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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)

Lilly Acquires Novel Tau Tangle Diagnostic Program to Bolster Alzheimer’s Disease Research and Development

Eli Lilly and Company (NYSE: LLY) recently announced it has acquired two investigational positron emission tomography (PET) tracers from Siemens Medical Solutions USA, Inc. The tracers are intended to image tau (or neurofibrillary) tangles in the brain, one of two known hallmarks of Alzheimer’s disease. Based on studies of samples obtained at autopsy, the amount and location of tau tangles in an Alzheimer’s disease patient’s brain is thought to correlate with the severity of the disease. There are currently no approved diagnostics to detect tau tangles in living patients, creating challenges for scientists working to understand the progression of the disease and how therapies may impact it.

Lilly will initially focus on incorporating this new technology into its anti-amyloid and anti-tau research and development (R&D) programs. Use of a tau tangle tracer could enable tailoring and early identification of at-risk patients, as well as potentially provide a marker for treatment response. Lilly also has the option to commercialize the tracers. The tracers will be developed and validated by a team at Avid Radiopharmaceuticals, Lilly’s wholly owned subsidiary focused on molecular imaging. Financial terms of the deal are not being disclosed.

“The acquisition of these tau tangle tracers builds on our 25-year commitment of investing in Alzheimer’s disease research and development to bring new medicines to patients facing the terrible consequences of Alzheimer’s disease,” said Jan M. Lundberg, Ph.D., executive vice president, science and technology, and president, Lilly Research Laboratories. “We are hopeful that this technology will both enhance our understanding of tau and its role in Alzheimer’s disease, and contribute to the development of our anti-amyloid and anti-tau based therapies to treat this disease.”

“PET imaging is a valuable tool in the fight against Alzheimer’s disease, and Siemens is committed to helping fight this growing threat to our aging population,” said James Williams, CEO, Siemens Molecular Imaging business unit. “Lilly’s continued development of these tau PET tracers combined with Siemens’ ongoing investment in innovative PET imaging solutions is another great example of how Siemens is collaborating with pharmaceutical companies in an effort to provide new hope to patients and their families.”

There are two defining pathologies linked to the development of Alzheimer’s disease: the accumulation of amyloid-beta protein that forms beta-amyloid plaques outside of neurons, and the accumulation of tau protein that forms tau tangles inside them.The formation of tau tangles is thought to block the transport of nutrients and essential molecules throughout the cell, leading to neurodegeneration, or the progressive loss of structure or function of neurons. The formation of tau tangles mostly occurs after beta-amyloid plaques have developed, but unlike beta-amyloid plaques the evolution of tau tangle pathology is believed to closely mirror cognitive decline.

Scientists theorize that both beta-amyloid plaques and tau tangles are required for the development of Alzheimer’s disease, with the accumulation of amyloid beta representing the early trigger that initiates the disease process and tau tangles playing a secondary but critical role in the process of neuronal toxicity and death. For this reason, Lilly has established R&D programs to explore both the amyloid and tau hypotheses. Today’s acquisition will inform and help progress Lilly’s multiple approaches to treating Alzheimer’s disease, with the goal of speeding innovation to patients worldwide.

Source: Eli Lilly

Roche and Isis Pharmaceuticals Form Alliance for Huntington’s Disease

Roche (SIX: RO, ROG; OTCQX: RHHBY) and Isis Pharmaceuticals, Inc (NASDAQ: ISIS) recently announced that they have formed an alliance to develop treatments for Huntington’s disease (HD) based on Isis’ antisense oligonucleotide (ASO) technology. This alliance combines Isis’ antisense expertise with Roche’s scientific expertise in developing neurodegenerative therapeutics. In addition, Isis and Roche will be collaborating to combine Isis’ ASOs and Roche’s proprietary “brain shuttle” program with the objective of increasing the brain penetration of ASOs with systemic administration.

Huntington’s disease is an inherited genetic brain disorder that results in the progressive loss of both mental faculties and physical control. Symptoms usually appear between the ages of 30 to 50, and worsen over a 10 to 25 year period. Ultimately, the weakened individual succumbs to pneumonia, heart failure or other complications. Presently, there is no effective treatment or cure for the disease, and current treatments focus on reducing the severity of some disease symptoms.

