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Amgen 2006 Annual Report 18
With denosumab, we aim to help
cancer patients affected by bone
metastases and bone loss.
Denosumab, a late-stage program in the Amgen pipeline, has
already received significant attention from the scientific and
medical community as a potentially promising novel treatment
for osteoporosis. What is less known is that denosumab is also
being studied for its potential to help in the treatment of bone
metastases and therapy-induced bone loss.
Denosumab is a fully human monoclonal antibody that targets
RANK Ligand, a primary mediator of the formation, function
and survival of osteoclasts (cells that break down bone).
Denosumab is the first therapy in late-stage development that
targets RANK Ligand.
Bone metastases: a painful problem in many cancers
Bone metastases or bone lesions are often seen in many of
the more common forms of cancer, such as breast, lung and
prostate cancers. They may occur when cancer cells from a
primary tumor enter the bloodstream, reach the bone marrow
through blood vessels and migrate to bone tissue, where they
settle and grow. Once tumor cells have settled in bone, they
secrete growth factors that stimulate RANK Ligand production,
promoting increased bone breakdown. Bone metastasis is one
of the most frequent causes of pain in people with cancer and
can prompt skeletal-related events such as fractures, surgery
and radiation to bones, and other complications.
Amgen has large-scale studies underway to evaluate whether
denosumab treatment would slow bone breakdown in already
cancerous bone; the interim results have been encouraging.
While these trials are studying denosumab as a way to
intervene in already-present bone metastases, other trials are
also evaluating the potential for denosumab to actually prevent
them. The action of RANK Ligand may be important in the
tissue-specific migration of some cancer cells to bone.
We are encouraged by our initial research findings,
says Guy Buckland, global commercial leader of the oncology
program for denosumab.
Osteoporosis studies moving forward
Amgen also continues to conduct several large-scale studies
of denosumab in the treatment of postmenopausal osteoporosis.
In 2006, three-year data from an ongoing phase 2 dose-finding
study yielded encouraging results.
“We are excited by the potential of denosumab to treat a
broad range of bone loss conditions,” says George Morrow,
executive vice president, Global Commercial Operations.
“If the data continue to look promising, we will look forward to
working together with health care providers to provide this new
therapy for patients.