Tag Archives: pancreatic cancer

bioscience

Pancreatic cancer drug successfully tested by TGen

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.

dan-von-hoff

TGen’s Von Hoff inducted into Joshua Lederberg Society

Dr. Daniel D. Von Hoff, Distinguished Professor and Physician-In-Chief of the Translational Genomics Research Institute (TGen), was inducted into the Joshua Lederberg Society for his work in developing the drug Abraxane for advanced pancreatic cancer patients.

The Lederberg Society is named for the late Dr. Joshua Lederberg, a Nobel Prize laureate and leader in bacterial genetics whose expertise and guidance played a key role in the birth of Celgene, a global biopharmaceutical company that produces Abraxane.

Dr. Von Hoff, who is considered among the nation’s leading authorities on pancreatic cancer, will present a talk during his induction ceremony at 1 p.m. ET today at Celgene headquarters in Summit, N.J. This is the 7th induction ceremony of the Lederberg Society, which annually honors no more than two new members whose work has changed the practice of medicine.

“Dr. Von Hoff’s life long achievements in pancreatic cancer treatment and research are truly remarkable, but even more remarkable is his commitment to the patients who benefit from his tireless efforts on their behalf,” said Dr. Jeffrey Trent, TGen President and Research Director. “I can think of no one more deserving of this award than Dr. Von Hoff.”

Dr. Von Hoff was the principal investigator of MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), a multi-year international study involving 861 patients, at 151 community and academic centers in 11 nations in North America, Europe and Australia.

The study, whose findings were published Oct. 31 in the prestigious New England Journal of Medicine, found that Abraxane (nab-paclitaxel), when combined with the previous standard therapy, gemcitabine, significantly improved overall survival, progression-free survival, and drug response rates for patients with advanced pancreatic cancer. As a result of the study, the FDA on Sept. 6 approved Abraxane as a front-line therapy for such patients. In December, the European Commission also granted its approval.

“This is a new standard for treatment of metastatic pancreatic cancer that could become the backbone for other new treatment regimens,” said Dr. Von Hoff at the time of the FDA approval. “The fact that Abraxane plus gemcitabine demonstrated an overall survival benefit is a significant step forward in offering new hope for our patients.”

Abraxane wraps traditional chemotherapy, paclitaxel, in near-nano sized shells of albumin, a protein that the tumor could recognize as food. Once inside the tumor, the Abraxane may act like a “Trojan Horse” to release chemotherapy and kill the cancer cells.

Dr. Von Hoff also was the principal investigator for the first clinical trial of gemcitabine, the first therapy to show improvement in survival for patients with pancreatic cancer. The FDA approved gemcitabine in 1996.

The pancreas is a glandular organ behind the stomach that secretes enzymes to help digestion, and produces hormones, including insulin, which helps regulate blood-sugar metabolism.

medical.research

TGen, Ventana announce research collaboration

The Translational Genomics Research Institute (TGen) and Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, today announced a collaborative research agreement to discover and develop diagnostic markers for treating cancer.

The two Arizona-based institutions will leverage each other’s expertise in discovery and diagnostic product development, bringing innovative cancer diagnostic tests to patients.

The first project under the umbrella research agreement will focus on diagnostic, prognostic and drug biomarkers for pancreatic cancer, the fourth leading cause of death from cancer in the United States. This year, an estimated 45,000 people will be diagnosed and more than 38,000 patients will die from the disease. Worldwide, more than 213,000 are diagnosed with pancreatic cancer each year, and the numbers are growing. Fewer than 1 in 4 pancreatic cancer patients survive more than a year, and fewer than 6 percent survive more than five years – the worst survival rate of any cancer.

This dismal picture of pancreatic cancer is mainly due to the lack of tools for early detection and the ineffectiveness of current therapeutics. This is why new diagnostic markers and more efficacious therapies are desperately needed.

“TGen is on the cutting edge of translational research, where investigators discover the genetic components of disease,” says Jeffrey Trent, Ph.D., President and Research Director of TGen. “Our goal is to rapidly translate basic research findings into actionable targets. Partnering with Ventana we hope will accelerate our goal to deliver meaningful discoveries to cancer patients today.”

