Study validates TGen developed test for healthcare-acquired infections

Molecular-based KlebSeq assay could save lives and lower healthcare costs

FLAGSTAFF, Ariz. — Sept. 2, 2016 — A new study by the Translational Genomics Research Institute (TGen) details the design and validation of a low-cost, rapid and highly accurate screening tool — known as KlebSeq  — for potentially deadly healthcare-acquired infections (HAIs), such as Klebsiella pneumoniae. HAIs affect hundreds of thousands of patients annually and add nearly $10 billion in associated healthcare costs.

The findings, to be published in the October issue of the Journal of Clinical Microbiology, detail the workings of the KlebSeq test at detecting HAIs earlier, in particular Klebsiella, which has multiple strains, such as ST258, which are increasingly resistant to treatment by antibiotics.

Unlike traditional assays that require growing a live culture in a laboratory setting, which adds days to the testing process and layers on cost, KlebSeq employs a technique called amplicon sequencing that identifies the presence of Klebsiella and stratifies its characteristics, such as strain type and whether it may be antibiotic resistant.

“KlebSeq is able to accurately and consistently identify and characterize Klebsiella from many different types of specimen samples, including blood, urine, nasal swabs, and respiratory fluids,” said Dr. Jolene Bowers, a Post-Doctoral fellow in TGen’s Pathogen Genomics Division, TGen North, and the paper’s first author.

In 2015, Bowers co-led a study published in PLOS One, in collaboration with the U.S. Centers for Disease Control and Prevention, which documented the rapid global spread of ST258.

According to the CDC, nearly 2 million Americans annually contract bacterial infections that are resistant to at least one antibiotic, and 23,000 die each year from such infections, nearly twice as many who die of AIDS.

“Improved testing technology holds great potential for the rapid detection of HAIs and more quickly identifying antibiotic-resistant infections, such as K. pneumoniae, which have become an urgent public health crisis,” said Bowers. “KlebSeq is a perfect example of the power of genomic-based analytical tools that deliver results faster, more accurately and at a lower cost.”

According to Dr. David Engelthaler, Director of Programs and Operations for TGen North, and one of the authors of the study, transmission of multidrug-resistant strains of K. pneumoniae is rapid and without initial symptoms, leading to outbreaks in the healthcare system and the community that often go undetected.

“Early detection of K. pneumoniae in healthcare patients, especially those with multidrug-resistant strains, is critical to infection control,” said Dr. Engelthaler, who also is a former epidemiologist for the state of Arizona. “Perhaps most concerning is that Kleb acts like a shuttle for critical resistance genes, often transmitting them to other HAI species. It is important for us to detect both the bacteria and these critical genes.”

KlebSeq can be used for routine screening and surveillance, enabling healthcare staff to make more informed patient decisions, and curb outbreak situations by rapidly identifying transmissions prior patients showing signs of infection. Classifying the type of infection in each patient would help enable an institution to decide when and which intervention procedures to enact.

Study results suggest that KlebSeq would be especially helpful for high-risk patients — those in intensive-care units, centers specializing in bone marrow transplantation or chronically immunosuppressed patients, long-term care facilities, and travelers returning from endemic regions.

“The sensitivity of KlebSeq is superior to culture-based methods,” said Dr. Paul Keim, Director of TGen North and the senior author of the study.

“KlebSeq is an important step toward a comprehensive, yet accessible, tool for all pathogen identification and characterization,” said Dr. Keim, who also is the Cowden Endowed Chair of Microbiology at Northern Arizona University, and Director of NAU’s Center for Microbial Genetics and Genomics (MGGen).

The results also suggest that KlebSeq could be easily modified to detect other healthcare-acquired infectious agents, and identify those with antimicrobial resistance. It could also be used for outbreak detection, transmission mapping and tracing the source of infections by being able to screen hundreds of patient samples simultaneously, at a cost of tens of dollars per patient.

KlebSeq: A Diagnostic Tool for Surveillance, Detection, and Monitoring of Klebsiella pneumoniae, will be published in the October 2016 issue of the Journal of Clinical Microbiology.

