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The Michael J. Fox Foundation Launches New Arm Of Parkinson’s Progression Markers Initiative Studying At-Risk Populations In Parkinson’s Disease

The Parkinson’s Progression Markers Initiative (PPMI), a landmark biomarker clinical study, has completed enrollment of its initial 600-member cohort of Parkinson’s patients and controls, and will launch additional study cohorts to leverage the existing PPMI infrastructure and evaluate multiple potential biomarkers for Parkinson’s disease (PD). The first of these new cohorts launches today and will investigate risk factors for PD that may enable diagnosis before the onset of motor symptoms.

The pre-motor arm of PPMI will enroll participants who do not have Parkinson’s disease but do have one of three potential risk factors for PD: a reduced sense of smell (hyposmia); rapid eye movement sleep behavior disorder (RBD); or a mutation in the LRRK2 gene (the single greatest genetic contributor to PD known to date). Research to date indicates that each of these factors can be linked to an increased risk of developing Parkinson’s disease, though many people with these conditions do not go on to develop PD. Validating these risk factors and better characterizing their connection to Parkinson’s could enable detection of the disease prior to the onset of motor symptoms and open new avenues toward identifying biomarkers — critical tools in the quest for therapies that can slow or stop disease progression.

“If scientists can learn more about the biological processes taking place in people with any of these three risk factors, we may be able to define biomarkers even before typical symptoms begin,” said Ken Marek , MD, principal investigator of PPMI and president and senior scientist at the Institute for Neurodegenerative Disorders in New Haven, Connecticut. “Finding a biomarker for PD could mean earlier diagnosis of the disease and lead to new drugs that may delay or even prevent the onset of motor symptoms.”

PPMI seeks 10,000 individuals to complete a brief online survey to determine eligibility for the loss-of-smell cohort. Participants in the other groups will largely be enrolled via research centers. This new arm will take place at 23 sites across the world where participants will undergo the same clinical assessments, imaging and collection of biospecimens as the original study.

PPMI’s open-source design and infrastructure has opened the door to evaluating multiple potential biomarkers under one umbrella, building on a precedent created by the Alzheimer’s Disease Neuroimaging Initiative (ADNI). All PPMI clinical data and characterized biosamples are available in real time, providing researchers around the world with an unprecedented resource to help speed and unify disparate biomarker validation studies. To date, 460 scientists from academia and industry have downloaded PPMI data more than 50,000 times in over 30 countries worldwide, and 21 applications have been made for use of PPMI biospecimens in biomarker research. Initial baseline data from PPMI’s original newly diagnosed and control cohorts will be presented this June at the Movement Disorders Society and is expected to be published later this year.

“Lessons learned from Alzheimer’s have taught us the importance of pursuing biomarker research concurrent with therapeutic development,” said Todd Sherer , Ph.D., CEO of The Michael J. Fox Foundation for Parkinson’s Research. “In the third year of PPMI, it is evident that a large-scale biomarker study is not only possible in Parkinson’s disease, but is already yielding scientific insights that could help transform the field’s pursuit of a cure.”

Source: PR Newswire

Better Diagnosis of Acute Heart Failure Using Pronota’s Novel Biomarker

Two independent validation studies demonstrate that Pronota’s biomarker CD146 significantly improves the diagnosis of acute heart failure for patients with shortness of breath. The biomarker, measured in blood, provides clinicians with unique additional information allowing better treatment of this challenging group of patients.

Current diagnosis for acute heart failure is limited

Current clinical practice for triaging patients with shortness of breath includes the measurement of specific peptides (B-type natriuretic peptides: BNP or NT-proBNP). Despite the widespread use of these biomarkers, there is still much room for improvement. “Natriuretic peptides have become standard tools to support making the correct diagnosis in patients with shortness of breath. However, clinicians clearly recognize the limitations of natriuretic peptides. The potential value of another biomarker to improve the diagnostic accuracy of BNP or NT-proBNP is considerable,” commented Prof. J. Januzzi (Massachusetts General Hospital, Harvard Medical School).

Pronota’s novel heart failure marker for accurate diagnosis

Pronota identified the biomarker CD146 from an unbiased proteomics effort. Its performance has now been confirmed in two independent studies totaling over 500 patients. Prof. A. Mebazaa (INSERM, Paris, France), principal investigator for the validation studies, commented: “It is exciting to see that novel biomarkers with underlying biological processes completely different from currently used biomarkers can still be discovered and validated. This not only provides more insight into the underlying disease mechanism, it also gives the physician tools to improve the management and care of heart failure patients. Pronota’s approach in this respect is unique and has proven to deliver on numerous occasions.”

Launch forecast: 2014

“Data from early verification and marker characterization studies were already highly exciting, but the recent independent validation studies exceeded our expectations and would not have been possible without the support of our network of key opinion leaders in the field” commented Katleen Verleysen, CEO of Pronota NV. “We anticipate launching this product in 2014, so that clinicians may get access to the tools they need to improve the treatment and care of their patients.”

Source: Pronota

Oxford Cancer Biomarkers Announces Biomarker Discovery Deal with AstraZeneca

Oxford Cancer Biomarkers Ltd (OCB), the UK-based company developing tests that allow medicines to be personalised for the benefit of the cancer patient, recently announced an agreement with AstraZeneca for biomarker discovery, with the potential for further collaboration on validation and development of resulting biomarkers.

OCB will work with an undisclosed AstraZeneca cancer drug to discover biomarkers that have the potential to predict responders and non-responders to the drug. Under the agreement, AstraZeneca has been granted an option to license biomarkers from the programme.