Initially, research will focus on Isis’ lead drug candidate that blocks production of all forms of the huntingtin (HTT) protein, the protein responsible for HD and thus has the potential to treat all HD patients. Isis is also conducting research into treatments that specifically block production of the disease-causing forms of the HTT protein which has the potential to treat subsets of HD patients. In parallel, Roche will combine its proprietary brain shuttle technology with Isis ASO technology that, if successful, will also allow systemic administration of antisense drugs to treat asymptomatic patients.

Under the terms of the agreement, Roche will make an upfront payment of $30 million to Isis, with total payments related to license fee and pre- and post-licensing milestone payments reaching potentially $362 million, including up to $80 million in potential commercial milestone payments. In addition, Isis will receive tiered royalties on sales of the drugs. Roche has the option to license the drugs from Isis through the completion of the first Phase 1 trial. Prior to option exercise, Isis is responsible for the discovery and development of an antisense drug targeting HTT protein. Roche and Isis will work collaboratively on the discovery of an antisense drug utilizing Roche’s “brain shuttle” program. If Roche exercises its option, it will be responsible for global development, regulatory and commercialization activities for all drugs arising out of the collaboration.

Commenting on the deal, Luca Santarelli, Head of Neuroscience and Small Molecules Research at Roche, said: “Huntington’s is a severely debilitating neurodegenerative disease and a large unmet medical need. Patients experience gradually worsening motor function and psychological disturbances, with a significant shortening of life expectancy after the disease is diagnosed. Treatments are urgently needed, and we believe that the Isis approach in combination with Roche’s brain shuttle represent one of the most advanced programs targeting the cause of HD with the aim of slowing down or halting the progression of this disease.”

Shafique Virani, Global Head Neuroscience, Cardiovascular & Metabolism at Roche Partnering, added: “Central to the partnership is Roche’s brain shuttle program, which we see as highly complementary to Isis’ drug development work. This dual track development program ensures whichever candidate compound proves to be most promising — Isis’ lead target or Roche’s brain shuttle version — can be taken forward to pivotal clinical trials.”

“We are pleased to be working with Roche, a global leader in drug development with significant experience in developing and commercializing drugs to treat neurological diseases. We believe that Roche’s expertise in developing CNS drugs, along with their clinical development experience, will greatly enhance our development efforts for this program and allow us to move forward more rapidly. In addition, by utilizing Roche’s brain shuttle technology with our antisense drug discovery capabilities, we have the potential to significantly improve the therapeutic potential for this program,” said B. Lynne Parshall, Chief Operating Officer of Isis. “By partnering our more complex and nuanced research and development programs earlier in development, like our Huntington’s disease CNS program, we add value and resources with partners that bring unique benefits.”

“We are excited to be working with Roche,” said Frank Bennett, Senior Vice President of Research at Isis. “We believe our mature antisense drug discovery platform is a perfect fit for Roche’s neuroscience franchise, and we anticipate a fruitful collaboration to advance our pre-clinical compounds.”

CHDI Foundation, a non-profit foundation exclusively dedicated to the development of therapies that slow the progression of HD, provided financial and scientific support to Isis’ HD drug discovery program through a development collaboration with Isis. CHDI’s support has enabled Isis to make significant progress in discovering a drug to treat HD. Together Isis and CHDI demonstrated that antisense compounds can be used to inhibit the production of HTT protein in both brain and peripheral tissues, and that the inhibition of normal HTT protein was well tolerated. Over time, CHDI will be reimbursed for its support of Isis’ program out of the milestone payments received by Isis. CHDI will receive $1.5 million associated with the signing of the Roche agreement. CHDI will continue to provide advice to Isis and Roche on the development of antisense drugs to treat patients with HD.

Isis also recognizes the tremendous benefit provided to its HD program by its academic collaborators, Drs. Don Cleveland at the Ludwig Institute, University of California San Diego and David Corey at University of Texas Southwestern. These collaborators have been instrumental in Isis’ early preclinical work demonstrating that antisense drugs can inhibit the HTT protein and produce activity in animal models of disease.