U.S. issues patent for Valley Fever detection technology developed by TGen and NAU

Test for dust-borne fungal infection created by TGen and NAU is licensed to DxNA 

PHOENIX, Ariz. — Aug. 2, 2016 — Valley Fever, a potentially deadly dust-borne fungal disease, should be easier to diagnose and treat thanks to a testing technology developed by the Translational Genomics Research Institute (TGen) and Northern Arizona University (NAU), and now protected by a patent issued today by the U.S. Patent and Trademark Office.

TGen and NAU have exclusively licensed this technology to DxNA LLC, a company based in St. George, Utah, which plans to make this Valley Fever Test commercially available to hospitals and clinics upon completion of FDA clinical trials and a subsequent FDA 510(k) submission for review and clearance later this year.

Valley Fever is endemic to Phoenix and Tucson, but also is spreading throughout the arid regions of North and South America. It is an infection caused by the microscopic fungus Coccidioides, a pathogen that lives in desert soils and typically enters the body through the lungs. An estimated 150,000 Americans are infected annually by Valley Fever, and as many as 500 die each year.

“Currently, there is no definitive test for Valley Fever. Our new rapid, 1-hour, genetic-based test will provide physicians and patients with a precise diagnosis, enabling prompt treatment and preventing this disease from becoming more serious,” said Dr. Paul Keim, Director of TGen’s Pathogen Genomics Division, or TGen North, based in Flagstaff.

“For the past decade, TGen has worked to develop better tools and technology to address Valley Fever, and we think it is critical to be able to apply our cutting-edge science to problems in our own backyard,” said Dr. Keim, who also is the Cowden Endowed Chair of Microbiology at NAU, and Director of NAU’s Center for Microbial Genetics and Genomics (MGGen).

Valley Fever most commonly causes a progressive lung infection, but can also spread to other parts of the body, including the skin, bone, brain and the rest of the nervous system.

Nearly 60 percent of those infected by Valley Fever — including other vertebrates, and especially dogs — develop no significant symptoms. However, some patients develop highly debilitating symptoms, such as cough, fever and fatigue. These symptoms are similar to other respiratory diseases caused by bacteria or virus, and often lead to delayed diagnoses and inappropriate treatment. Very severe Valley Fever can require lifelong treatment with antifungal drugs, and even result in death.

This new genetic-based test can precisely identify both strains of Valley Fever: Coccidioides posadasii, found in Arizona, New Mexico, Texas and much of Latin America, and Coccidioides immitus, which is found in California, Washington and Baja Mexico.

Most infections occur in central and southern Arizona. Each year on average, there are an estimated 150,000 cases in Arizona, resulting in more than 1,700 hospitalizations at a cost of more than $86 million.

“These high costs are driven to a significant degree by the high level of misdiagnosis, resulting in an average time to diagnosis of 5 months from when a patient first seeks care,” said David Taus, CEO of DxNA LLC. “Our test provides definitive results in 60 minutes, dramatically improving the diagnosis of the disease over current methodologies, both in terms of time and accuracy.”

The intellectual property used in DxNA’s Valley Fever Test is exclusive to DxNA LLC, and covers both human and veterinary applications, Taus said.

‘Cycle for the Cure’ Raises a Record $248,725 for Cancer Research at TGen

Philanthropists Sherry and Richard Holson are instrumental in securing $100,000 in donations from Guarantee Trust Life

PHOENIX, Ariz. —  This year’s Cycle for the Cure already was on track to be one of the most successful in its six years of raising cancer research funds for the non-profit Translational Genomics Research Institute (TGen).

But thanks to additional donations generated by Guarantee Trust Life of Glenview, Ill., the 6th annual Cycle for the Cure garnered a record $248,725 for TGen.

The May 1 event, which featured hundreds of dedicated donors spinning on stationary cycles for up to 2 hours at several health clubs in Phoenix and Scottsdale, produced $173,725.

But Vicki Vaughn, Co-Chair of Cycle for the Cure, wasn’t finished.

After introducing her friends — Richard S. Holson III, Chairman, CEO and President of Guarantee Trust Life, and his wife, Sherry — to TGen, the Holson’s company invited TGen cancer researcher Dr. Will Hendricks and TGen Foundation Vice President Erin Massey to present at Guarantee Trust Life’s recent company conference in Arizona. The company was impressed and donated $25,000, part of the initial tally for Cycle for the Cure.

Then, after company officials toured TGen laboratories, they challenged their partners and representatives to donate to Cycle for the Cure. They raised a combined $37,500, which Guarantee Trust Life matched, dollar-for-dollar, adding another $75,000 to the $25,000 the company already donated, bringing the total generated by Guarantee Trust Life to $100,000.

