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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

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

First Test to Objectively Diagnose Fibromyalgia Now Available

A recent peer-reviewed study, published in BMC Clinical Pathology,[1] reveals a medical breakthrough discovering multiple biomarkers based upon highly sensitive and reproducible medical investigations. Conducted by the University of Illinois College of Medicine at Chicago (UIC) and EpicGenetics, a privately-held biomedical company, the research has led to the development of The FM/a® Test (www.thefmtest.com), the first test to objectively diagnose fibromyalgia.

Researchers at the UIC Department of Pathology conducted a statistically significant study involving more than 200 patients, comparing those clinically diagnosed with fibromyalgia to healthy patients. The study revealed that patients with fibromyalgia have a dysregulation disorder affecting protein molecules called chemokines and cytokines, produced by white blood cells. While fibromyalgia patients have been classified to be hyperactive (or overactive) responders, the study showed that people with fibromyalgia have immune production patterns which may make them more vulnerable to stress, thereby leading to chronic pain, severe fatigue, diffuse muscle tenderness, insomnia, and other unbearable symptoms long associated with fibromyalgia. Evaluation of The FM Test patient results will provide a continuing database that could lead to further insight into what may cause and exacerbate fibromyalgia and permit the development of standards to determine effective treatments.

EpicGenetics worked with fibromyalgia support groups to recruit participants in the clinical research study and is collaborating with groups such as the National Fibromyalgia & Chronic Pain Association to educate the fibromyalgia community and others about the availability of The FM Test.

“The results of our research have allowed us to ‘pull back the curtain’ and identify specific diagnostic biomarkers in fibromyalgia,” said Bruce S. Gillis, MD, MPH, member of the clinical faculty at the UIC College of Medicine and founder of EpicGenetics. “For decades, the medical community has viewed fibromyalgia with much skepticism. Patients have been stigmatized, and many are spending thousands of dollars and years of frustration in search of a diagnosis. Our breakthrough provides patients with hope and validation that their symptoms are real, and we hope physicians who commonly see patients with fibromyalgia will embrace and value this test for its role in the advancement of medical care.”

According to the American College of Rheumatology, fibromyalgia affects more than 12.3 million people in the United States, comparable to the number of people affected by cancer. Patients who experience symptoms, such as chronic pain and fatigue, depression and insomnia, spend an average of three to five painful years seeking a diagnosis and $4,800-$9,300 annually on associated medical costs. Until now, there has been no conclusive test to confirm the diagnosis of fibromyalgia.

The FM Test, a simple blood test with more than 93 percent sensitivity, now makes it possible for anyone to find out if they have fibromyalgia. The FM Test costs $744 with conclusive results available to most patients usually in a week or less – a fraction of the time and money the average patient currently spends seeking a diagnosis.

By completing a simple symptoms questionnaire at www.thefmtest.com, patients and their doctors can find out if they qualify for the test. If a patient meets the requirements, they can arrange for the test at their doctor’s office or at an independent blood draw facility.

“The elegantly designed study by Dr. Gillis and his co-investigators represents a milestone on the path our group charted 25 years ago when we first hypothesized that cytokines play a role in fibromyalgia2. It is hoped that this and future work sponsored by EpicGenetics will lead to a greater understanding of how the immune system, fatigue, sleep disorders, chronic stress and pain interact in patients with fibromyalgia and related disorders,” said Daniel J. Wallace MD, FACP, FACR, a clinical professor of medicine at the David Geffen School of Medicine at UCLA based at Cedars-Sinai Medical Center, and a member of the Scientific Advisory Board of EpicGenetics.

Source: Business Wire

Caris Life Sciences Adds Next-Generation Sequencing to Enhance Evidence-Based Tumor Profiling Service for Cancer Patients

Caris Life Sciences®, a leading biosciences company focused on fulfilling the promise of personalized medicine, recently announced the commercial availability of mutational analysis by Next-Generation Sequencing (NGS), which will replace its former mutational analysis platform. NGS joins an extensive collection of tumor profiling technologies currently employed by Caris Molecular Intelligence(TM) Service (MI Profile(TM)), including Immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), chromogenic in situ hybridization (CISH), restriction fragment length polymorphism (RFLP) and polymerase chain reaction (PCR), providing oncologists the most comprehensive molecular profiling capabilities commercially available today.

