- Posted Thursday June 5, 2014
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
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.
Virginia G. Piper Cancer Center at Scottsdale Healthcare
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.
TGen Senior Science Writer