“When a patient is faced with cancer, getting an accurate diagnosis quickly is the most important part of their treatment,” says Ventana President and CEO Mara G. Aspinall. “As the global leader in tissue-based cancer diagnostics, our strength is moving research into the clinic in order to improve the lives of all patients afflicted with cancer. We are thrilled to be able to pursue this with a partner right in our Arizona backyard.”

medical.research

Foundation donates $500,000 for TGen research

The Seena Magowitz Foundation has donated $500,000 from two charity golf tournaments dedicated to supporting pancreatic cancer research at the Translational Genomics Research Institute (TGen).

Past donations from the Seena Magowitz Foundation have helped fund significant scientific research that is making a difference in the lives of pancreatic cancer patients and their families.

In January, TGen Physician-In-Chief Dr. Daniel Von Hoff presented study results at a San Francisco cancer symposium, showing that the drug Abraxane (nab-paclitaxel) when combined with gemcitabine, significantly extended the survival of pancreatic cancer patients. The Seena Magowitz Foundation helped fund the clinical trials that led to this advance.

“A decade of advocacy and fundraising is really paying off with concrete results that are actually helping pancreatic patients survive longer,” said Roger Magowitz, President and Co-Founder of the Seena Magowitz Foundation. “Our supporters deserve to take a bow, because the research behind these advances might not be possible without their help.”

Pancreatic cancer is the fourth-leading cause of cancer death in the U.S. and annually takes the lives of more than 38,000 Americans. A staggering 75 percent of those diagnosed die within the first year, and only 6 percent survive more than five years.

The most recent $500,000 donation to TGen from the Seena Magowitz Foundation represented funds raised during the 10th annual Seena Magowitz Golf Classic on Dec. 8 at the Arizona Biltmore Resort, and also from the 3rd annual Atlanta Golf Classic, organized Oct. 1 by pancreatic cancer survivor Howard Young, President of General Wholesale Beer Company. Young is a TGen Foundation Board Member and Chairman of TGen’s National Advisory Council for Pancreatic Cancer Research.

“TGen could not have made the progress we have against this disease without the unflagging dedication of special people like Roger Magowitz and Howard Young, and the hundreds of supporters they have inspired over the past decade,” said TGen Foundation President Michael Bassoff.

Magowitz informed the TGen Foundation of the $500,000 donation during the March 28 Evening on the Diamond, an annual fundraising event hosted by the Arizona Diamondbacks at Chase Field.

“We are experiencing a remarkable confluence of forces between the Seena Magowitz Foundation, Major League Baseball and TGen in the fight against this most aggressive and deadly of cancers,” Magowitz said. “It is this kind of concerted effort, backed by prominent individuals and organizations, that eventually will lead to a cure for pancreatic cancer.”

Evening on the Diamond included the presentation of the Arizona Diamondbacks Foundation Community Leadership Award, now named in memory of Lee Hanley, the late TGen Foundation Board Member who passed away in 2012 from pancreatic cancer. The newly named Lee T. Hanley Community Leadership Award was presented to former Arizona Sen. Jon Kyl for his 26 years of service in the U.S. Congress. Past winners include TGen Board Chairman Bill Post, TGen Foundation Board Member Karl Eller, and TGen President and Research Director Dr. Jeffrey Trent.

Singer-songwriter and multi-instrumentalist Alyssa Bonagura, who performed Dec. 8 during the 10th annual Seena Magowitz Golf Classic, also performed during Evening on the Diamond.

In March, Brian Cashman, Senior Vice President and General Manager of the New York Yankees, at the invitation of D-backs President and CEO Derrick Hall, joined TGen’s National Advisory Council for Pancreatic Cancer Research. Both MLB officials’ fathers died from the disease, and Hall was master of ceremonies at the Seena Magowitz Golf Classic.

Major sponsors of the golf tournament include: Leggett & Platt, Mattress Firm, Sealy, Mattress Discounters, Sleep Inc., Serta, Comfort Revolution, Ellman Family Vineyards, General Wholesale Beer Company, Morley Company, Simmons, Raymond James, Customatic, and the Arizona Diamondbacks.

Roger Magowitz founded the Seena Magowitz Foundation in honor of his mother, Seena, who died of pancreatic cancer in 2001.

Tony Pena, Brian Cashman

Yankees’ GM supports TGen Research

A top official of the New York Yankees whose father passed from pancreatic cancer has joined a prestigious national panel organized by the Translational Genomics Research Institute (TGen) to fight this aggressive disease.

Brian Cashman, Senior Vice President and General Manager of the vaunted Yankees Major League Baseball franchise, has joined TGen’s National Advisory Council for Pancreatic Cancer Research.

