Two New Therapies Show Promise for Cancer Patients
Clinical trial data and cutting-edge testing give key insights in the fight
against basal cell carcinoma and pancreatic cancer.
San Diego and Phoenix-April 15, 2008-Clinical researchers at Scottsdale
Healthcare and TGen today announced the results of two clinical trials that
show promise for patients battling cancer.
The Phase I clinical trial findings, presented at the this weeks Annual
Meeting of the American Association for Cancer Research by Daniel Von Hoff,
MD, FACG, focused on basal cell carcinoma (BCC) and pancreatic cancer. The
Arizona trials were conducted at TGen's Clinical Research Service (TCRS) at
Scottsdale Healthcare, a strategic alliance between TGen and Scottsdale
Healthcare's Clinical Research Institute.
Basal Cell Carcinoma In the first trial, a novel molecule, GDC-0449, shrinks
tumors in basal cell carcinoma (BCC) while having limited side effects,
including a loss of sense of taste, and a small amount of hair loss and
weight loss, suggesting a viable new treatment option. GDC-0449 works by
blocking a pathway - a series of chemical reactions within a cell- known as
Hedgehog, containing two genes (PTCH and SMO) that lead to a known
tumor-promoting gene called GLI1. Alterations in any of these genes have
been shown to lead to basal cell carcinoma and other diseases. GDC-0449 is a
chemical synthetic designed to replicate the properties of cyclopamine, a
chemical found in nature.
"Basal cell carcinoma affects about one million people a year and a
proportion of these patients have disease that is not curable with surgery.
We currently do not have any treatments that can effectively slow tumor
growth in these advanced patients. This finding has potential importance in
this population," said Daniel D. Von Hoff, M.D., Physician in Chief at the
Translational Genomics Research Institute (TGen) and Chief Medical Officer
for the Scottsdale Clinical Research Institute at Scottsdale Healthcare.
Typically diagnosed with a simple biopsy, the risk of BCC increases for
those individuals with a family history, or prolonged exposure to
ultraviolet (or UV) rays from the sun. While BCC has an extremely low rate
of metastasis, it can lead to scarring and disfigurement if left untreated.
The trial results showed durable clinical benefit -defined as tumor
shrinkage visible on X-ray or other physical exam or improvement in symptoms
without tumor growth- was observed in eight out of the nine patients
evaluated.
The first patient treated in the trial has shown clinical improvement for
approximately 450 days and is ongoing, Von Hoff says, with almost no side
effects beyond minimal hair loss.
"He came to us short of breath and in pain, but he has had a very dramatic
response with this drug," Von Hoff said.
Further evaluations of the study participants measured the presence of GLI1
in skin cells sampled from the participants. Among all patients tested to
date, there was reduction in this marker, indicating that the drug was
affecting the hedgehog pathway.
The trial, sponsored by Genentech, also included clinical sites at the
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University,
Baltimore, Maryland and Karmanos Cancer Institute, Detroit, Michigan.
Pancreatic Cancer In the second trial, Von Hoff and colleagues showed that a
novel combination of two drugs (nanoparticle albumin-bound paclitaxel, or
"nab-pacilitaxel" and gemcitabine) showed a significant clinical benefit in
more than 80 percent of pancreatic cancer patients. "Unfortunately, most
patients with pancreatic cancer have a very poor survival, and until now,
the only option has been gemcitabine alone or in combination with
erlotinib," said Von Hoff.
The researchers utilized the Target NowT tumor profiling analysis, a
cutting-edge oncology testing service performed by Caris Dx and Caris MPI,
to better understand the characteristics expressed in patient's tumors. In
this ongoing research program, Von Hoff and colleagues found the SPARC
(Secreted Protein Acidic and Rich in Cysteine) protein to be commonly found
in pancreatic cancer specimens. The SPARC protein is being investigated by
Abraxis BioScience in this trial as a potential target for nab-paclitaxel. A
test for SPARC, developed at Abraxis and Caris MPI and applied by Caris MPI
under contract with Abraxis, was utilized to analyze SPARC in the pancreatic
cancer patients in the trial.
