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- Posted Wednesday September 2, 2009
Scottsdale Healthcare-TGen clinical trial results signal advances against skin cancer
Study data appears in New England Journal of Medicine
PHOENIX, Ariz. - Sept. 2, 2009 - Analyses of clinical trial results
published today in the New England Journal of Medicine (NEJM) shows
a potential new investigational therapy for advanced and metastatic
basal cell skin cancer.
The study, conducted at TGen Clinical Research Service (TCRS) at
Scottsdale Healthcare and two other sites appears to demonstrate
tumor shrinkage and limited side effects. TCRS is a strategic
alliance between the Translational Genomics Research Institute
(TGen) and Scottsdale Healthcare.
These findings are significant because no proven therapy exists for
advanced basal cell carcinoma (BCC). BCC is the most common cancer
in the United States with about one million new cases diagnosed
each year. Arizona has one of the highest incidences of skin cancer
in the world.
The article appears on-line today and in the Sept. 17 print issue
of NEJM.
"Until now, no treatment existed that effectively slowed tumor
growth in those patients with advanced skin cancer," said lead
investigator Daniel D. Von Hoff, MD, Physician in Chief at TGen,
Chief Medical Officer for the Scottsdale Clinical Research
Institute at Scottsdale Healthcare and chief scientific officer at
US Oncology. "By strategically initiating what we call "precision
oncology", or using the right drug for each cancer, this study
offers great potential against basal cell carcinoma and other
cancers."
The trial, sponsored by Genentech, included clinicians at TCRS, the
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
University in Baltimore, and Karmanos Cancer Institute in Detroit.
The results demonstrated that GDC-0449, a Hedgehog Pathway
Inhibitor, appears to shrink tumors in locally advanced and
metastatic BCC. Known as the "Hedgehog" trial, the clinicians
observed a durable clinical benefit -defined as tumor shrinkage
visible on X-ray or other physical exam or improvement in symptoms
without tumor growth- in 18 of 33 patients evaluated. Others had
stable disease for prolonged periods of time. Only 4 patients had
progression of disease.
Abnormal activation of the Hedgehog signaling pathway appears to be
an important mechanism for numerous types of cancer to develop,
survive, or grow. A chemical called cyclopamine found in the
California corn lily can inactivate this Hedgehog pathway.
Study investigators selected BCC as the first cancer to study in
that most BCCs have abnormalities or mutations of Hedgehog pathway
genes named PATCHED and SMOOTHENED.
"Success of this new therapy is another example of applying genetic
information to medicine. We are constantly working to improve
treatment options for patients with common and rare cancers," said
TCRS physician Glen J. Weiss, M.D., a contributing author on the
study.
Patient response to the therapy was assessed through physical
examination and imaging.
"Integrating genomic data with state-of-the-art clinical and
imaging information to develop and apply targeted therapies has
certainly taken a major step forward with the encouraging results
from the Hedgehog trial," added Dr. Ron Korn, a Scottsdale
Healthcare radiologist and director of Scottsdale Medical Imaging
Ltd.
Initial observation and isolation of cyclopamine from the corn lily
occurred in 1957. Subsequently, scientists at Genentech developed
GDC-0449 (an oral drug), which was jointly validated through a
series of preclinical studies performed under a collaboration
agreement between Genentech and Curis, Inc. (Cambridge, MA).
Genentech is a wholly owned subsidiary of the Roche Group.
Patients seeking more information on new therapies available
through either TCRS or Scottsdale Healthcare can e-mail
[email protected] or call 480-323-1339 (toll free
1-877-273-3713).
# # #
About the Virginia G. Piper Cancer Center at Scottsdale
Healthcare
The Virginia G. Piper Cancer Center at Scottsdale Healthcare offers
cancer prevention, diagnosis, treatment, research and support
services in its facilities at the Scottsdale Healthcare Shea
Medical Center, attracting patients from across Arizona and the
U.S. Groundbreaking cancer research is conducted through its
Scottsdale Clinical Research Institute and TGen Clinical Research
Service. It is a primary clinical research site for the
Translational Genomics Research Institute and the Stand Up To
Cancer Pancreatic Cancer Research Dream Team. Scottsdale Healthcare
is the not-for-profit parent organization of the Scottsdale
Healthcare Shea Medical Center, Scottsdale Healthcare Osborn
Medical Center and Scottsdale Healthcare Thompson Peak Hospital,
Virginia G. Piper Cancer Center, Scottsdale Clinical Research
Institute and Scottsdale Healthcare Foundation. For additional
information, please visit www.shc.org.
About TCRS
TGen's Clinical Research Service (TCRS), a strategic alliance with
Scottsdale Healthcare (SHC), provides a direct clinical research
site for TGen. Led by Dr. Daniel Von Hoff, TGen's
Physician-in-Chief and TCRS Chief Scientific Officer, TCRS
clinicians focus on clinical trials with targeted agents and
genomics-based individualized therapy. The TCRS, with an initial
focus on cancer, allows the unique opportunity for TGen to
transition its laboratory-based research to patient care centered
on individualized therapy. TCRS will bring new clinical research
into the community, to those patients who would otherwise have to
travel someplace else for access to new therapies or prevention
agents.
About TGen
The Translational Genomics Research Institute (TGen) is a
non-profit 501(c)(3) organization dedicated to conducting
groundbreaking research with life changing results. Research at
TGen is focused on helping patients with diseases such as cancer,
neurological disorders and diabetes. TGen is on the cutting edge of
translational research where investigators are able to unravel the
genetic components of common and complex diseases. Working with
collaborators in the scientific and medical communities, TGen
believes it can make a substantial contribution to the efficiency
and effectiveness of the translational process. TGen's vision is of
a world where an understanding of genomic variation can be rapidly
translated in a manner tailored to individual patients. For more
information about TGen, please visit www.tgen.org.
SCOTTSDALE HEALTHCARE MEDIA CONTACT:
Keith Jones, Director of Public Relations
480-882-4412
[email protected]
TGEN MEDIA CONTACT:
Steve Yozwiak
TGen Senior Science Writer
602-343-8704
[email protected]