TGen’s National Advisory Council leads a critically needed funding effort and promotes a deeper public understanding of pancreatic cancer, the nation’s fourth-leading cause of cancer death, which in 2012 took the lives of nearly 44,000 in the U.S. and nearly 235,000 worldwide.

Cashman lost his father, John, in September after a 10-month battle with pancreatic cancer. He had wanted his Yankees to reach the World Series as one last gift to his father.

“My father loved the Yankees. There are a lot of people who face these kinds of challenges, and they look to the Yankees to provide positive inspiration. For my father, the Yankees were always something he could look forward to,” he said. “I welcome the responsibilities and challenges of my role in the fight against pancreatic cancer. I have a personal experience to draw from, and coupled with my unique standing within the fabric of baseball, I’d like to believe I can make the type of contribution my father would be proud of.”

Cashman was invited to join TGen’s National Advisory Council by another council member, Arizona Diamondbacks President and CEO Derrick Hall, who in 2011 lost his father, Larry, to pancreatic cancer, even as Derrick was fighting his own battle with prostate cancer.

The Yankees and Diamondbacks played one of the game’s iconic 7-game World Series in 2001.

In addition to Cashman and Hall, another MLB official, David Dombrowski – President, CEO and General Manager of the Detroit Tigers – also is a member of the National Advisory Council for Pancreatic Cancer Research.

Other members of TGen’s National Advisory Council are: Raymond Bojanowski, Co-founder and Co-chairman of the Seena Magowitz Foundation; Karl Glassman, Chief Operating Officer and Executive Vice President of Leggett & Platt Inc.; Diane Halle,
President of the Bruce T. Halle Family Foundation and the Herbert K. Cummings Charitable Trust; Steve Hilton, Chairman and Chief Executive Officer of Meritage Homes Corp.; David Lane, President of the Lane Affiliated Companies; Roger Magowitz, President and Founder of the Seena Magowitz Foundation; Vincent McBeth, President of the The McBeth Group International and a retired U.S. Navy Commander; Larry Rogers, President and CEO of the Sealy Corp.; Steve Stagner, President and CEO of the Mattress Firm; Louis A. “Chip” Weil III, retired Chairman, President and CEO of Central Newspapers Inc.; and Howard Young, President of the General Wholesale Company.

“Brian Cashman is a powerful addition to TGen’s National Advisory Council. His personal experience, championship reputation, and national visibility will be a huge boost to TGen’s fight against pancreatic cancer,” said Michael Bassoff, TGen Foundation President.

Cashman joined the Yankees as a 19-year-old intern and now commands one of the most demanding jobs in sports. During 25 seasons, he has earned five World Series rings. At age 30, he became the youngest GM to win a World Series. And during 1998-2000 he became the only GM in Baseball history to win World Series titles in each of his first three seasons.

clinical research advantage - vaccines

TGen, Scottsdale Healthcare study may help pancreatic cancer patients

A multi-center Phase III clinical trial demonstrates that Abraxane (nab-paclitaxel) plus gemcitabine is the first combination of cancer drugs to extend survival of late-stage pancreatic cancer patients compared to standard treatment.
The MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study was led by physicians from Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials, a partnership between Scottsdale Healthcare and the Translational Genomics Research Institute (TGen).

Their findings show that Abraxane plus gemcitabine was well tolerated and resulted in clinically meaningful outcomes compared to gemcitabine alone, the current standard of care. The study abstract was released today and the data will be presented at the American Society of Clinical Oncology (ASCO) 2013 Gastrointestinal Cancers annual meeting Jan. 25 in San Francisco.

“We are ecstatic that this clinical trial of Abraxane plus gemcitabine improves survival for patients with advanced stage IV pancreatic cancer,” said Dr. Daniel Von Hoff, international lead investigator for MPACT, chief scientific officer for Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare, and TGen’s Physician-In-Chief. “It once again demonstrates that laboratory science based medicine can make a difference for patients.”

MPACT is the largest phase III clinical trial completed in advanced pancreatic cancer with more than 800 patients. Findings from the study showed a 59 percent increase in one-year median survival rates from less than a quarter of the patients (22 percent) to more than a third (35 percent). The two-year survival rate for this cancer is negligible, less than 4 percent, but that more than doubles (9 percent) with the nab-paclitaxel/gemcitabine combination.

One of those patients was Lynne Jacoby, 48, of Phoenix, who works as a director of compliance for a healthcare company. Jacoby was given only weeks to live when her Stage 4 pancreatic adenocarcinoma, a tumor the size of a golf ball, was first diagnosed in April 2012 — nine months ago.

