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Novel Use of Pressure BioSciences’ Patented PCT Platform Offers New Insights into Protein Structure and Function, New Tool for Biomarker Discovery and Rational Drug Design

Last month, Pressure BioSciences, Inc. (OTCQB: PBIO) (“PBI” and the “Company”) announced that data supporting important advantages of PBI’s powerful and enabling Pressure Cycling Technology (“PCT”) platform were presented at the 27th Annual Symposium of the Protein Society held July 20-23, 2013 in Boston, Massachusetts.

The use of highly sophisticated analytical instrument systems by research scientists worldwide has resulted in a greater understanding of complex biological molecules, including proteins – the “building blocks of life.” One such instrument system, Electron Paramagnetic Resonance (“EPR”) spectroscopy, has been shown to provide key information on the structure, flexibility, and function of proteins. This information is crucial to the development of new and better diagnostics, therapeutics, and vaccines.

At this year’s annual Protein Society symposium, researchers from UCLA reported on the development of an improved EPR system based on the use of high pressure. This novel system combined (for the first time ever) two cutting-edge EPR methods: site directed spin labeling (“SDSL”) and double electron-electron resonance (“DEER”). This strategy allowed the investigation of dynamic events in proteins that would be difficult or even impossible to study by conventional EPR technology.

Dr. Wayne L. Hubbell, Distinguished Professor of Chemistry and Biochemistry and Jules Stein Professor of Ophthalmology at UCLA, and senior author of the study, commented: “The study of proteins under pressure by EPR and other spectroscopic techniques, such as Nuclear Magnetic Resonance (“NMR”), has the potential to greatly improve our understanding of the structure and function of proteins. This information could subsequently provide new insights into such important areas as biomarker discovery and rational drug design, and play an important role in the discovery process that lies ahead in the exciting field of protein science.”

Richard T. Schumacher, President and CEO of PBI, said: “We believe these and other data reported by researchers using pressure-based EPR and NMR systems strongly indicate that PCT can enhance the recovery, detection, and measurement of proteins from a wide variety of samples. In turn, this information has the potential to help accelerate the design and manufacture of new and better diagnostics, therapeutics, and vaccines. We further believe that the advantages of pressure-based spectroscopic methods are just now beginning to be realized by scientists, and that as the body of data continues to grow from high pressure-based spectroscopic studies, that PBI has the potential to become a major provider of high pressure equipment into the exciting and growing spectroscopy area.”

Source: Pressure BioSciences

Researchers Identify Biomarkers for Possible Blood Test to Predict Suicide Risk

Indiana University School of Medicine researchers have found a series of RNA biomarkers in blood that may help identify who is at risk for committing suicide.

In a study reported Aug. 20 in the advance online edition of the Nature Publishing Group journal Molecular Psychiatry, the researchers said the biomarkers were found at significantly higher levels in the blood of both bipolar disorder patients with thoughts of suicide as well in a group of people who had committed suicide.

Principal investigator Alexander B. Niculescu III, M.D., Ph.D., associate professor of psychiatry and medical neuroscience at the IU School of Medicine and attending psychiatrist and research and development investigator at the Richard L. Roudebush Veterans Affairs Medical Center in Indianapolis, said he believes the results provide a first “proof of principle” for a test that could provide an early warning of somebody being at higher risk for an impulsive suicide act.

“Suicide is a big problem in psychiatry. It’s a big problem in the civilian realm, it’s a big problem in the military realm and there are no objective markers,” said Dr. Niculescu, director of the Laboratory of Neurophenomics at the Institute of Psychiatric Research at the IU School of Medicine.

“There are people who will not reveal they are having suicidal thoughts when you ask them, who then commit it and there’s nothing you can do about it. We need better ways to identify, intervene and prevent these tragic cases,” he said.

Over a three-year period, Niculescu and his colleagues followed a large group of patients diagnosed with bipolar disorder, completing interviews and taking blood samples every three to six months. The researchers conducted a variety of analyses of the blood of a subset of participants who reported a dramatic shift from no suicidal thoughts to strong suicidal ideation. They identified differences in gene expression between the “low” and “high” states of suicidal thoughts and subjected those findings to a system of genetic and genomic analysis called Convergent Functional Genomics that identified and prioritized the best markers by cross-validation with other lines of evidence.

The researchers found that the marker SAT1 and a series of other markers provided the strongest biological “signal” associated with suicidal thoughts.

Next, to validate their findings, working with the local coroner’s office, they analyzed blood samples from suicide victims and found that some of same top markers were significantly elevated.

Finally, the researchers analyzed blood test results from two additional groups of patients and found that high blood levels of the biomarkers were correlated with future suicide-related hospitalizations, as well as hospitalizations that had occurred before the blood tests.

“This suggests that these markers reflect more than just a current state of high risk, but could be trait markers that correlate with long term risk,” said Dr. Niculescu.