“TGen should be very grateful to my wife, Sherry, and Vicki Vaughn as they were responsible for introducing my company to this amazing organization. We were impressed with, and inspired by, the remarkable people at TGen and the world-class, life-changing research being conducted,” said Richard Holson. “And the response by our agents with their contributions was great.”

Using genomic sequencing, TGen helps doctors match the appropriate therapy to each patient’s DNA profile, producing the greatest patient benefit. This year, Cycle for the Cure raised research funds for work on a revolutionary diagnostic method called “liquid biopsies” — biomarkers in circulating blood — as a means of providing patients and their doctors with early detection of disease.

“We believe everyone should know first-hand about the groundbreaking research going on at TGen, and we encourage everyone to join us in supporting the vital work TGen does,” said Vicki Vaughn, who co-chaired Cycle for the Cure with Robyn DeBell.

Village Health Clubs and Studio 360 provided the venues for this year’s Cycle for the Cure. In addition, yoga and kinesis classes were included in the fundraising events by Village Health Clubs at its DC Ranch and Camelback locations.

“We are incredibly proud to have merited the dedicated support of volunteer co-chairs Vicki Vaughn and Robyn DeBell,” said TGen Foundation President Michael Bassoff. “Their extraordinary leadership, and the generosity of business leaders like Rick Holman and the Guarantee Trust Life company, provides an incredible boost to TGen’s cancer research initiatives.”

Donations continue to be accepted at www.tgenfoundation.org/cycle. And save the date for next year’s 7th annual Cycle for the Cure: April 30, 2017.

World-renowned Sarod Maestro Plays Benefit Concert for TGen

Amjad Ali Khan’s fundraiser Sept. 3 at the Tempe Center for the Arts will help hundreds of Arizona children with rare medical disorders

TEMPE, Ariz. Sarod virtuoso Amjad Ali Khan — who has graced the most celebrated stages of the globe and shared musical billings with artists as varied as Queen Latifah and Steven Tyler — will perform a benefit concert for the Translational Genomics Research Institute (TGen).

Khan and other Indian classical musicians will perform at 7 p.m. Sept. 3 at the Tempe Center for the Arts, 700 W. Rio Salado Parkway, to benefit TGen’s Center for Rare Childhood Disorders (C4RCD).

“Sarod for C4RCD” will feature: a solo by Khan on his lute-like stringed instrument; a duet by his son, seventh-generation sarod master Ayaan Ali Bangash, and Grammy-nominated violinist Elmira Darvarova; and a third set with all three musicians plus tabla (Indian two-piece drum) extraordinaire Anubrata Chatterjee.

“It is indeed a matter of great joy and honor for me to present my music for the music lovers of Phoenix,” said Khan. “I am so humbled to be associated with the Center for Rare Childhood Disorders at TGen.”

He was invited to perform in Phoenix at the benefit concert by Indian-born Dr. Vinodh Narayanan, Medical Director of TGen’s C4RCD, which since 2012 has harnessed the latest in genomic sequencing technology to pinpoint the genetic causes of rare medical disorders.

“This music from my beloved India reaches in and touches the soul; it is something anyone can appreciate and enjoy,” said Dr. Narayanan. “The fact that it will be performed by the world’s top artists makes this fundraising event something not to be missed. It is indeed a chance of a lifetime for all of us in Arizona. It’s an event that will benefit hundreds of children struggling to survive rare and difficult-to-treat medical conditions.”

Khan has performed at: the WOMAD (World of Music, Arts and Dance) Festival in Adelaide, Australia, and New Plymouth, New Zealand; Edinburgh International (Music) Festival in Scotland; World Beat Festival in Brisbane, Australia, and Taranaki, New Zealand; The BBC Proms in London; Shiraz Arts Festival in Iran; Hong Kong Arts Festival; Adelaide Music Festival; 1200 Years celebration of Frankfurt; WOMAD Festival in Rivermead, England; and the Schonbrunn Palace in Vienna.

He has been a regular performer at Carnegie Hall in New York, Royal Albert Hall in London, the Kennedy Center in Washington, D.C., Victoria Hall in Geneva, Chicago Symphony Center, Mozart Hall in Frankfurt, and the Sydney Opera House in Australia.