The finding of SPARC protein in pancreatic cancer patients, also described
by other investigators, was the basis for this phase I clinical trial that
Von Hoff presented at AACR.
"Chemotherapy often means combining more than one drug, and we do not want
to just take the next thing off the shelf. We want to know as much about a
tumor as possible going in," Von Hoff said.
Researchers reported on the first 20 patients of what will eventually be a
42-patient trial.
"This was a phase I trial, and phase I trials are usually designed to test
safety, hoping it will also determine efficacy. The fact that we saw this
kind of activity in a phase I trial is dramatic," Von Hoff said.
"The rationale behind the combination of Gemcitabine plus Abraxane was based
on careful science and was designed and executed by some of the leading
experts in pancreas cancer in the world. While the data is preliminary and
longer follow-up will be important, the biochemical and radiographic
responses look very encouraging", says Dr. Laheru of Johns Hopkins Kimmel
Cancer Center.
The trial, sponsored by Abraxis BioScience, also included clinical sites at
South Texas Oncology and Hematology, P.A., San Antonio, Texas, University of
Alabama at Birmingham, Birmingham, Alabama, and the Sidney Kimmel
Comprehensive Cancer Center at Johns Hopkins University, Baltimore,
Maryland.
About Abraxis BioScience Abraxis BioScience is a fully integrated global
biotechnology company dedicated to the discovery, development and delivery
of next-generation therapeutics and core technologies that offer patients
safer and more effective treatments for cancer and other critical illnesses.
The company's portfolio includes the world's first and only protein-bound
nanoparticle chemotherapeutic compound (ABRAXANE), which is based on the
company's proprietary tumor targeting technology known as the nabT platform.
The first FDA approved product to use this nabT platform, ABRAXANE, was
launched in 2005 for the treatment of metastatic breast cancer. Abraxis
trades on the NASDAQ Global Market under the symbol ABBI. For more
information about the company and its products, please visit
http://www.abraxisbio.com/.
About Caris Caris Dx provides world-class surgical pathology services to
physicians who treat patients in an ambulatory setting. The company provides
academic-caliber medical consults through its industry-leading team of
subspecialty fellowship and expert-trained pathologists in gastrointestinal
and liver pathology, hematopathology and dermatopathology. Caris Diagnostics
provides the highest levels of service to its customers and their patients
through its state-of-the-art laboratories; proprietary, advanced clinical
and technology solutions; and rigorous quality assurance programs.
Caris MPI is a leading molecular diagnostic company that provides
world-class genomic and proteomic analysis in the field of oncology and
other complex diseases. Caris MPI translates the latest discoveries made in
the research lab to patient care. Furthermore, the Tissue Banking and
Analysis Center (TBAC) at Caris MPI assists pharmaceutical companies and
researchers in their clinical trials for tissue procurement, preservation of
key analytes for cutting edge genomic and proteomic analysis and reporting
by CMPI.
About Scottsdale Healthcare Scottsdale Healthcare's vision is Setting the
Standard for Excellence in Personalized Healthcare. Established in 1962,
Scottsdale Healthcare is the not-for-profit parent organization of the
Scottsdale Healthcare Osborn, Scottsdale Healthcare Shea and Scottsdale
Healthcare Thompson Peak hospitals, Virginia G. Piper Cancer Center,
Scottsdale Clinical Research Institute, Scottsdale Healthcare Home Health
Services and Scottsdale Healthcare Community Health Services. Based in
Scottsdale, Arizona, Scottsdale Healthcare is governed by a volunteer board
of directors composed of leading local citizens. http://www.shc.org/
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 http://www.blogger.com/www.tgen.org.
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Labels: Cancer Therapies, Cancer Therapy, Cancer treatment, Scottsdale Healthcare, Tgen