“If you had to live your life in a year, and that is all the time you have, wouldn’t you do everything you could to experience this time,” said Jacoby, who for nearly a year before her diagnosis had experienced night sweats, indigestion, stomach pains, neck and back pain, and an elevated white-blood count.

She began the treatment of Abraxane plus gemcitabine in May 2012 and continues on the medications, saying now that she “feels awesome, wonderful.” She is scheduled to remain on the drug combination through May 2013.

“Life is priceless. No amount of money can be placed on life. I know I would be gone already if it was not for Dr. Von Hoff,” said Jacoby, who also refers to him as “Dr. Von Hope.”

The study showed significant improvement among some of the sickest patients including those with increased metastases. Significantly there was no increase in life-threatening toxicity. Other drug combinations that have demonstrated benefit have been limited by increased toxicities.

“This is a major improvement in a cancer with the lowest survival rates among all cancer types,” said Dr. Ramesh Ramanathan, medical director of Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare and principal investigator for the clinical trial in the United States. “Advanced pancreatic cancer is fourth most common cause of cancer death in the United States and throughout the world. It is difficult to diagnose with a majority of the cases diagnosed at a late stage after the disease has already advanced.”

Abraxane wraps traditional chemotherapy, paclitaxel, in near-nano sized shells of albumin, a protein that the tumor sees as food. The tumor uses various mechanisms to preferentially attract the albumin, which then acts like a “Trojan Horse” to release its package of chemotherapy inside the tumor. It is approved in the U.S. for metastatic breast cancer and non-small cell lung cancer.

The pancreas is a gland behind the stomach that secretes enzymes into the upper part of the small intestine to help digestion. It also produces hormones, including insulin, which helps regulate the metabolism of sugars.

The incidence of pancreatic cancer is increasing worldwide with an estimated 279,000 cases per year, including nearly 44,000 in the U.S. in 2012, and resulting in more than 37,000 American deaths last year.

Individuals seeking information about eligibility to participate in clinical trials at the Virginia G. Piper Cancer Center at Scottsdale Healthcare may contact the cancer care coordinator at: 480-323-1339; toll free at 1-877-273-3713; or via email at clinicaltrials@shc.org.

medical.research

TGen, Scottsdale Healthcare lead pancreatic cancer study

A new cancer drug combination demonstrated significant improvement in overall survival of late-stage pancreatic cancer patients compared to those receiving standard treatment, according to results of a Phase III clinical trial led by physicians from Scottsdale Healthcare’s Virginia G. Cancer Center Clinical Trials, a partnership with the Translational Genomics Research Institute (TGen).

Physicians at the Virginia G. Piper Cancer Center at Scottsdale Healthcare were first to design a clinical trial to determine the safety, tolerability and effectiveness of nab-paclitaxel (Abraxane) in combination with the standard drug gemcitabine in patients with advanced pancreatic cancer. Results of that multicenter study chaired by Dr. Daniel Von Hoff were encouraging enough that it led to one of the largest international studies ever done in pancreatic cancer, with 861 patients.

Full results are expected to be presented at the American Society of Clinical Oncology (ASCO) 2013 Gastrointestinal Cancers Symposium in Jan. 24-26 in San Francisco.

“This is a great example of rapid bench to bedside development of new treatments for cancer. We’re ecstatic that we will have a new treatment for patients with late stage pancreatic cancer,” said Dr. Von Hoff, international lead investigator and Chief Scientific Officer for the Virginia G. Cancer Center Clinical Trials at Scottsdale Healthcare and TGen’s Physician-In-Chief.

The pancreas is a gland behind the stomach that secretes enzymes into the upper part of the small intestine to help digestion. It also produces hormones, including insulin, which helps regulate the metabolism of sugars. Advanced pancreatic cancer is fourth most common cause of cancer death in the United States and throughout the world. It is a difficult to diagnose and treat cancer with the lowest survival rates among all cancer types.

Nab-paclitaxel (Abraxane) is an albumin-bound formulation of paclitaxel, produced by Celgene Corp. Dr. Von Hoff said that results of the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study will lead Celgene to submit for FDA approval.

“Pancreatic cancer incidence is increasing worldwide with almost 220,000 cases per year, and we are optimistic that this will have worldwide impact for treating advanced pancreatic cancer,” added Dr. Ramesh Ramanathan, Medical Director of Virginia G. Cancer Center Clinical Trials at Scottsdale Healthcare and principal investigator for the United States.