In 2014, Amjad Ali Khan and his sons, Amaan Ali Bangash and Ayaan Ali Bangash, performed at the prestigious Nobel Peace Prize ceremony in Oslo, Norway, as well as the Nobel Peace Prize Concert along with a lineup that included Queen Latifah, Steven Tyler, Nuno Bettencourt and Laura Mvula.

In January, Khan performed for His Holiness The Dalai Lama’s 80th birthday celebration in New Delhi.

Tickets for the Sept. 3 concert are $200, $150 and $100 with all proceeds benefiting TGen’s Center for Rare Childhood Disorders. Tickets may be purchased at the Tempe Center for the Arts box office, by telephone at 480-350-2TCA (2822) or online at http://tca.ticketforce.com/SARODforC4RCD.

Food and beverages will be available for purchase.

For more information about these artists, please visit: www.sarod.com.

MRSA Detection Technology Developed by TGen-NAU is Granted First Patent

Test for ‘superbug’ bacterial infections created by DxNA under license from TGen-NAU

PHOENIX, Ariz. — Antibiotic-resistant infections should be easier to detect, and hospitals could become safer, thanks to a technology developed by the Translational Genomics Research Institute (TGen) and Northern Arizona University (NAU), and protected under a patent issued by Australia.

Soon, similar patent approvals are expected by the U.S., Canada, European Union, Japan, Brazil and other nations for this “superbug” test developed by TGen and NAU, and licensed to DxNA LLC, a company based in St. George, Utah.

“This rapid, 1-hour test will precisely identify a family of antibiotic-resistant Staphinfections we broadly refer to as MRSA,” said Dr. Paul Keim, Director of TGen’s Pathogen Genomics Division, or TGen North, based in Flagstaff.

“We hope this technology will be adopted worldwide by hospitals and clinics, and will help identify and isolate these dangerous and difficult-to-eliminate infections that have come to plague our medical institutions,” said Dr. Keim, who also is the Cowden Endowed Chair of Microbiology at NAU, and Director of NAU’s Center for Microbial Genetics and Genomics (MGGen). “The result should be more rapid diagnosis, improved treatment of patients, and reduced medical costs.”

MRSA — Methicillin-resistant Staphylococcus aureus — is an antibiotic-resistant form of the Staph bacteria that annually kills more Americans than HIV.

While MRSA technically refers to one particular strain of Staph, the genomics-based test developed by TGen, NAU and DxNA can precisely detect multiple types of drug-resistant Staph bacterial infections, including drug resistant Coagulase Negative Staphylococcus (CSN), a much more common infection than MRSA.

Staph infections are the most common hospital-acquired or associated infections. While most of the focus over the past few years has been on MRSA, in terms of incidence and total cost, strains of Staph other than MRSA are a much more common problem.

Due to the increasing use of implantable biomaterials and medical devices, infections are increasingly caused by CNS. This is a type of Staph that is often resistant to multiple antibiotics and has a particular affinity for these devices.

“Rapid identification and differentiation of these resistant bacteria is key to optimizing treatment decisions that significantly impact patient outcomes and cost of care,” said David Taus, CEO of DxNA LLC. “Given that resistant CNS is a frequent pathogen in surgical site infections, orthopedic and cardiac device infections, and blood stream infections — among others — it is critical that we be able to rapidly identify and determine antibiotic resistance to provide for appropriate pre-surgical antibiotic prophylaxis to prevent infections and early and effective treatment when these infections do occur.”

Current molecular tests for MRSA all ignore CNS, rendering their results significantly less useful in treating patients given that drug resistant CNS infections are many times more common than MRSA.

DxNA’s Staphylococcus Test identifies and differentiates resistant and non-resistant strains of Staph and CNS. The test uses three separate proprietary biomarker targets and a proprietary methodology to determine which types of Staph are present, and which carry the gene that causes antibiotic-resistance in these bacteria.

“The test also is effective in identifying infected specimens where there are multiple types of Staph. The test will rapidly provide broader clinically-actionable results, improving antibiotic prophylaxis, early targeted intervention resulting in more effective treatment at lower costs,” Taus said.

