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Biocept to Collaborate on Biopharma Company Clinical Trial by Identifying Biomarkers Found in Cerebral Spinal Fluid for Patients with Lung Cancer that has Spread to the Brain

Biocept, Inc. (NASDAQ: BIOC), a molecular diagnostics company commercializing and developing liquid biopsies to improve the detection and treatment of cancer, announces a collaboration on a biopharmaceutical company clinical trial analyzing biomarkers using both circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) from cerebrospinal fluid (CSF). The trial is being conducted in patients with non-small cell lung cancer (NSCLC) whose disease has spread to the brain or membranes surrounding the brain and spinal cord, known as leptomeningeal disease.

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)

Atrophy in Key Region of Brain Associated with Multiple Sclerosis

Magnetic resonance imaging (MRI) measurements of atrophy in an important area of the brain are an accurate predictor of multiple sclerosis (MS), according to a new study published online in the journal Radiology. According to the researchers, these atrophy measurements offer an improvement over current methods for evaluating patients at risk for MS.

MS develops as the body’s immune system attacks and damages myelin, the protective layer of fatty tissue that surrounds nerve cells within the brain and spinal cord. Symptoms include visual disturbances, muscle weakness and trouble with coordination and balance. People with severe cases can lose the ability to speak or walk.

Approximately 85 percent of people with MS suffer an initial, short-term neurological episode known as clinically isolated syndrome (CIS). A definitive MS diagnosis is based on a combination of factors, including medical history, neurological exams, development of a second clinical attack and detection of new and enlarging lesions with contrast-enhanced or T2-weighted MRI.

“For some time we’ve been trying to understand MRI biomarkers that predict MS development from the first onset of the disease,” said Robert Zivadinov, M.D., Ph.D., FAAN, from the Buffalo Neuroimaging Analysis Center of the University at Buffalo in Buffalo, N.Y. “In the last couple of years, research has become much more focused on the thalamus.”

The thalamus is a structure of gray matter deep within the brain that acts as a kind of relay center for nervous impulses. Recent studies found atrophy of the thalamus in all different MS disease types and detected thalamic volume loss in pediatric MS patients.

“Thalamic atrophy may become a hallmark of how we look at the disease and how we develop drugs to treat it,” Dr. Zivadinov said.

For this study, Dr. Zivadinov and colleagues investigated the association between the development of thalamic atrophy and conversion to clinically definite MS.

“One of the most important reasons for the study was to understand which regions of the brain are most predictive of a second clinical attack,” he said. “No one has really looked at this over the long term in a clinical trial.”

The researchers used contrast-enhanced MRI for initial assessment of 216 CIS patients. They performed follow-up scans at six months, one year and two years. Over two years, 92 of 216 patients, or 42.6 percent, converted to clinically definite MS. Decreases in thalamic volume and increase in lateral ventricle volumes were the only MRI measures independently associated with the development of clinically definite MS.

“First, these results show that atrophy of the thalamus is associated with MS,” Dr. Zivadinov said. “Second, they show that thalamic atrophy is a better predictor of clinically definite MS than accumulation of T2-weighted and contrast-enhanced lesions.”

The findings suggest that measurement of thalamic atrophy and increase in ventricular size may help identify patients at high risk for conversion to clinically definite MS in future clinical trials involving CIS patients.

“Thalamic atrophy is an ideal MRI biomarker because it’s detectable at very early stage,” Dr. Zivadinov said. “It has very good predictive value, and you will see it used more and more in the future.”

The research team continues to follow the study group, with plans to publish results from the four-year follow-up next summer. They are also trying to learn more about the physiology of the thalamic involvement in MS.

“The next step is to look at where the lesions develop over two years with respect to the location of the atrophy,” Dr. Zivadinov said. “Thalamic atrophy cannot be explained entirely by accumulation of lesions; there must be an independent component that leads to loss of thalamus.”

MS affects more than 2 million people worldwide, according to the Multiple Sclerosis International Foundation. There is no cure, but early diagnosis and treatment can slow development of the disease.

Source: Thalamic Atrophy is Associated with Development of Clinically Definite Multiple Sclerosis

Source: EurekAlert!