Source: Isis Pharmaceuticals

CardioDx Announces Medicare Coverage for Corus CAD Gene Expression Test for the Diagnosis of Obstructive Coronary Artery Disease

CardioDx, Inc., a pioneer in the field of cardiovascular genomic diagnostics, recently announced data demonstrating that Corus® CAD, the only clinically validated gene expression test for the assessment of obstructive coronary artery disease (CAD), has higher diagnostic accuracy than commonly used risk assessment modalities including symptom evaluation and myocardial perfusion imaging (MPI) in women. The sex-specific analysis of the PREDICT (Personalized Risk Evaluation and Diagnosis in the Coronary Tree) Trial was presented during a poster session at the Women’s Health 2013: 21st Annual Congress, which took place in Washington D.C. from March 22 nd – 24th.

There is a growing body of clinical evidence confirming that standard diagnostic approaches used to evaluate patients for obstructive CAD lead to many unnecessary noninvasive and invasive procedures such as MPI, stress echocardiogram, computed tomography angiography and coronary angiography, especially in women[1]. According to the results of the PREDICT Trial, MPI was not a significant predictor of obstructive CAD in women. This may be due to the presence of breast and fatty tissue in women, which leads to a higher rate of false-positive diagnoses[2] and, consequently, a higher rate of unnecessary referrals for additional invasive testing. The study also found that chest pain and other clinical factors are not reliable predictors of obstructive CAD in women. The traditional chest pain symptom classification as defined by Diamond and Forrester is helpful in diagnosing men, but does not correspond to presence of obstructive CAD in women. Furthermore, women with obstructive CAD tend to present with atypical, nonspecific symptoms such as shortness of breath, fatigue, and abdominal pain. Only the Corus CAD score and dyslipidemia were associated with the findings of obstructive CAD in women.

“Since the symptoms of coronary disease in women are not as well defined as in men, clinicians cannot use the same assessment criteria in women as they do in men,” said Alexandra Lansky, MD, Associate Professor of Medicine and Director of the Cardiovascular Research Center, Yale University School of Medicine, the senior author of the study and one of the PREDICT co-investigators. “Women have more angina and less obstructive coronary artery disease compared to age-matched men and are significantly over-referred to invasive coronary angiography, as current noninvasive diagnostic approaches have limitations in women. Women need tests that are both specific to their biology and can reliably assess the origin of their symptoms. Corus CAD is the only sex-specific test for evaluating obstructive CAD and represents a paradigm shift in how clinicians may diagnose heart disease in women, who account for half of the U.S. population.”

The PREDICT cohorts analyzed included 1,160 stable non-diabetic men and women referred for cardiac catheterization with typical and atypical symptoms suggestive of obstructive CAD or who were asymptomatic with a high risk of CAD: a substudy of 492 women was included in this sex-specific analysis. Of the women referred to invasive coronary angiography with abnormal MPI results (N=295), only 22 percent had obstructive CAD upon invasive coronary angiography. The study showed that Corus CAD results were more accurate than MPI and were significantly associated with the extent and severity of obstructive CAD. Corus CAD was a significant classifier of obstructive CAD in the overall population (p<0.001) and in the male (p=0.001) and female (p<0.001) subgroups separately, whereas MPI was not found to be an independent indicator of obstructive CAD. Each 10-point increase in the Corus CAD score was associated with a twofold increase in the likelihood of obstructive CAD in men, and a 3.4-fold increase in the likelihood of obstructive CAD in women. The results demonstrate the improved ability of Corus CAD to safely exclude obstructive CAD as a diagnosis, particularly in women.

Separately, a poster confirming the clinical utility of Corus CAD in the primary care setting to accurately exclude the diagnosis of obstructive CAD in stable, symptomatic female patients was also presented at the Women’s Health Congress. The poster titled, “The Use of a Personalized Gene Expression Test to Improve Decision Making in the Evaluation of Women with Symptoms of Suspected Obstructive Coronary Artery Disease” represents a substudy that included 141 women of a 317 total patient population in this sex-specific analysis led by Michael Conlin, MD, Johns Creek Primary Care. Results showed that Corus CAD scores could reliably separate female patients into elevated risk (score ≥15) and low risk (score ≤15) groups, allowing primary care physicians to more accurately triage patients. Use of Corus CAD led to a reduction in referrals to cardiologists of 77 percent in the low-scoring female patient group (p<0.001).