Macy’s ‘Shop For A Cause’ Aug. 26-28 Supports Cancer Research at TGen

All proceeds from ‘Shop For A Cause’ shopping passes benefit TGen pancreatic cancer patients; shoppers receive substantial discounts

PHOENIX, Ariz. — Here is one more reason to do your back-to-school shopping at Macy’s:  “Shop For A Cause” shopping passes will provide needed research dollars for the non-profit Translational Genomics Research Institute (TGen), benefitting pancreatic cancer patients.

This 11th annual “Shop For A Cause” at Macy’s is no longer a one-day event. This year, “Shop For A Cause” passes will be honored at Macy’s throughout the weekend of Aug. 26-28.

Now through Aug. 25, “Shop For A Cause” passes may be purchased for only $5 by visiting helptgen.org/macys or by calling 602-343-8411. Shopping passes will provide up to 25 percent off most merchandise, and provide an opportunity to win a $500 Macy’s gift card.

“More than ever, Macy’s is finding ways to help charity and non-profit organizations, such as TGen, to help those in need,” said Dr. Haiyong Han, Associate Professor of TGen’s Clinical Translational Research Division. “ ‘Shop For A Cause’ will benefit pancreatic cancer patients who desperately need our help today.”

This year, pancreatic cancer will surpass breast cancer as America’s third-leading cause of cancer-related death, with more than 53,000 newly diagnosed patients, and nearly 42,000 deaths. More than 75 percent of pancreatic cancer patients die within the first year of diagnosis, and fewer than 10 percent survive for more than 5 years.

The pancreas is a banana-shaped organ behind the stomach that produces digestive enzymes, as well as hormones such as insulin to help regulate blood sugar. Because there is no screening test, and usually no symptoms in its early stages, pancreatic cancer usually is not diagnosed until its advanced stages, when surgery often is no longer an option and treatment is more difficult.

TGen’s focus is on early detection, and groundbreaking clinical trials, which recently have shown tumor reductions of 30 percent or more in nearly 8 out of 10 advanced pancreatic cancer patients. TGen’s progress could not come at a more critical time. During the past 5 years, as the U.S. population continues to grow, the number of deaths attributed to other leading cause of cancer death — lung, colon and breast cancers — have remained steady, while the number of deaths due to pancreatic cancer have increased by nearly 11 percent.

All dollars — 100 percent — raised in the Phoenix area by “Shop For A Cause” will go toward TGen’s annual stepNout run/walk/dash program, which funds pancreatic cancer research. This year’s stepNout event is scheduled for Nov. 6 at the Scottsdale Sports Complex.

Macy’s “Shop For A Cause” is a unique shopping event dedicated to supporting local nonprofit organizations’ fundraising efforts. Since 2006, the program has helped raise tens of millions of dollars for charities throughout the nation, and more than 5,000 charities signed up to participate last year.

“At Macy’s, we believe in supporting the communities where our customers and associates live and work. That is why we are so proud of ‘Shop For A Cause,’ ” said Holly Thomas, Macy’s group vice president of cause marketing. “With this year’s extension to a weekend-long event, we’re offering even more opportunity to support local and national causes, and thanking our customers with special savings at Macy’s.”

To find a Macy’s near you, go to mcys.co/1D3ZrXl. For more information about Macy’s “Shop For A Cause,” visit macys.com/shopforacause.

TGen Receives Approval for Patient Enrollment in Brain Cancer Clinical Trial

Catherine Ivy and Dr. David Craig

 

Glioblastoma (GBM) Pilot Trial funded by Ivy Foundation

In 2012, The Ben & Catherine Ivy Foundation awarded $10 million in grants for two groundbreaking brain cancer research projects at the Translational Genomics Research Institute (TGen). One of those projects has officially received the final regulatory approval from University of California, San Francisco, which means patient enrollment for the trial can begin.

 

In the $5-million-project, “Genomics Enabled Medicine in Glioblastoma Trial,” TGen and its clinical partners will lead first-in-patient clinical trial studies that will test promising new drugs that might extend the survival of GBM patients. This multi-part study will take place in clinics across the country and TGen laboratories.

 

“GBM is one of the top three fastest-killing cancers out there and it affects people of all ages,” said Catherine (Bracken) Ivy, founder and president of The Ben & Catherine Ivy Foundation. “It is critical that we fund research that will help patients live longer so we can study and treat brain cancer.”

 

The project begins with a pilot study of 15 patients, using whole genome sequencing to study their tumor samples to help physicians determine what drugs might be most beneficial.

