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- Posted Friday September 6, 2013
FDA approves drug tested by Scottsdale Healthcare and TGen
Abraxane now part of standard-of-care for patients with advanced pancreatic cancer, following studies at the Virginia G. Piper Cancer Center
SCOTTSDALE, Ariz. - Sept. 6, 2013 - The U.S.
Food and Drug Administration today approved Abraxane for patients
with advanced pancreatic cancer, following 7 years of rigorous
clinical trials overseen by Scottsdale Healthcare and the
Translational Genomics Research Institute (TGen).
Abraxane, the brand name for nab-paclitaxel, was approved for use
in combination with gemcitabine, the previous standard drug
therapy, following a large scale international clinical trial
headed by Dr. Daniel D. Von Hoff, TGen Physician-in-Chief and Chief
Scientific Officer at Scottsdale Healthcare's Virginia G. Piper
Cancer Center Clinical Trials, a partnership of Scottsdale
Healthcare and TGen.
"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, echoing the analysis he presented
earlier this year at the annual meeting of the American Society of
Clinical Oncology (ASCO). "The fact that Abraxane plus gemcitabine
demonstrated an overall survival benefit is a significant step
forward in offering new hope for our patients."
Dr. Von Hoff was the Principal Investigator of MPACT (Metastatic
Pancreatic Adenocarcinoma Clinical Trial), the Phase III clinical
study of 861 cancer patients at 121 sites in North America, Europe
and Australia.
The study found that the combination of Abraxane and gemcitabine
extended median overall survival by nearly 2 months, compared to
gemcitabine alone - extending median survival to 8.5 months, from
6.7 months. The one-year median survival of patients increased to
35 percent, from 22 percent.
"Although a two month increase in median survival may not seem
like much, it is a critical milestone and, even more important is
the significantly improved odds for patients surviving at least one
and two years. Previously very few survived one year and now
we are seeing a meaningful chance of surviving one and two
years. This brings real hope for even better outcomes in the
future for this terrible disease," said Dr. Mark Slater, vice
president of Research and chief executive of the Scottsdale
Healthcare Research Institute.
"This is a great example of Scottsdale Healthcare Research
Institute's collaborative approach of having leading researchers,
community physicians and clinical teams working together to develop
new therapies and innovative treatments that benefit patients here
in Arizona and across the United States," added Ron Korn, M.D.,
medical director of the Virginia G. Piper Cancer Center at
Scottsdale Healthcare.
Pancreatic cancer is the nation's fourth leading cause of
cancer-related death, responsible this year for an estimated 45,000
new cases, and more than 38,000 deaths. There is no method of early
detection, so pancreatic cancer patients often are not diagnosed
until their cancer is in its advanced stages. Nearly 75 percent die
within the first year of diagnosis, and fewer than 6 percent
survive more than 5 years.
"Pancreatic cancer incidence is increasing worldwide, and we are
optimistic that this will have an impact for treating advanced
pancreatic cancer," added Ramesh Ramanathan, M.D., medical director
of Virginia G. Cancer Center Clinical Trials at Scottsdale
Healthcare and MPACT principal investigator for the United
States.
Today's approval of Abraxane by the FDA as a front-line treatment
of pancreatic cancer follows years of clinical trials, including
those managed by Translational Drug Development (TD2), the
pharmaceutical-development subsidiary of TGen.
"We are proud to have helped navigate the regulatory requirements
and study protocols that helped ensure that Abraxane was not only
effective, but also safe for patients with advanced pancreatic
cancer," said Dr. Stephen Gately, President and CEO of TD2. "This
is one of the most significant advancement in the treatment of
pancreatic cancer since the FDA approved gemcitabine in
1996."
Dr. Von Hoff, considered among the nation's leading authorities on
pancreatic cancer, 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 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.
Abraxane wraps traditional chemotherapy, paclitaxel, in near-nano
sized shells of albumin, a protein that the tumor recognizes as
food. Once inside the tumor, the Abraxane acts like a "Trojan
Horse" to release chemotherapy and kill the cancer cells.
Abraxane, made by Celgene Corporation, previously was approved by
the FDA for use in the treatment of metastatic breast cancer and
advanced lung cancer.
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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. Scottsdale Healthcare is the
nonprofit parent organization of 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. For more information, visit www.shc.org.
Press Contact:
Jamie Grim
Virginia G. Piper Cancer Center at Scottsdale Healthcare
480-323-1387
[email protected]
*
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]
*
About Translational Drug Development (TD2)
Translational Drug Development (TD2) is an oncology drug
development organization and is wholly owned by the Translational
Genomics Research Institute (TGen). TD2 provides innovative
services for oncology focused biopharmaceutical companies using a
dedicated team of professionals with broad experience and
understanding in drug development. TD2 is uniquely positioned to
support the need for improved and accelerated development of new
chemical entities (NCE's) for life-threatening diseases. TD2 uses a
unique combination of experience gained through its contract
research organization business, and an integrated suite of
proprietary and non-proprietary tools, preclinical study execution,
regulatory affairs assistance, clinical trial design and
management, and drug development experts to successfully move
therapeutics towards regulatory approval. TD2 is dedicated to
reducing the risks and uncertainty inherent in the drug development
process. For more information about Translational Drug Development,
visit www.td2inc.com.
Press Contact:
Tara Franks
VP, Business Operations
602-358-8322
[email protected]
*
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global pharmaceutical company engaged primarily in the
discovery, development and commercialization of innovative
therapies for the treatment of cancer and inflammatory diseases
through gene and protein regulation. For more information, please
visit www.celgene.com.