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- Posted Thursday June 5, 2014
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 5, 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: [email protected].
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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, visit www.shc.org.
Press Contact:
Alice Giedraitis
Virginia G. Piper Cancer Center at Scottsdale Healthcare
480-323-1386
[email protected]
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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.
Press Contact:
Steve Yozwiak
TGen Senior Science Writer
602-343-8704
[email protected]