“With test overutilization contributing to the approximately $5 billion in annual cardiac-related diagnostic costs in this population, primary care providers are concerned with accountable care now more than ever,” said Dr. Conlin. “As the symptoms in women are harder to diagnose, they are often referred to additional and more invasive testing that ultimately produces low yields of obstructive CAD. Therefore, we welcome sex-specific tools like Corus CAD to help us more effectively identify the right patients who need further noninvasive and invasive cardiac workup.”

Among the 141 women studied, 73 percent had low Corus CAD scores. PCPs referred 12 percent of patients with low scores and 48 percent with non-low scores to cardiology. Of the patients with low scores who underwent additional testing, none were found to have clinically significant obstructive CAD. The average follow-up duration was 163 days, and no patients experienced a major adverse event during this time. 

Source: CardioDx

Miraculins to License Additional Preeclampsia Technology from Mount Sinai Hospital

Miraculins Inc. (TSX-V:MOM), a medical diagnostic company focused on acquiring, developing and commercializing diagnostic tests and risk assessment technologies for unmet clinical needs, announces today its plans to add to its suite of maternal health biomarkers under license from Mount Sinai Hospital’s Samuel Lunenfeld Research Institute by signing a term sheet to license methods and reagents for detecting hydroxylated Hypoxia Inducible Factor 1 alpha (“HIF-1aOH”), a promising biomarker with potential in differentiating high and low risk pregnancies, including risk of preeclampsia. The technology is part of the pioneering research on preeclampsia and placental development being conducted by Dr. Isabella Caniggia, Senior Investigator at the Samuel Lunenfeld Research Institute, in collaboration with Dr. Martin Post, a Senior Scientist at The Hospital for Sick Children. Dr.Caniggia is also a member of Miraculins’ Scientific Advisory Board and is cross-appointed at the University of Toronto as a Professor in Obstetrics and Gynecology as well as Physiology.

In addition to its promise in maternal health and preeclampsia, HIF-1aOH also presents an opportunity as a cancer biomarker and of further note, the license will include unique monoclonal antibodies highly sensitive to HIF-1aOH and the exclusive rights to manufacture reagents that measure the biomarker using materials developed by Dr. Caniggia. Miraculins is currently advancing a development plan for a kit to detect and measure HIF-1aOHin bodily fluid, which if successful could lead to a near term commercial research use product and allow for more widespread research into the utility of this novel biomarker. The ultimate goal for the biomarker development program would be worldwide sales of the biomarker technology, either alone or in combination with other markers, in a diagnostic kit for the early detection of preeclampsia or as a pregnancy risk assessment tool.

“Since HIF-1a is central to proper placental development, early detection of abnormal HIF-1a regulatory mechanisms could one day provide tools to physicians and caregivers to differentiate high and low risk pregnancies. Although HIF-1a itself is a very promising biomarker, the hydroxylated form may prove to be important to diagnosing the severity of preeclampsia and to better manage this disease throughout pregnancy,” stated Dr. Isabella Caniggia, the discoverer of the markers that comprise Miraculins’ preeclampsia biomarker suite and inventor of the HIF-1aOH technology. “I am very eager to expand our continued work with the Miraculins team to achieve the goal of better outcomes for mothers and babies.”

“We are very pleased to expand our maternal health program and partnership with Dr. Caniggia and Mount Sinai Hospital’s Samuel Lunenfeld Research Institute,” stated Christopher J. Moreau, President and Chief Executive Officer of Miraculins Inc. “This program has been very successful to date, and recently produced a license agreement for the biomarker Endoglin with a major global diagnostic company. We look forward to continuing research into this promising biological pathway with the goal of developing additional preeclampsia diagnostic tools for this devastating disease of growing incidence worldwide.”

Source: Miraculins