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.

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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.

Medical Heroes Appreciation 5K Run & Walk

LAUNCHES INAUGURAL 5K RUN & WALK EVENT TO RECOGNIZE ALL CLINICAL TRIAL VOLUNTEERS

Partnership with DIA to Honor People Who Give the Gift of Participation in Clinical Research

BOSTON, MA – March 1, 2014 — The Center for Information and Study on Clinical Research Participation (CISCRP), an independent non-profit, is excited to announce the launch of a new event — Medical Heroes Appreciation 5K Run & Walk in San Diego — to celebrate the volunteers who give the gift of participation in clinical research. The first annual Medical Heroes Appreciation 5K Run & Walk will coincide with the Drug Information Association (DIA) 2014 Annual Meeting. The event will take place on Monday, June 16, 2014 outside the San Diego Convention Center from 6:45-8:00am. Participants are encouraged to register early as space is limited. To register, visit ciscrp.org/med-hero-5k.

“Medical Heroes are the millions of people who help advance public health and medical knowledge by taking part in clinical trials each year,” said CISCRP’s founder, Ken Getz. “This special event recognizes their gift, raises public awareness and appreciation, and hopefully will become an annual tradition.”

Running and walking enthusiasts and all supporters of CISCRP’s mission are invited to participate or attend the event to show their support. Proceeds from the event will support education and outreach programs to patients and families interested in learning more about the clinical research process.

“We are honored the inaugural offering of the Medical Heroes Appreciation 5K will be held during the 50th Anniversary of DIA’s Annual Meeting.” said Lori Risboskin, DIA’s Associate Director Event Planning & Exhibits. “DIA members understand the importance of clinical research volunteers and appreciate their participation in clinical trials. We’re delighted to help CISCRP launch this special event.”

Registrants will have the opportunity to check-in early on Sunday June 15, 2014 from 8am – 9am, 12pm – 1pm, and 3pm – 6pm to receive event materials and giveaways. Regular check-in the day of the event begins at 6am; and the 5K Run & Walk will begin at 6:45am. For more information about the event, to volunteer, register or become a sponsor, visit ciscrp.org/med-hero-5k. Questions about event registration should go to Ellyn Getz (617) 725-2750, e-mail medhero5k@ciscrp.org, or call toll free 1-877-MED-HERO.

About CISCRP

CISCRP is a 501(c)(3) non-profit organization dedicated to engaging the public and patients as partners in the clinical research process. CISCRP provides free education and outreach to the general public and patient communities. Visit www.CISCRP.org for more information or to support CISCRP.

About the DIA 2014 50th Annual Meeting

The DIA Annual Meeting is the premier event for professionals involved in the discovery, development and lifecycle management of pharmaceuticals, biotechnology, medical devices and related medical products. No other industry event rivals the depth and breadth of experience that this meeting delivers through 20 interest-area tracks, 260+ program offerings and 18 pre-conference tutorials. The presentations are geared to attendees of all disciplines and experience levels. Visit our website at www.diahome.org and follow DIA at: LinkedIn, Twitter, YouTube, Facebook, Flickr, and Pinterest.

https://www.ciscrp.org/programs-events/events/annual-medical-heroes-appreciation-5k/

 

 

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.

 

 

Congratulations to TGen’s Dr. Bodour Salhia

TGen’s Dr. Bodour Salhia named to 2014 Class of 40 Under 40

Newspaper recognizes TGen cancer researcher among Phoenix’s brightest young leaders

PHOENIX, Ariz. — May 6, 2014 — Dr. Bodour Salhia, a cancer researcher at the Translational Genomics Research Institute (TGen), has been named one of the Phoenix Business Journal’s 2014 Class of 40 Under 40.

Dr. Salhia, an Assistant Professor in TGen’s Integrated Cancer Genomics Division, will be among the 40 up-and-coming Phoenix leaders — less than 40 years of age — at an awards reception June 19 at Phoenix Theater.

In his award notification letter to Dr. Salhia, PBJ Publisher Don Henninger said, “I speak for all the judges in saying that we feel honored to have seen a glimpse of your life and career. You are most certainly a valuable member of our community and a source of inspiration for all.”

All 40 Under 40 classmates will be featured in a special section of the June 20 edition of the PBJ.

“Bodour is a gem; brilliant and transparent. She is an incredible asset to TGen and to the state of Arizona. Watching her growth and career ascent has been one of the highlights of my entire career,” said Dr. John Carpten, TGen Deputy Director of Basic Science.

“She is an amazing scientist, but also frequently participates in patient advocacy and community education,” said Dr. Carpten, also Professor and Director of TGen’s Integrated Cancer Genomics Division. “We are so proud of Bodour. To me, this is not simply a recognition of her achievements, but also a reward for all that she does for others.”

Dr. Salhia, who specializes in researching breast cancer and multiple myeloma, is the fourth TGen staff member in three years to be selected to PBJ’s 40 Under 40. Dr. Matt Huentelman, an Associate Professor in TGen’s Neurogenomics Division, and Dr. Glen Weiss, a Clinical Associate Professor in TGen’s Cancer and Cell Biology Division, were named in 2013. Dr. Candice Nulsen, TGen’s former Director of Education and Community Outreach, was selected in 2012.