Orion Bionetworks: Developing Predictive Models to Power the Search for Cures

Today we announce the launch of Orion Bionetworks, a multi-institution cooperative non-profit alliance that is unlocking the power of shared data and predictive modeling to help transform our understanding of diseases such as multiple sclerosis (MS) and accelerate the search for cures. Alliance partners include leading organizations in patient care, computational modeling, translational research, and patient advocacy: Accelerated Cure Project for Multiple Sclerosis, the Institute for Neurosciences at Brigham and Women’s Hospital, GNS Healthcare, MetaCell, and PatientsLikeMe. Janssen Research & Development, LLC, a New Jersey-based pharmaceutical company, has provided a $5.4 million scientific sponsorship as part of its Healthy Minds program for the initial phase of this effort.

Orion Bionetworks has been established as a program of the Marin Community Foundation. Its President & CEO, Thomas Peters, Ph.D., hailed the formation of the new alliance. “We are enormously proud to welcome Orion Bionetworks within the Foundation,” said Peters. “We are confident that this blend of expertise and creativity will lead to significant scientific success.”

Key supporting partners include One Mind for Research, Morrison & Foerster, Recombinant Data, and Weber Shandwick.

A Unique Cooperative Alliance

Through Orion Bionetworks, alliance partners contribute to a communal body of knowledge in the pursuit of better disease understanding, prevention and treatment, and gain access to state-of-the-art analytical tools, technologies and inter-disciplinary expertise.

Initially, Orion Bionetworks will focus on integrating clinical, biomarker and imaging data with rich real-world patient data from existing, independent databases of over 7,000 people with MS into a causal computational disease model.

PatientsLikeMe Co-Founder and Chairman Jamie Heywood said, “This silo-breaking initiative allows data from disparate sources, including our patient network of thousands of individuals who monitor their health and share their MS symptom and treatment information, to be analyzed in a way that will transform future discoveries and maximize the benefit for all.”

Computational Modeling

Computational modeling, or biosimulation, is an emerging research platform that has the potential to transform our understanding of human biology and predict which individual or environmental factors influence the development and progression of disease. Application of sophisticated modeling and simulation technologies for drug discovery and development could help the healthcare industry overcome the current economic and product pipeline challenges it faces in a number of therapeutic areas including neuroscience.

Orion Bionetworks is creating a framework to advance causal disease models by supporting the creation of new computational tools and communities and facilitating their access to integrated, large-scale, diverse biological and clinical data from registries and repositories.

“By bringing together this multidisciplinary group of collaborators and enabling the sharing of integrated clinical and ‘omics data, Orion Bionetworks could help realize the promise of computational modeling in disease research,” said Iya Khalil, Executive Vice President and Co-Founder of GNS Healthcare, one of the alliance members. “Causal models learned directly from data will help us understand the biology of the disease and predict which approach to treatment will work for individual patients. This could accelerate the search for cures.”

Advancing Understanding of Multiple Sclerosis

Orion Bionetworks’ initial focus is multiple sclerosis. MS affects over 2.5 million individuals worldwide. It is an exceedingly complex spectrum of diseases that involves both acute inflammation and chronic, progressive neurodegeneration in the brain and spinal cord. Physicians are challenged with managing patients whose course ranges from mild disease with modest levels of disability to a small number of treatment-refractory cases with profound disability. Currently, no one can predict an individual patient’s course or whether they will respond to a prescribed therapy. Further, while we can suppress the inflammatory component of MS to some extent, there is no treatment for its neurodegenerative component and no treatment that cures a patient. Thus, this unpredictable illness takes a tremendous toll on patients and their families. However, with recent advances in biomedical science and analytic methods, MS is uniquely ready for the new tools of predictive modeling, which can integrate diverse datasets and answer critical questions beyond the reach of individual research efforts.

“The path forward is clear: through Orion Bionetworks, one large dataset of patients can be explored very deeply with all available platforms to create a reference atlas of MS,” said Philip De Jager, MD, PhD, a physician researcher at the Institute for Neurosciences at Brigham and Women’s Hospital. “With such an atlas of MS, we can chart a route forward towards the personalization of MS care and the targeting of MS-related neurodegeneration.”

Additional information on the organization and partnership opportunities is available on the organization’s website, www.orionbionetworks.org.

Source: Business Wire

New Biomarker May Help In Detecting Gliomas, Reports Neurosurgery

Researchers using sophisticated genetic testing techniques have identified a promising new biomarker for diagnosis of glioma—the most common type of malignant brain tumor, reports the January issue of Neurosurgery, official journal of the Congress of Neurological Surgeons. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.