MI Profile(TM) offers comprehensive tumor biomarker analyses coupled with an extensive clinical literature evidence review, which matches potential therapies to patient-specific biomarker information. Oncologists are provided simple-to-read reports indicating which available chemotherapeutic, biologic and hormone therapies are potentially effective, along with those that are potentially less effective, based on the molecular profiling results. The report further provides information on appropriate and enrolling clinical trials for the patient. This service presents clinically-relevant, patient-specific information doctors can use to individualize cancer treatment.

Unlike other tumor profiling services on the market, which are often powered by a single technology platform, or hinge on the successful exploitation of a particular DNA mutation, Caris remains both technology- and biomarker-agnostic, employing a wide range of technologies to uncover a broad array of key biomarkers. With this unique approach, the company currently reports potentially clinically-relevant biomarker to drug associations in approximately 95 percent of patient cases, averaging more than 25 possible clinically-actionable biomarkers per patient.

“Evaluating DNA only doesn’t address the true complexity of the biology driving the cancer. It is essential to consider the significant impact of RNA and downstream alterations of the proteins involved in each patient’s disease,” said David D. Halbert, Chairman and Chief Executive Officer of Caris Life Sciences. “It’s imperative to perform a holistic and comprehensive analysis on a tumor, especially the proteins, which are the active agents. Anything less does a disservice to the treating physician and could potentially put a patient at risk.”

“Integrating next-generation sequencing further demonstrates our commitment to continually evolve with emerging science to provide our physicians with an unmatched comprehensive tumor profiling service,” said Tom Spalding, Senior Vice President & Group Head, Oncology, Caris Life Sciences. “As a result of this comprehensive approach, we believe we can provide significantly greater clinical utility than services that solely rely on single technology platforms. For example, NGS analysis alone would not provide oncologists with key insights into some of the most commonly used companion diagnostics, as FDA-approved labeling requires the use of specific and varied profiling technologies.”

NGS will power the mutational analyses performed in the company’s Select and Comprehensive profiles, enabling rapid examination and broader detection of somatic mutations across hundreds of hotspots in the cancer genome. Additionally, this critical technology enables the inclusion of emerging biomarkers that may have potential clinical or research applications. The addition of these emerging biomarkers will further enhance the utility of the Caris Registry®, which houses critical data on biomarker, drug and patient outcomes that may yield greater insights into the treatment of various cancers.

“From both breadth of information and research utility perspectives, NGS is most valuable when combined with other technologies like IHC and FISH to more comprehensively assess a patient’s tumor,”said Sandeep Reddy, M.D., Clinical Professor of Medicine at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA) and Senior Medical Director at Caris Life Sciences. “Sequencing alone may provide relevant results in smaller percentages of cancer patients, giving the treating physician only part of the full molecular picture. In contrast, Caris provides more meaningful biomarker analysis and delivershighly thorough interrogation of important biomarkers in the cancer pathway. Additionally, Caris’ approach also allows for compliance with FDA labeling on approved companion diagnostics.”

With more than 45,000 patients profiled to date, Caris Life Sciences houses the most comprehensive collection of biomarker profiles in the industry today. Beyond obvious research implications, this extensive database provides clinicians with critical information about the prevalence of biomarkers in unexpected disease states, allowing them to select personalized, tailored therapy regimens for their patients.

Source: Caris Life Sciences

UCLA Dentistry Receives Major Grant to Develop Saliva Test to Predict Onset of PTSD

Each year, more than a million Americans are at-risk of developing serious mental health problems after experiencing a terrifying event or serious physical injury. Once manifested, these psychiatric illnesses, such as post-traumatic stress disorder and depression, can be extremely crippling and difficult to treat and are a leading cause of disability in civilian, military and minority populations.

Recognizing these emerging disorders early on provides health care professionals the best opportunity for preventive interventions. Now, a team of researchers, led by Dr. Vivek Shetty, a professor at the UCLA School of Dentistry, has received a $3.8 million research grant to develop a salivary-biomarker approach for identifying individuals at future risk of developing post-traumatic stress disorder and depression following a traumatic event.