 

To support molecularly informed clinical decisions, TGen labs also will examine genomic data from at least 536 past cases of glioblastoma, as well as tumor samples from new cases, developing tools that will produce more insight into how glioblastoma tumors grow and survive. TGen also will conduct a series of pioneering lab tests to measure cell-by-cell responses to various drugs.

 

“GBM is a disease that needs answers now, and we strongly believe those answers will be found in the genome,” said Dr. David Craig, TGen’s Deputy Director of Bioinformatics, Director of TGen’s Neurogenomics Division, and one of the projects principal investigators. “Identifying the genes that contribute to the survival of glioblastoma will provide valuable information on how to treat it, and may also lead to an improved understanding of what drives other cancers as well.”

 

To get new treatments to patients as quickly as possible, this five-year study will include a feasibility study involving up to 30 patients, followed by Phase II clinical trials with as many as 70 patients. TGen is teaming with the Ivy Early Phase Clinical Trials Consortium that includes: University of California, San Francisco; University of California, Los Angeles; the MD Anderson Cancer Center; Memorial Sloan Kettering Cancer Center; University of Utah; and the Dana-Farber/Harvard Cancer Center.

 

The results of these clinical trials should not only help the patients who join them, but also provide the data needed for FDA approval and availability of new drugs that could benefit tens of thousands of brain cancer patients in the future.

 

“Working with physicians, the project will aim to understand treatment in the context of the tumor’s molecular profile. We will have the opportunity to determine when combinations of drugs might be more effective than using a single drug, quickly identify which therapies don’t work, and accelerate discovery of ones that might prove promising for future development,” said Dr. John Carpten, TGen’s Deputy Director of Basic Science, Director of TGen’s Integrated Cancer Genomics Division, and another of the project’s principal investigators.

 

In addition to helping patients as quickly as possible, the project should significantly expand Arizona’s network of brain cancer experts.

 

About The Ben & Catherine Ivy Foundation

The Ben & Catherine Ivy Foundation, based in Scottsdale, Ariz., was formed in 2005, when Ben Ivy lost his battle with glioblastoma multiforme (GBM).  Since then, the Foundation has contributed more than $50 million to research in gliomas within the United States and Canada, with the goal of better diagnostics and treatments that offer long-term survival and a high quality of life for patients with brain tumors.  The Ben & Catherine Ivy Foundation is the largest privately funded foundation of its kind in the United States.  For more information, visit http://www.ivyfoundation.org. We have regular updates via social media – please find us on:

Blog:  Ivy Foundation http://www.IvyFoundation.wordpress.com

Facebook:  Ivy Foundation  http://www.facebook.com/IvyFoundation

Twitter:  @IvyFoundation https://twitter.com/IvyFoundation

Google+:   Ivy Foundation https://plus.google.com/105982076267406579679/posts

LinkedIn:  Ivy Foundation http://linkedin.com/company/the-ben-and-catherine-ivy-foundation

YouTube:  IvyFoundationGBM http://www.youtube.com/user/IvyFoundationGBM

 

About TGen

The Translational Genomics Research Institute (TGen) is a Phoenix-based non-profit organization dedicated to conducting groundbreaking research with life changing results. Research at TGen is focused on helping patients with diseases such as cancer, neurological disorders and diabetes. TGen is on the cutting edge of translational research where investigators are able to unravel the genetic components of common and complex diseases. Working with collaborators in the scientific and medical communities, TGen believes it can make a substantial contribution to the efficiency and effectiveness of the translational process. For more information, visit: www.tgen.org.

Riddell and TGen Team Up with Arizona State University’s Football Program to Further Genetic Research into Athlete Concussion Detection and Treatment

2014 Football Season Marks the Second Year of the Research Partnership

Study Using Sun Devils’ Head Impact Data and Genetic Information Could Help Improve Player Protection, Inform New Helmet Designs and Refine Smart Helmet Technology

 

PHOENIX, Ariz., ROSEMONT, Ill. and TEMPE, Ariz. — August 26, 2014 — Riddell, the leader in football helmet technology and innovation, and the Translational Genomics Research Institute (TGen), a leader in cutting-edge genomic research, today announced that the Pac-12’s Arizona State University and its Sun Devil football program will again participate in a genetic research study designed to advance athlete concussion detection and treatment.