Although confident in the biomarkers validity, Dr. Niculescu noted that a limitation is that the research subjects were all male.
“There could be gender differences,” he said. “We would also like to conduct more extensive, normative studies, in the population at large.”

In addition to extending the research to females to see if the same or other markers come into play, Dr. Niculescu and colleagues plan to conduct research among other groups, such as persons who have less impulsive, more deliberate and planned subtypes of suicide.

Nonetheless, Dr. Niculescu said, “These seem to be good markers for suicidal behavior in males who have bipolar mood disorders or males in the general population who commit impulsive violent suicide. In the future we want to study and assemble clinical and socio-demographic risk factors, along with our blood tests, to increase our ability to predict risk.

“Suicide is complex: in addition to psychiatric and addiction issues that make people more vulnerable, there are existential issues related to lack of satisfaction with one’s life, lack of hope for the future, not feeling needed, and cultural factors that make suicide seem like an option.”

He said he hopes such biomarkers, along with other tools, including neuropsychological tests and socio-demographic checklists currently in development by his group, ultimately can help identify people who are at risk, leading to pre-emptive intervention, counseling, and saved lives.

“Over a million people each year world-wide die from suicide and this is a preventable tragedy”.

Study: Discovery and validation of blood biomarkers for suicidality [Molecular Psychiatry]

Source: Indiana University School of Medicine

IMDEA Food and Metabolon, Inc. Announce Strategic Collaboration to Advance Nutrition-based Personalized Medicine

IMDEA Food, a Translational Research Institute from the Community of Madrid, dedicated to investigating the relationships among nutrition, food and health, and the US-based company Metabolon Inc., the pioneering leader in the field of metabolomics and molecular diagnostics serving the pharmaceutical and food industries, recently announced an ambitious collaboration program. The agreement, signed in Madrid by Dr. John Ryals, President and CEO of Metabolon, and Dr. Guillermo Reglero, Director of IMDEA Food, establishes the framework for future strategic projects aimed to develop functional foods and diagnostic tools.

Of particular interest are the prevention of prevalent chronic diseases with high societal impact, such as cardiovascular disease, cancer, obesity and neurological diseases, which are highly dependent on understanding food science and nutritional impact. To achieve this goal, individual in-depth studies to characterize the molecular mechanisms underlying the health benefits of foods and food components are needed.

“These studies promise to lead toward an efficient decrease of morbimortality due to chronic degenerative diseases and a better quality of life. IMDEA Food and Metabolon will combine their knowledge to advance towards this objective. A combined functional genomics and metabolomics approach involving complementary technologies and multidisciplinary expertise is paramount to achieve the scientific rigor and level of evidence required to bring nutrition-based personalized medicine to the public with the final objective of living longer and healthier”, commented Prof. Jose Ordovas of Tufts University, a world-renowned pioneer in nutrigenomics. Prof. Ordovas serves as the Senior Scientist and Director for the Nutrition and Genomics Laboratory and as the Chair of the Functional Genomics Core of the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University. Since its inception in 2007 Prof. Ordovas has been Chairman of the Board and Scientific Director of IMDEA Food.

The IMDEA Food Institute carries out human nutrigenomic studies, which are reviewed by a Research Ethical Committee, on its platform comprised of common services for genomics, biostatistics, bioinformatics and nutritional counseling. Metabolon is the world leader in metabolomic analysis of complex biological samples and has made major contributions to the discovery of biomarkers and biochemical pathways associated with nutrients and drugs, and which have led to the development of unique diagnostic tools. Scientists from IMDEA Food and Metabolon have met in IMDEA Food’s new headquarters located in Madrid to define the lines of common interest and greatest priority and to launch the first of a series of studies aimed at defining the molecular basis of action of key food ingredients.

Dr. Steve Watkins, Chief Technology Officer, Metabolon commented, “Collaborative studies with IMDEA will employ the combined resources and expertise of our organizations to identify appropriate biomarkers of disease risk and prevention and to monitor biological impact of nutritional components in foods. This strategic collaboration is pivotal to advancing our understanding of nutrition’s influence on health and disease.”

Source: Business Wire

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

Big Data From Alzheimer’s Disease Whole Genome Sequencing Will Be Available to Researchers Due to Novel Global Research Database

The Alzheimer’s Association and the Brin Wojcicki Foundation announced recently that massive amounts of new data have been generated by the first “Big Data” project for Alzheimer’s disease. The data will be made freely available to researchers worldwide to quickly advance Alzheimer’s science.

Discussed recently at the Alzheimer’s Association International Conference (AAIC) 2013 in Boston, the project obtained whole genome sequences on the largest cohort of individuals related to a single disease – more than 800 people enrolled in the Alzheimer’s Disease Neuroimaging Initiative (ADNI).

The genome sequencing data – estimated to be 200 terabytes – will be housed in and available through the Global Alzheimer’s Association Interactive Network (GAAIN), a planned massive network of Alzheimer’s disease research data made available by the world’s foremost Alzheimer’s researchers from their own laboratories, and which also is being publicly announced today at AAIC 2013. GAAIN is funded by an initial $5 million dollar investment by the Alzheimer’s Association, made possible due to the generous support of donors.

