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- Posted Monday October 26, 2015
FDA approves new therapy for pancreatic cancer patients
International clinical trial led by TGen and HonorHealth showed significant overall survival rates
SCOTTSDALE, Ariz. (October 26, 2015) - Patients
with advanced pancreatic cancer now have access to the new FDA
approved drug, Onivyde, that produced significant overall survival
rates in an international clinical study conducted in part by
researchers at HonorHealth Research Institute and the Translational
Genomics Research Institute (TGen).
"Results from our clinical trial research showed a patient
survival rate of nearly two more months without decreasing the
quality of life compared to the other treatments tested, " said
Gayle Jameson, principal investigator, NAPOLI-1 study and associate
investigator, HonorHealth Research Institute. "Invariably
pancreatic cancer progresses at some point and we don't have a
universal standard of what to do next. In this disease, two
months of survival is a game changer for treating advanced
pancreatic cancer and gives patients hope."
Each year in the U.S., nearly 49,000 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 less than 10
percent survivor more than five years.
Onivyde will be used as part of a combination regimen with a
two-drug chemotherapy. It was approved to treat patients with
pancreatic cancer that progressed after treatment with a different
chemotherapy.
"As part of the team of medical researchers who studied the
effectiveness of MM-398 plus 5-FU and leucovorin drug combination,
we are thrilled that the FDA has approved the drug for use in
patients throughout the nation," said Dr. Daniel D. Von Hoff, MD,
FACP, global principal investigator of the NAPOLI-1 study, Chief
Scientific Officer for HonorHealth Research Institute and
Physician-In-Chief and Distinguished Professor at TGen.
The large, randomized clinical trial that evaluated the new drug,
the NAPOLI-1 (NAnoliPOsomaL Irinotecan), was sponsored by Merrimack
Pharmaceuticals. It evaluated patients enrolled at more than 100
sites in North America, South America, Europe, Asia and Australia,
including patients at HonorHealth Research Institute. The 417
patients in the study all had metastatic pancreatic cancer that was
previously and treated with the traditional standard-of-care,
gemcitabine-based therapy.
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.
Patients seeking information about research studies may contact
the HonorHealth Research Institute at 480-323-1339 or toll free at
1-877-273-3713, or email [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 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 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. Follow TGen on Facebook, LinkedIn and Twitter @TGen.
Press Contact:
Steve Yozwiak
TGen Senior Science Writer
602-343-8704
[email protected]
About HonorHealth:
HonorHealth is a non-profit health system serving an area of 1.6
million people in the greater Phoenix, Arizona area. The
network encompasses five acute care hospitals, an extensive medical
group, outpatient surgery centers, a cancer center, clinical
research, medical education, two foundations and community services
with approximately 10,500 employees, 3,700 affiliated physicians
and 3,100 volunteers. HonorHealth was formed by a merger
between Scottsdale Healthcare and John C. Lincoln Health Network.
HonorHealth's mission is to improve the health and well-being of
those we serve. Learn more at HonorHealth.com.
Media Contacts:
Alice Giedraitis
HonorHealth Media Relations Manager
480-316-4703
[email protected]