Dr. Von Hoff credited the support of Scottsdale Healthcare Foundation, Stand Up to Cancer and the Seena Magowitz Foundation for advancing the study at the Virginia G. Piper Cancer Center at Scottsdale Healthcare. He noted that TGen and International Genomics Consortium scientists in collaboration with scientists from Abraxis Bioscience found that in pancreatic cancer, an albumin-binding protein called SPARC was present at high levels in cells within the pancreatic tumor microenvironment. They hypothesized that the albumin formulation of nab-paclitaxel may be taken up by tumor and surrounding cells with high SPARC expression.

Individuals seeking information about eligibility to participate in clinical trials at the Virginia G. Piper Cancer Center at Scottsdale Healthcare may contact the cancer care coordinator at 480-323-1339; toll free at 1-877-273-3713 or via email at clinicaltrials@shc.org.

Lee Hanley - Vestar

Vestar's Hanley, 70, Dies Of Pancreatic Cancer

Lee T. Hanley, CEO of  Vestar Development, one of the largest privately held shopping center companies in the Western U.S., died Sunday. He was 70. The cause was pancreatic cancer.

Hanley spent more than three decades in the industry and was regarded by many as an icon in the development community. Under his leadership, Vestar, which Hanley and several other founders spun off from a home building company in the late 1980s, became a dominant player in its metro area and the Los Angeles and San Diego markets. The company has undertaken some of the most challenging, yet innovative and ultimately successful open-air projects in the country, starting with the development in 1989 of Arizona’s first power center, the former Scottsdale Pavilions.

Vestar negotiated a land lease with the Salt River Pima-Maricopa Indian Community to develop the 1.1 MSF center on about 100 acres owned by the sovereign tribe. The center attracted major retailers because of its proximity to Scottsdale.

By incorporating lakes, waterfalls and other design elements that were relatively new to shopping centers, Vestar set out to create a sense of place at Scottsdale Pavilions, and that remains a mission for the company with its projects today. (The center is now owned by Phoenix-based De Rito Partners Development Inc. and has been renamed The Pavilions at Talking Stick.)

Born in Los Angeles, Hanley graduated from the University of Arizona with a degree in accounting and served as an officer in the U.S. Marine Corps, including duty in the Vietnam War. Early in his career, he worked for the Xerox Corp., rising to become one of its top salesmen in the West, and for brokerage firm CB Commercial, the predecessor to CBRE Group Inc. In 1977, he was recruited by the former Estes Homes of Tucson to start its commercial development division, which built centers as amenities for its master-planned communities.

In the late ’80s Estes was seeking to raise cash to pay down debt, and Hanley spearheaded a buyout of his division in partnership with three colleagues, Richard J. Kuhle, David J. Larcher and J. Paul Rhodes, all of whom remain with Vestar. The acquisition was partially funded by the pension plan of the former Ameritech Corp., one of the seven so-called Baby Bells created as a result of the breakup of AT&T in 1984. Ameritech was eager to expand its portfolio of real estate investments in the West and became a capital partner to Vestar, giving it a competitive advantage over other developers during the credit crunch and recession of the late ‘80s and early ‘90s.

During that period, Vestar made its move into the highly competitive Southern California market, acquiring properties and securing entitlements for projects in places where other developers had tried to no avail. Its first ground-up project in the state was Cerritos Town Center, a 600,000 SF power center that brought one of the first Wal-Mart stores to the Los Angeles area. Vestar sold the center in early 2012.

Rick Hearn, Vestar’s director of leasing, says Hanley was a mentor who led by example. Hanley inspired him and many others at Vestar to get involved in politics, charitable causes and professional organizations.

“I consider myself blessed to have had a mentor like Lee,” says Hearn, one of many longtime Vestar employees. “He left his mark on a lot of different organizations.”

Hanley was involved in numerous other organizations. He was a trustee of the Urban Land Institute and the Barrow Neurological Foundation, which raises funds for the Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center in Phoenix. He also served on the board of the TGen Foundation, which raises funds to support the Translational Genomics Research Institute, a non-profit biomedical research institute in Phoenix.

He was active in the Greater Phoenix Leadership council, the Valley of the Sun United Way and other organizations in the Phoenix area.

Hanley and his wife Nancy were married for more than 40 years and had three children and seven grandchildren.