“I am so thankful and humbled to be selected among this year’s 40 Under 40 by the Phoenix Business Journal,” said Dr. Salhia, whose community work has included outreach to cancer patients of the Navajo Nation, and service as a board member of Susan G. Komen for the Cure, Central and Northern Arizona Affiliate. “This award is not just about me, but also reflects all the cutting-edge research that TGen conducts, using the human genome to devise better treatments for patients today.”

The 40 Under 40 program’s hundreds of alumni includes Phoenix Mayor Greg Stanton, a member of the TGen Board of Directors, and Arizona Diamondbacks President Derrick Hall, a member of TGen’s National Advisory Council for Pancreatic Cancer Research.

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.

 

 

Learn About Brain Cancer

Brain Cancer

A disease of the brain in which cancer cells (malignant) arise in the brain tissue. Cancer cells grow to form a mass of cancer tissue (tumor) that interferes with brain functions such as muscle control, sensation, memory, and other normal body functions.

Brain Tumor

An abnormal growth of tissue in the brain.  Unlike other tumors, brain tumors spread by local extension and rarely metastasize (spread) outside the brain.

Clinical Trials

Research studies done to determine whether new drugs, treatments, or vaccines are safe and effective.  They are conducted in three phases:

  • Phase I
    In this phase, small groups of people are treated with a certain dose of a new agent that has been extensively studied in the laboratory. During the trial, the dose is increased group by group to find the highest dose that does not cause harmful side effects. Usually there is no control treatment for comparison. This process determines a safe, appropriate dose for use in Phase II.
  • Phase II
    This phase provides continued safety testing of a new agent, along with an evaluation of how well it works against a specific type of cancer. The new agent is given to groups of people and is usually compared with a standard treatment.
  • Phase III
    This phase answers research questions across the disease continuum and includes large numbers of participants so that the differences in effectiveness of the new agent can be evaluated. If the results of this phase merit further use of the new agent, the pharmaceutical company will usually submit a New Drug Application to the FDA.

Diagnostics

The determination of the nature of a disease or ailment.  A clinical diagnosis is based on the medical history and physical examination of the patient.

Glial Cells

Cells that provide structure to the central nervous system and insulate and protect neurons (cells that transmit electrical impulses that allow seeing/hearing/smelling/tasting).

Glioma

The term used to refer to the most prevalent primary brain tumors.  Gliomas arise from glial tissue, which supports and nourishes cells that send messages from the brain to other parts of the body.

Glioblastoma

Also known as glioblastoma multiforme, this is the most common and aggressive malignant primary brain tumor in humans, involving glial cells and accounting for 52 percent of all functional tissue brain tumor cases and 20 percent of all intracranial tumors.

GBM

GBM is an abbreviation for glioblastoma multiforme.

Translational Genomics

Innovative advances arising from the Human Genome Project, applying them to the development of diagnostics, prognostics and therapies for cancer, neurological disorders, diabetes and other complex diseases

A Woman’s Final Months Told Through Twitter

The Incredible Story Of A Woman’s Final Months Fighting Brain Cancer As Told Through Her Tweets

Source: http://www.buzzfeed.com/ryanhatesthis/the-incredible-story-of-a-womans-final-months-fighting-brain

Ivy Foundation Helps Transform Healthcare

Ivy Foundation Biomedical Innovation Fund Doubles Support for U.Va. Projects Benefiting Human Health

New commitments from the Ivy Foundation and the University of Virginia School of Medicine will double the annual Ivy Biomedical Innovation Fund’s research awards for U.Va. faculty, while advancing discoveries to better diagnose and treat disease.

The Ivy Foundation Biomedical Innovation fund supports projects that involve School of Medicine faculty members and other investigators from multiple departments, schools and specialties across the University.

Since the creation of the Ivy Biomedical Innovation Fund in 2008, the Ivy Foundation has awarded $860,000 to University research collaborations that have the potential to yield leading-edge diagnostics, technology and treatments for a wide range of human health problems.

Each year, the fund awards approximately $200,000, with individual awards averaging $50,000. Beginning in 2013, the Ivy Foundation will increase its annual contribution, which will be matched by the School of Medicine to provide awards totaling $500,000 annually.

“The scope of projects funded over the past five years has been impressive,” said Dr. Robert W. Battle, who chairs the Ivy Foundation and directs U.Va.’s Adult Congenital Heart Clinic. “This research will make a real and immediate difference for patients. It’s gratifying to see the work that has been accomplished through the Ivy Foundation’s support. I look forward to seeing the impact that these added resources will make possible.”

In 2012, a record number of U.Va. researchers and clinicians applied for funding, with 28 proposals coming from U.Va.’s College of Arts & Sciences, School of Engineering and Applied Science, School of Medicine, School of Nursingand Medical Center.

Read more here: http://bit.ly/1gQalnU