OSI-906 in clinical trial for adrenocortical carcinoma
SCOTTSDALE, Ariz. - Sept. 22, 2009 - TGen Clinical Research
Services at Scottsdale Healthcare today announced the start of a
clinical trial for a drug designed to combat adrenocortical
carcinoma (ACC), a rare but deadly cancer that attacks the adrenal
glands.
TCRS is a strategic alliance between the Translational Genomics
Research Institute (TGen) and Scottsdale Healthcare.
Other than surgery, the only treatment for ACC is the exacting use
of a compound called mitotane, a chemical relative of DDT, which
the U.S. banned as an insecticide in 1972.
TCRS clinicians hope the new compound, OSI-906, developed by OSI
Pharmaceuticals Inc. of Melville, N.Y., will stop ACC tumor growth
- perhaps even promote tumor shrinkage - without the toxic side
effects of current chemotherapies. The trial will focus on patients
with inoperable tumors who have relapsed or failed to respond to
conventional therapies.
This clinical trial of OSI-906 is expected to last several years
and include 135 patients, with 30-40 enrolled at TCRS. As there is
no standard therapy available, two-thirds of the patients will
receive the drug OSI-906 while one-third receives a placebo. Sites
elsewhere in the U.S., as well as in Europe and Australia, are
expected to enroll patients over the coming months.
"The trial is major step toward helping patients with ACC, who
often face radical surgery as part of their treatment," says Dr.
Michael J. Demeure, who will oversee the trial locally. Dr. Demeure
is a TGen Senior Investigator and a Scottsdale Healthcare surgeon
experienced in removing ACC tumors.
"It's a big operation requiring a large incision because these
tumors can be the size of a football. Unfortunately many patients'
tumors have spread so we can't remove it all, so new treatments are
needed.'' said Dr. Demeure. "This unique partnership between
Scottsdale Healthcare and TGen allows us to bring the newest and
most promising treatments to patients with cancer right here in
Arizona."
The adrenal glands are responsible for making several critical
hormones, including cortisol, which the body needs in order to
respond to stress and which helps to maintain normal blood sugar
levels in children.
While use of mitotane in ACC patients reduces tumors, it also
diminishes adrenal gland function, requiring patients to take
hormone replacements for the rest of their lives. In addition,
mitotane must be administered for at least three months in order to
reach a therapeutic level. Even then, it has proved effective in
about 22 percent of ACC cases. When given with other chemotherapy
drugs, the effectiveness of mitotane may be improved, but patients
often suffer debilitating side effects.
OSI-906 is an orally available small molecule IGF-1R inhibitor that
blocks the chemical pathway that otherwise allows the ACC tumors to
grow out of control. OSI-906 is expected to have minimal impact on
the healthy tissue of the adrenal glands or their normal
function.
The TCRS clinic in the Virginia G. Piper Cancer Center at
Scottsdale Healthcare Shea is the first site worldwide approved for
these clinical trials. Patients who want to participate may contact
patient care coordinator Joyce Ingold, R.N., at 480-323-1339, toll
free at 1-877-273-3713 or at [email protected]
"Being the first site in the world for clinical trials of this drug
adds to the long list of 'firsts' for the Virginia G. Piper Cancer
Center," said Mark Slater, Ph.D., vice president of research.
"Scottsdale Healthcare's collaborations with world-class physicians
and scientists are helping pave the way for exciting new cancer
treatments to benefit patients with cancer everywhere."
Although ACC is very rare, affecting only one or two people per
million, Dr. Demeure said developing new drugs against this orphan
indication is worth the effort and expense.
"Patients with rare tumors have unique challenges. Often it is
difficult for them to find a doctor who even knows about their
disease," he said. "What we learn taking care of those patients
with ACC could help us learn how to take care of others with rare
tumors.''
The clinical trial follows nearly 3 1/2 years of research at TGen,
initiated through the efforts of patient advocate and ACC survivor,
Mr. Troy Richards.
Richards, a Scottsdale resident, has battled ACC since 1999. To
combat what little research he saw being done on the disease, he
began the Advancing Treatments for Adrenocortical Carcinoma (ATAC)
fund, which helped finance the ACC Research Program at TGen.
"The ACC project at TGen has finally given those of us with the
disease hope for better treatments, and maybe one day a cure," said
Mr. Richards. "It is my hope that this program can serve as a model
for other rare diseases, and that patients will realize they do
have the power to make a difference."
Dr. Kimberly Bussey, a TGen Associate Investigator and Lead
Investigator for TGen's Adrenocortical Carcinoma Research Program,
said, "Troy brings a sense of urgency and a connection to the ACC
patient community that made this trial possible. This is a huge
accomplishment for the ACC Research Program at TGen and a great
testament to what patient-advocated research can accomplish in a
short period of time."
"We are eagerly awaiting the opening of this study," said Dr.
Maqbool Halepota, an oncologist with the Palo Verde
Hematology/Oncology group based at the Virginia G. Piper Cancer
Center at Scottsdale Healthcare. "I firmly believe that targeted
therapies are the future of cancer care, and our partnership with
TCRS allows patients in the Phoenix area access to many innovative
trials."
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About the Virginia G. Piper Cancer Center at Scottsdale
Healthcare
The Virginia G. Piper Cancer Center at Scottsdale Healthcare offers
diagnosis, treatment, research, prevention and support 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. 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.
Press Contact:
Keith Jones, Director of Public Relations
Virginia G. Piper Cancer Center at Scottsdale Healthcare
480-882-4412
[email protected]
*
About TGen
The Translational Genomics Research Institute (TGen) is a Phoenix,
Arizona-based non-profit 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 is affiliated
with the Van Andel Research Institute in Grand Rapids, Michigan.
For more information, please visit: www.tgen.org.
Press Contact:
Steve Yozwiak
TGen Senior Science Writer
602-343-8704
[email protected]
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