Nick McCooke, CEO of Oxford Cancer Biomarkers, commented: “The discovery and development of biomarkers of drug response is becoming an essential component of cancer drug development and commercialisation. With more targeted treatments being made available for more defined patient populations, the need for companion diagnostics is growing. We are a young company but already making a name for ourselves in the cancer biomarkers space, and we are delighted to be working with AstraZeneca on this important program.”

Andrew Hughes, Vice President of Clinical Oncology at AstraZeneca said: “Identifying the right patients is key for the development of AstraZeneca’s targeted oncology drugs. We are excited to be working with Oxford Cancer Biomarkers to explore how their novel approaches can contribute to our biomarker strategy in the early stages of drug development.”

Oxford Cancer Biomarkers uses its proprietary platform CancerNav® to rapidly generate predictive biomarkers for cancer drugs. It has successfully proven its platform through from biomarker discovery to clinical validation.

The company was founded by Nick La Thangue, Ph.D., Chair of Cancer Biology at Oxford University and David Kerr, CBE, D.Sc., M.D. FMedSci, Professor of Cancer Medicine at Oxford University. Its major investor is Quintiles with whom it also has a strategic relationship
in the biomarker space.

Source: AstraZeneca

Low Levels of Serum Bilirubin Spell Higher Lung Cancer Risk for Male Smokers

Elevated levels of bilirubin in the blood get attention in the clinic because they often indicate that something has gone wrong with the liver. Now researchers have found that male smokers with low levels of the yellow-tinged chemical are at higher risk for lung cancer and dying from the disease.

A team led by researchers at The University of Texas MD Anderson Cancer Center reported its findings in a late-breaking abstract at the AACR Annual Meeting 2013 in Washington, D.C.

“Our study indicates male smokers with low levels of bilirubin are a high-risk group that can be targeted with smoking cessation help, low-dose spiral CT screening of their lungs and other preventive measures,” said senior author Xifeng Wu, M.D., Ph.D., professor and chair of MD Anderson’s Department of Epidemiology and the Betty B. Marcus Chair in Cancer Prevention.

Lung cancer usually is diagnosed at a late stage, when tumors are inoperable and treatments largely ineffective. The overall five-year survival rate is 15 percent, but it falls to 5 percent for stage 3 lung cancer patients and 1 percent for those with stage 4 disease.

Spiral CT scans catch cancer early, biomarker could reduce false positives

The National Lung Screening Trial found that low-dose spiral computed tomography screening reduces mortality among heavy smokers by 20 percent. However, 95 percent of growths found by spiral CT are false positives, a barrier to large-scale screening.

“Validated biomarkers are urgently needed to improve risk prediction for lung cancer and to reduce false positives, shifting the balance toward more effective and efficient CT screening for cancer detection,” Wu said.

The researchers started with an objective analysis of levels of metabolites — substances produced during metabolism. Bilirubin is produced during the breakdown of old blood cells.

They analyzed 60 samples divided into three groups known as “trios” — normal controls, early stage and late stage non-small cell lung cancer patients. The top three metabolites were validated in two more groups of 50 and 123 trios.

When bilirubin emerged as the most significant metabolite, another validation study was done in a prospective cohort of 435,985 people with 208,233 men in Taiwan.

Men were divided into four groups according to their serum bilirubin levels. Lower bilirubin level was associated with significantly higher rates of both lung cancer incidence and mortality.

In the Taiwanese cohort, the incidence rate per 10,000 person-years in men was 7.02 for those in the lowest bilirubin quartile (.68 mg/dL or less), compared to 3.73 in the highest quartile of bilirubin level (1.12 mg/dL or more). The mortality rate per 10,000 person-years was 4.84 for the lowest level compared with 2.46 in the highest bilirubin quartile.

Next step: Establish a risk prediction model in heavy smokers

Bilirubin makes sense as a protective agent because of its anti-oxidant, anti-inflammatory and anti-proliferative effects. “It’s plausible that bilirubin protects against lung cancer by scavenging free radicals and carcinogens associated with smoking,” said study presenter Fanmao Zhang, a doctoral candidate in epidemiology.

Indeed, a Belgian study showed that bilirubin in the high normal range lowered cancer mortality in men. A study in the United Kingdom showed higher bilirubin levels in the normal range were associated with lower risks of chronic obstructive pulmonary disease, lung cancer and all-cause mortality. Neither of those studies stratified their analysis of bilirubin by smoking status.

“We expected that bilirubin might be protective, but our finding that bilirubin levels affect only smokers was somewhat of a surprise,” Wu said. “Our discovery that low levels increase lung cancer risk is unique.”

Smokers in the two middle cohorts of bilirubin levels also had higher lung cancer risk than those in the highest quartile. As an objective risk index for lung cancer and all-cause mortality, low levels of bilirubin should send an urgent message to quit smoking, said Chi Pang Wen, M.D., Ph.D., co-lead author from National Health Research Institutes, Taiwan.

The next step, Wu said, is to evaluate the predictive value of serum bilirubin in heavy smokers and to establish a risk prediction model that incorporates bilirubin and other biomarkers with clinical and epidemiological data to improve the efficiency of lung cancer risk prediction.

Source: EurekAlert!

Matrix-Bio Signs Metabolomics Biomarker Licensing Agreement with Quest Diagnostics for Development of Breast Cancer Recurrence Test

Matrix-Bio Inc., a diagnostics company that uses metabolite profiling to detect cancer and other diseases, recently signed an exclusive global licensing and marketing agreement for metabolomic biomarkers with Quest Diagnostics (NYSE: DGX).