal mesothelioma. MUC1 is a mucin, a type of protein that helps protect the body against infection by binding with pathogens in the extracellular space and preventing them from entering cells.

Although MUC1 overexpression can predict poor survival in most cancers, and is often used to help diagnose mesothelioma, the Australian study is the first to measure its prognostic significance in mesothelioma, a rare cancer brought on by asbestos exposure. Mesothelioma most often occurs on the membrane that lines the lungs but peritoneal mesothelioma affects the lining of the abdomen. It accounts for about 25 to 30 percent of mesothelioma cases and, like all types of mesothelioma, is usually deadly.

Of the 42 peritoneal mesothelioma patients in the new study, 38 showed overexpression of MUC1. The significance of that overexpression was measured using the Kaplan-Meier method. Mesothelioma patients with a MUC1 level (based on immunohistochemical tests) between 5 and 8 had the lowest survival in all subtypes of tumors. Of the different variables tested – including tumor subtype, patient gender, peritoneal cancer index, and age at diagnosis – only a high MUC1 level and being over 60 years old at the time of diagnosis were consistently associated with poor outcomes.

Writing on their findings in the International Journal of Biological Markers, the authors conclude, “MUC1 evaluation by immunohistochemistry may serve as a useful prognostic tool in malignant peritoneal mesothelioma, but may need further confirmation in larger patients’ cohort.” Earlier this year, the same team of researchers determined that high expression of BCL2, a protein that helps regulate cell death (apoptosis), is associated with a good prognosis for patients with peritoneal mesothelioma.

In clinical practice, biomarkers are often used to help plan a treatment strategy for mesothelioma and other hard-to-treat cancers.

The original study appears in a recent issue of the International Journal of Biological Markers. (Pillai, K, et al, “MUC1 has prognostic significance in malignant peritoneal mesothelioma”, July 4, 2013, International Journal of Biological Markers, Epub head of print. http://www.ncbi.nlm.nih.gov/pubmed/23828409)

Study: MUC1 has prognostic significance in malignant peritoneal mesothelioma [International Journal of Biological Markers]

Source: PR Web

Study Reveals Much-needed Strategy to Protect Against Deadly Liver Fibrosis

Chronic liver disease is a leading cause of death in the United States, in part because it often causes the formation of harmful scar tissue—a process known as fibrosis. A study published by Cell Press August 15 in the journal Immunity reveals the central role the immune molecule interleukin 33 (IL-33) plays in the formation of liver fibrosis. The findings suggest that drugs targeting this molecule could serve as a new treatment strategy to protect against liver fibrosis.

“Currently, the therapeutic options for liver fibrosis are limited and not curative,” says senior study author Stefan Wirtz of Friedrich-Alexander University Erlangen-Nuremberg. “We identified novel immunological factors that contribute to the development of liver fibrosis, opening up new avenues for the treatment of this serious condition.”

Liver fibrosis refers to the accumulation of harmful deposits of extracellular matrix (ECM) proteins, and it can eventually lead to organ failure. Past studies have suggested that this kind of damage is associated with abnormal immune responses in the liver, but very little was known about the molecules and cells that contribute to fibrosis.

In the new study, Wirtz and his team found that the amount of IL-33 in the blood was higher than normal in patients with liver disease. Following up on this observation, they discovered that injection of IL-33 into mice caused ECM proteins to build up in the liver, whereas mice that were genetically modified to lack IL-33 were largely protected from fibrosis. The researchers went on to identify the immune networks underlying IL-33’s harmful effects and discovered that this molecule activates immune cells called type 2 innate lymphoid cells (ILC2), which had never before been linked to liver disease.

“Our findings reveal IL-33 as a novel biomarker that could potentially lead to early detection of fibrosis in patients, which may be extremely valuable for preventing further damage to the liver,” Wirtz says. “Moreover, the study shows that drugs targeting IL-33 or ILC2 responses could be a promising strategy to protect against fibrosis and chronic liver disease.”

