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STUDIES OF
GROWTH HORMONE RESULT IN NEW CLASS OF
DRUGS
Contact:
- John
Kopchick, Edison Biotechnology Institute, (740) 593-4534
or e-mail kopchick@ohio.edu
- Gary
Meyer, Technology Transfer Office, (740) 593-1818,
meyerg@ohio.edu
ATHENS,
Ohio -- Studies at Ohio University of growth hormone and its
role in diabetes, acromegaly, cancer and other health
problems have resulted in the discovery of protein
antagonists that have been used to develop a new class of
drugs for the treatment of these and other diseases.
Ohio University recently received the third U.S. patent in a
series on the technology, growth hormone antagonists, which
is the basis for the development of the drug termed
pegvisomant. This summer, scientists in Texas announced the
positive results of Phase III clinical trials of pegvisomant
for the treatment of acromegaly, a disease that affects
about 40,000 people worldwide. Sensus Drug Development
Corp., the company that developed pegvisomant, plans to file
for Federal Drug Administration approval for the drug's use
in acromegaly early next year.
"Not many university professors are able to see something
discovered in their laboratory be used successfully in the
treatment of a human disorder. We are very proud of our
discovery of this new class of drugs," said John Kopchick,
Goll-Ohio Eminent Scholar and professor of molecular and
cellular biology at Ohio University. "We've discovered
something that can be used to treat human illness and save
lives."
Kopchick and former Ohio University scientist Wen Chen
discovered growth hormone antagonists just 10 years ago in
labs in the university's Edison Biotechnology Institute,
where Kopchick is a senior scientist. Human and animal
growth hormones contain a chain of 191 amino acids.
Kopchick's research team discovered that by replacing the
amino acid glycine -- number 119 in the chain in animals and
120 in humans -- with almost any other amino acid, the
growth hormone turns from a growth hormone agonist, or
enhancer, to a growth hormone antagonist, or inhibitor.
The antagonist inhibits the action of the hormone at the
cellular level by competing for receptors usually claimed by
growth hormone, thus inhibiting the biological activity of
the hormone.
Animal studies at EBI of the antagonists' effect on
acromegaly were successful, laying the groundwork for the
human trials that concluded earlier this year.
"Our antagonists inhibit growth hormone activity in
scenarios where excessive growth hormone action may be
implicated in a disease," said Kopchick, who added that his
work and studies elsewhere suggest growth hormone is
involved in the progression of diabetic kidney disease and
breast cancer. His research team now is conducting animal
studies of the growth hormone antagonists' ability to halt
the progression of diabetic nephropathy and breast
cancer.
Growth hormone's role in these diseases was not as obvious
as the hormone's role in acromegaly, which is caused by a
brain tumor that causes the pituitary gland to produce
massive amounts of growth hormone. The disease, most
commonly seen in middle-aged adults, is characterized by
abnormal growth of the hands, feet, and bone and cartilage
in the face and other parts of the body; and enlargement of
the liver, spleen, kidneys and heart.
Earlier this year, scientists with Sensus, which holds the
license for the growth hormone antagonist technology,
announced the results of Phase III clinical trials of the
growth hormone antagonist drug pegvisomant. The trials were
conducted at 16 medical centers in the United States and
Europe with 111 patients. Patients in the active treatment
groups received 10, 15 or 20 milligrams per day for 12
weeks. According to findings presented at the Endocrine
Society's annual meeting in June, pegvisomant was
well-tolerated and no major adverse events were reported
throughout the course of the study. Pegvisomant has been
granted "fast track" review by the FDA.
The latest patent issued to Ohio University and Kopchick for
growth hormone antagonists deals with the use of growth
hormone antagonist for the treatment of many diseases,
including acromegaly. The university also recently received
notice that a European patent will be issued on the
technology before the end of the year. The university
received U.S. patents on growth hormone antagonists in 1994
and 1997.
The Edison Biotechnology Institute is a biomedical genetics
institute at Ohio University and part of the Ohio Department
of Development's Thomas Edison Program. Kopchick, who holds
a faculty appointment in the College of Osteopathic
Medicine, is a recipient of the state of Ohio's Eminent
Scholar Awards.
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