Now in its second year, the joint research project will combine molecular information and head impact data from Sun Devil football student-athletes to identify whether the effects of sub-concussive hits are identifiable. The researchers will monitor the players’ changing molecular information throughout a season of typical head impact exposure associated with football practice and games. Representatives from the Sun Devil medical team and TGen will collect the molecular samples from the participating athletes, all of whom volunteered to partake in the study.

“This partnership represents another dynamic and innovative step toward ensuring that the health and well-being of our student-athletes remains our most important goal,” Vice President for Arizona State University Athletics Ray Anderson said. “Sun Devil Athletics continues to serve as a pioneering force in this important issue and is proud to participate in this world-class research study for the second consecutive year with two outstanding industry trendsetters in Riddell and TGen.”

Arizona State’s preferred helmet and protective equipment provider, Riddell, has again deployed its Sideline Response System (SRS) to obtain real-time head impact data from Arizona State football student-athletes. Riddell SRS provides researchers with a wide range of valuable information on the frequency and severity of head impacts a player receives during games and practices. Data gathered from the system will be combined with genetic information from players that experience concussion, with the objective of helping physicians diagnose concussion and better identify when a player might be expected to recover and return to the field.

“Player protection has become an essential part of football, and this cutting-edge partnership sets ASU apart from not only the rest of the conference, but every collegiate football program in the nation,” ASU Head Coach Todd Graham said. “We are not only looking out for our student-athletes while they are enrolled at ASU, but for the rest of their lives. You become a part of the brotherhood once you put on the maroon and gold, and that doesn’t end at graduation.”

Riddell will also utilize the player head impact data collected from the ASU and TGen research partnership to inform the development of new football helmets and further refine updates to smart helmet technologies like Riddell SRS and its recently launched Riddell InSite Impact Response System.

“We’re impressed by the enthusiasm exhibited by our partners, Arizona State University and TGen, as we enter the second season of our important research collaboration,” President of Riddell Dan Arment said. “They have matched our level of passion for football, and we are all committed to better protecting those that play the sport we love. We are left encouraged following the first year of our project and look forward to continuing on the path towards advancing concussion detection and treatment of athletes.”

The researchers at TGen are exploring whether the effects of sub-concussive hits are identifiable through blood-based molecular information. Their findings could prove pivotal to the game of football and other sports. Similar to last season, during this phase of the study the TGen faculty and staff are on the sidelines collecting samples and data. A baseline sample was collected from all participating players prior to their pre-season workouts. Since then, the researchers have followed the team through their daily workouts and will continue throughout the season.

Through the collection of samples over various points in time and the data generated by Riddell SRS, the goal is to identify the genomic changes in athletes exposed to routine head impacts during practice and games, athletes with diagnosed concussions that recover on both a routine time scale, and athletes with persistent symptoms following concussion that require additional treatment.

“As the mother of a young son who has played football, I’m keenly aware of the need to improve the current standards in place today for dealing with this issue,” said TGen Associate Professor Dr. Kendall Van Keuren-Jensen, whose technique for studying the collected samples drives this unique partnership. “As a researcher whose daily work looks for ways to determine the early warning signs of head injury, I get to see first hand how committed Arizona State University and Riddell are to student-athlete safety, and their determination to improve the game at all levels.”

Following the season long campaign, the researchers will gather post-season data and begin the analysis process with their colleagues at Barrow Neurological Institute and A.T. Still University. During this process, TGen will work closely with Barrow, 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. The Barrow data will provide the researchers with additional concussion data and allow for comparison between data sets.

About Riddell
Founded in 1929, Riddell is a premier designer and developer of protective sports equipment and a recognized leader in helmet technology and innovation. One BRG Sports most well-known brands, Riddell is the leading manufacturer of football helmets, shoulder pads and reconditioning services (cleaning, repairing, repainting and recertifying existing equipment). For more information, visit our website at http://www.riddell.com, like the Riddell Facebook page, or follow Riddell on Twitter @RiddellSports.

About Arizona State University
Arizona State University is a New American University—a major public educational institution, a premier research center and a leader in innovation. Our vision is described by our three core principles: excellence in scholarship, access to education and impact in our global community. As a New American University, ASU is intellectually vibrant, socially conscious and globally engaged.