Study: Interleukin-33-Dependent Innate Lymphoid Cells Mediate Hepatic Fibrosis [Immunity]

Source: EurekAlert!

Two Biomarkers Predict Increased Risk for “Silent” Strokes

Two biomarkers widely being investigated as predictors of heart and vascular disease appear to indicate risk for “silent” strokes and other causes of mild brain damage that present no symptoms, report researchers from The Methodist Hospital and several other institutions in an upcoming issue of Stroke (now online).

The researchers found high blood levels of troponin T and NT-proBNP were associated with as much as 3 and 3.5 times the amount of damaged brain tissue, respectively. The findings are part of the large-scale Atherosclerosis Risk in Communities (ARIC) study, funded by the National Heart, Lung, and Blood Institute.

“The concept of prevention is expanding,” said principal investigator Christie Ballantyne, M.D., director of the Center for Cardiovascular Disease Prevention at The Methodist Hospital. “It’s not good enough to simply do a few tests and try to assess risk for heart attack. What we need to do is assess the risk for heart attack, stroke, heart failure and also asymptomatic disease so we can start preventive efforts earlier. Waiting to correct problems until after a symptomatic stroke may be too late.”

One possible outcome is that patients determined to be in high-risk groups could be started on anti-stroke medications sooner.

In another ARIC paper published two months ago in Stroke, Ballantyne and coauthors reported a strong association between blood levels of troponin T and NT-proBNP and more severe instances of stroke, called symptomatic stroke. The current study looked at the two biomarkers and “subclinical,” asymptomatic events in the brain that are usually caused by a lack of blood flow.

“Taken together, these two papers show the biomarkers are effective at identifying people who are likely to have mild brain disease and stroke well before damage is done,” said Ballantyne, who also is a Baylor College of Medicine professor. “This hopefully will give doctors more time to help patients take corrective steps to protect their brains.”

For the subclinical brain disease study, researchers gleaned data from about 1,100 patient volunteers who agreed to have blood drawn and two MRI scans eleven years apart to look for silent brain infarcts and also white matter lesions (WMLs) caused by chronic inflammation.

Statistical analysis showed a strong relationship between high NTproBNP and the likelihood of brain infarcts and WMLs. Study participants with the highest levels of NT-proBNP had as much as 3.5 times the number of brain infarcts as participants with low NT-proBNP levels, and more WMLs. Those with the highest levels of troponin T had as much as 3.0 times the number of brain infarcts and more WMLs.

The protein troponin T is part of the troponin complex and its presence is often used to diagnose recent heart attacks. NT-proBNP is an inactive peptide fragment left over from the production of brain natiuretic peptide (BNP), a small neuropeptide hormone that has been shown to have value in diagnosing recent and ongoing congestive heart failure.

“The highly sensitive troponin T test we used is not approved for general clinical use in the US yet, but the NT-proBNP test is just now starting to be used more widely beyond making a diagnosis for heart failure,” Ballantyne said.

The Center for Cardiovascular Disease Prevention is part of the Methodist DeBakey Heart & Vascular Center.

Also contributing to this study were Razvan Dadu, Salim Virani, Vijay Nambi, and Ron Hoogeveen (Baylor College of Medicine and Methodist Center for Cardiovascular Disease Prevention), Myriam Fornage and Eric Boerwinkle (University of Texas Health Sciences Center at Houston), Alvaro Alonso (University of Minnesota School of Public Health), Rebecca Gottesman (Johns Hopkins School of Medicine), and Thomas Mosley (University of Mississippi Medical Center). It was funded with grants from NHLBI and NIH, while Roche Applied Science helped fund the development of diagnostic technology.

Stroke is published by the American Heart Association and American Stroke Association.

Source: Cardiovascular Biomarkers and Subclinical Brain Disease in the Atherosclerosis Risk in Communities Study.