“The Alzheimer’s Association is committed to creating open access to research data, and we believe GAAIN will transform how neuroscience data is shared and accessed by scientists throughout the world,” said Maria Carrillo, Ph.D., Alzheimer’s Association vice president of Medical and Scientific Relations. “By fostering a higher level of global data sharing, GAAIN will accelerate investigation and discovery in Alzheimer’s through a system comparable to a search engine like Google or Bing for relevant data.”

“With the addition of more than 800 whole genomes on ADNI subjects that can be linked to the current rich dataset, ADNI data will be even more useful to scientists who are seeking new approaches to treatment and prevention of Alzheimer’s disease,” said Robert C. Green, M.D., M.P.H., of Brigham and Women’s Hospital and Harvard Medical School, who led the ADNI sequencing project. “ADNI is a leader in open data sharing, having provided clinical, imaging and biomarker data to over 4,000 qualified scientists around the world, which has generated over 700 scientific manuscripts.

First, Massive Whole Genome Sequencing Project in Alzheimer’s Disease

Whole genome sequencing determines all six billion letters in an individual’s DNA in one comprehensive analysis. The raw data from the ADNI project is being made available to qualified scientists around the globe to mine for novel targets for risk assessment, new therapies, and much-needed insight into the causes of the fatal brain disease. The new data may enable scientists to better understand how our genes cause and are affected by bodily changes associated with Alzheimer’s disease.

ADNI enrolls people with Alzheimer’s disease, mild cognitive impairment, and normal cognition who have agreed to be studied in great detail over time. The goal is to identify and understand markers of the disease in body fluids, structural changes in the brain, and measures of memory; the hope is to improve early diagnosis and accelerate the discovery of new treatments. ADNI is led by Principal Investigator Michael W. Weiner, M.D., of the University of California San Francisco and the San Francisco VA Medical Center. Dr. Green collaborated on managing the sequencing efforts with Arthur Toga, Ph.D., of UCLA and Andrew J. Saykin, Psy.D., of Indiana University. The actual genome sequencing was performed at Illumina, Inc.

ADNI is a public-private research project led by the National Institutes of Health (NIH) with private sector support through the Foundation for NIH. Launched in 2004, ADNI’s public-private funding consortium includes pharmaceutical companies, science-related businesses, and nonprofit organizations including the Alzheimer’s Association and the Northern California Institute for Research and Education.

The Global Alzheimer’s Association Interactive Network (GAAIN)

Data-sharing has already greatly benefitted scientific disciplines such as genetics, molecular biology, and the physical sciences. Data-sharing in genetics has led to dramatic advances in understanding the risk factors underlying complex diseases. The Alzheimer’s Disease Neuroimaging Initiative (ADNI) is a compelling example of dozens of geographically-dispersed researchers working together to share their data while making it freely available to others for analysis and publication.

“GAAIN is similar in spirit and goals to other ‘big data’ initiatives that seek to greatly improve the tools and techniques needed to access, organize, and make discoveries from huge volumes of digital data,” Carrillo said. “The advent of cloud computing makes it possible to link databases throughout the world and expand their data processing capability significantly to benefit the research community.”

Carrillo will supervise the development of GAAIN in conjunction with co-principal investigators Art Toga, Ph.D., of the Laboratory of Neuro Imaging (LONI) at the University of Southern California and Giovanni Frisoni, M.D., of the National Center for Alzheimer’s Disease Research and Care and the Instituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Fatebenefratelli Hospital, Italy. Enrique Castro-Leon, Ph.D., who will serve as a consultant, is an enterprise and data center architect for strategic partner Intel Digital Enterprise Group.

GAAIN is built on an international database framework already in use by thousands of scientists and local computational facilities in North America and Europe. The network makes research data available free-of-charge for searching, downloading, and processing across a cloud-based, grid-network infrastructure accessible anywhere through Internet access.

The key to GAAIN’s innovation is its federation of data, which is unprecedented for such a system. GAAIN leadership will invite scientists conducting qualified studies to become partners by permitting GAAIN to link directly to their databases. This will enable researchers to add continually to their data sets and keep all data in GAAIN current and dynamic. It also will enable the scientists to retain control over access to their data, which the Association believes will be important to encouraging participation.

“This is unprecedented and of the utmost importance in brain research, where sometimes thousands of examples are required to observe even the smallest change in the brain,” said Giovanni Frisoni, M.D., neurologist and deputy scientific director at the National Center for Alzheimer’s Disease Research and Care at the IRCCS. He will lead the work of GAAIN in Europe.

“Through GAAIN we envision combining massive amounts of data from multiple sources across many subjects participating in numerous studies,” said Art Toga, Ph.D., professor of neurology at UCLA and director of LONI. “This will provide more statistical power than ever before.”

Source: Alzheimer’s Association