About TGen
Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life changing results. TGen is focused on helping patients with neurological disorders, cancer, and diabetes, through cutting edge translational research (the process of rapidly moving research towards patient benefit).  TGen physicians and scientists work to unravel the genetic components of both common and rare complex diseases in adults and children. Working with collaborators in the scientific and medical communities literally world-wide, TGen makes a substantial contribution to help our patients through efficiency and effectiveness of the translational process. For more information, visit: www.tgen.org.

TGen News

New therapy for pancreatic cancer patients shows promising results

TGen-Scottsdale Healthcare lead international clinical trials in advance of FDA application for NAPOLI-1

SCOTTSDALE, Ariz. — June 6, 2014 — A clinical trial conducted by researchers at the Virginia G. Piper Cancer Center Clinical Trials, a partnership between Scottsdale Healthcare and the Translational Genomics Research Institute (TGen), showed that a new drug called MM-398, given in combination with 5-flourouracil (5FU) and leucovorin, produced a significant overall survival rate in patients with advanced, previously-treated pancreatic cancer.

The NAPOLI-1 (NAnoliPOsomaL Irinotecan) Phase 3 study — a final confirmation of a drug’s safety and effectiveness — was conducted among patients with metastatic pancreatic cancer who previously received gemcitibine, which has been the standard-of-care therapy for such patients.

The study, sponsored by Merrimack Pharmaceuticals, evaluated 417 patients enrolled at more than 100 sites in North America, South America, Europe, Asia and Australia, including patients at the Virginia G. Piper Cancer Center at Scottsdale Healthcare. Merrimack expects to submit a New Drug Application this year to the U.S. Food and Drug Administration (FDA) for the MM-398 combination regimen.

“This demonstration of a survival benefit from the MM-398 plus 5-FU and leucovorin combination is particularly important given that we have very few treatment options for patients in this tough clinical setting,” said Dr. Daniel D. Von Hoff, MD, FACP, global principal investigator of the NAPOLI-1 study, Chief Scientific Officer for Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials and Physician-In-Chief and Distinguished Professor at TGen. “The results of the NAPOLI-1 study are important because of the critical need to help patients with this devastating illness and move forward towards FDA approval.”

The combination of MM-398 with 5-fluorouracil (5-FU) and leucovorin achieved an overall survival of 6.1 months, a 1.9 month improvement over the 4.2 month survival demonstrated by the control arm of 5-FU and leucovorin alone.

Each year in the U.S., nearly 46,000 people are diagnosed with pancreatic cancer, and more than 39,000 patients die, making it the fourth leading cause of cancer death. Only about 1 in 4 patients survive more than one year after diagnosis, and only 6 percent survivor more than five years.

Symptoms of pancreatic cancer usually do not appear until the cancer is in its late stages, making it difficult to treat. Once the disease spreads to other parts of the body, most patients are not candidates for surgery and receive chemotherapy as their primary treatment.

This study will be presented at the European Society for Medical Oncology World Conference on Gastrointestinal Cancer being held June 25-28 in Barcelona, Spain.

Patients seeking information about research studies may contact the Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare at 480-323-1339 or toll free at 1-877-273-3713 or e-mail: clinicaltrials@shc.org.

About the Virginia G. Piper Cancer Center at Scottsdale Healthcare
The Virginia G. Piper Cancer Center at Scottsdale Healthcare in Scottsdale, Ariz. offers comprehensive cancer treatment and research through clinical trials, diagnosis, treatment, prevention and support services in collaboration with leading scientific researchers and community oncologists. The Virginia G. Piper Cancer Center at Scottsdale Healthcare, Scottsdale Healthcare Research Institute, Scottsdale Healthcare Osborn Medical Center, Scottsdale Healthcare Shea Medical Center and Scottsdale Healthcare Thompson Peak Hospital and related entities are affiliates of the non-profit Scottsdale Lincoln Health Network. For more information, visitwww.shc.org.

About TGen
Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life changing results. TGen is focused on helping patients with cancer, neurological disorders and diabetes, through cutting edge translational research (the process of rapidly moving research towards patient benefit).  TGen physicians and scientists work to unravel the genetic components of both common and rare complex diseases in adults and children. Working with collaborators in the scientific and medical communities literally worldwide, TGen makes a substantial contribution to help our patients through efficiency and effectiveness of the translational process. For more information, visit:www.tgen.org.