Source: Troponin T, N-terminal pro-B-type natriuretic peptide, and incidence of stroke: the atherosclerosis risk in communities study.

Source: The Methodist Hospital System

TGen and Riddell Announce Partnership for Biomarker Study of Concussive Injuries

Head protection plays a vital role in the health and safety of any athlete participating in helmeted sports. In a move that could help revolutionize football player safety, the Translational Genomics Research Institute (TGen), and Easton-Bell Sports through its Riddell brand, announced recently it would work together on a study designed to advance athlete concussion detection and treatment. Information gathered through the study will also be used to develop new football headgear and further refine updates to player monitoring technology.

“TGen welcomes this remarkable opportunity to join Riddell in a major research study with the goal of helping to objectively monitor a player on the field (with microelectronics combined with nucleic acid sequencing),” said Dr. Jeffrey Trent, TGen President and Research Director. “TGen’s work over the past several years in the area of head trauma is accelerating new insights to the critical study of concussion injury.”

The genesis of this potentially groundbreaking study is to merge a player’s genetic information with real-time microelectronic information captured by Riddell’s Sideline Response System (SRS). A highly sophisticated, data-intensive system, Riddell SRS provides researchers, athletic staff and players with a wide range of valuable information on the number and severity of head impacts a player receives during games and practices. Employed since 2003 by several well-respected research institutions, Riddell SRS has captured 1.8 million impacts from youth to elite football competition, and its data has led to impactful changes to rules, how the game is played and coached, and has informed new helmet designs.

“As the industry leader in football head protection, Riddell has the unique opportunity to advance TGen’s groundbreaking medical research into the brain as we work together towards identifying a way to accurately and quickly diagnose concussions in football players,” said Dan Arment, President of Riddell. “With Riddell’s commitment to player protection and history of innovation, we are hopeful that our collaboration with TGen will help us better protect athletes and lead us to meaningful advancements in helmet technology that move the game of football forward.”

A key question the study seeks to answer is: are the effects of sub-concussive hits identifiable through blood-based molecular information? “Based on our current information, we believe this study will have the unique ability to provide a molecular ‘risk’ and ‘recovery’ score, enabling physicians to better identify when a player might be expected to recover from the effects of the concussion and get back on the field,” said Dr. Kendall Van Keuren-Jensen, TGen Assistant Professor, whose technique for studying molecular information at a micro level will drive the research.

While the joint study will begin with football, the Riddell-TGen partnership has the potential to improve sports equipment manufactured by brands in the broader Easton-Bell Sports portfolio, including headgear for hockey, baseball, cycling, snowsports, and powersports. “As the awareness of head injury grows across all sports, supporting science like this will help us offer a more protective helmet solution to the athlete,” said Arment.

Local Institutes and Advocate to Join Study

As part of the study, TGen will work with the Barrow Neurological Institute whose B.R.A.I.N.S. (Barrow Resource for Acquired Injury to the Nervous System) program treats patients who have sustained a traumatic brain or spinal cord injury.

“Combining our neurological expertise and the information from our B.R.A.I.N.S. program, with TGen’s genomic knowledge and Riddell’s helmet technology, will provide great insight into how we measure concussions and how they affect the human brain,” said Dr. Javier Cárdenas, a neurologist and brain injury expert with Barrow Neurological Institute. “The genomic data could aid in the treatment process and will greatly add to the growing body of knowledge we’re acquiring about head injury patients.”

Joining Barrow will be athletic trainers from A.T. Still University and SAFE Football, which teaches alternative game-play techniques that reduce the number of head impacts while increasing competitiveness.

“Our partnerships with Barrow Neurological Institute, A.T. Still University, and Safe Football provide a multifaceted approach to identifying athletes in need of medical attention, to educating athletes on concussion and brain injury, to reducing the risk of injury through development of better techniques, and to improving treatment outcomes,” said Dr. Matt Huentelman, TGen Associate Professor and a co-investigator on the study.

Source: Translational Genomics Research Institute (TGen)