Phase 2 One Year Trial Results in Postmenopausal Women Released at
American Society for Bone and Mineral Research Annual Meeting
SEATTLE--(BUSINESS WIRE)--Oct. 3, 2004--
Amgen Inc. (Nasdaq:AMGN), the world´s largest biotechnology
company, today announced that at all doses studied, twice yearly
injections of AMG 162, the company´s investigational therapy for bone
loss, significantly increased bone mineral density (BMD) at the total
hip compared with placebo at 12 months. AMG 162, at all doses, also
increased total hip BMD, similar to or greater than that resulting
from FOSAMAX(R) (alendronate)(a) treatment in the same time frame.
The one year results of the ongoing multi-center, Phase 2 dose
ranging trial in healthy postmenopausal women with low BMD were
presented at the American Society for Bone and Mineral Research
(ASBMR) 26th Annual Meeting in Seattle. The double blind trial was
designed to evaluate the safety and efficacy of AMG 162 compared with
placebo with an open label cohort comparison to FOSAMAX(R).
"This study suggests that AMG 162 significantly improves bone
mineral density in postmenopausal patients experiencing bone loss,"
said Michael McClung, M.D., FACE, principal investigator of the AMG
162 study and founding director of the Oregon Osteoporosis Center in
Portland. "The medical community should be very encouraged by these
data that suggest AMG 162, when administered twice a year, may offer a
promising alternative for the treatment of osteoporosis."
"With the development of AMG 162, Amgen scientists have validated
an entirely new pathway and novel mechanism of action for addressing
conditions associated with bone loss," said Beth Seidenberg, M.D.,
chief medical officer and senior vice president of global development,
Amgen. "These Phase 2 results with our investigational agent are very
compelling and give us great confidence as we actively enroll and
initiate our pivotal trial."
The effects of AMG 162 (at 60 mg twice yearly) at the total hip
BMD were significantly (p less than 0.001) greater than FOSAMAX(R) (at
70 mg once weekly) at 12 months. AMG 162 across all doses and dosing
intervals increased the BMD of the lower spine by 4 to 7 percent,
similar to the 5 percent increase in the FOSAMAX(R) group, after 12
months of treatment. AMG 162 also had a positive effect on BMD at the
hip, distal 1/3 radius and total body.
In this trial, AMG 162 was well-tolerated. The most common adverse
event in any of the treatment groups was dyspepsia (4 percent, 5
percent and 20 percent in the placebo, AMG 162 and the open label
FOSAMAX(R) groups, respectively).
The company recently announced the initiation of a pivotal Phase 3
study of AMG 162 in postmenopausal women with osteoporosis. Ongoing
investigations of AMG 162 are also evaluating treatment-induced bone
loss, rheumatoid arthritis (RA) and bone metastases.
About AMG 162
AMG 162 is an investigational, fully human monoclonal antibody
with a unique mechanism of action that exclusively targets and binds
with high affinity to, and inhibits the activity of human RANK
(receptor activator of nuclear factor kappa B) Ligand, the primary
mediator of bone resorption. Amgen scientists have confirmed the
essential role of RANK Ligand pathway in the formation, activation and
survival of osteoclasts, the cells that are associated with bone
RANK Ligand is responsible for osteoclast-mediated bone loss in a
range of conditions including osteoporosis, treatment-induced bone
loss (bone loss due to glucocorticoid treatment and
immunosuppression), rheumatoid arthritis, bone metastases and multiple
myeloma. The body naturally produces a protein called osteoprotegerin
(OPG) to modulate the effects of excess RANK Ligand. OPG acts as a
decoy receptor, preventing RANK Ligand from binding to its receptor,
RANK, on the surface of osteoclasts and osteoclast precursors. By
binding to RANK Ligand, OPG prevents the formation and activation of
osteoclasts and helps keep the bone loss process in check. Amgen
developed AMG 162 to mimic the effects of OPG, enhancing the body´s
own process to specifically inhibit the effects of RANK Ligand.
Observations from pre-clinical studies confirm that inhibition of
RANK Ligand activity demonstrates significantly greater effects on
blocking bone resorption compared to other therapies. The preclinical
studies also showed that inhibition of RANK Ligand resulted in
improvements in bone mass, bone density and bone strength, indicating
that bone quantity and quality were improved. These studies, conducted
by Amgen, also documented that inhibition of Rank Ligand activity does
not interfere with the function of osteoblasts, the cells involved in
AMG 162 Study Design
Investigators randomized 411 postmenopausal women, average age 63,
with low lumbar spine BMD to receive AMG 162, placebo or FOSAMAX(R).
The primary endpoint of the study was to determine the safety and
efficacy of AMG 162 on lumbar spine BMD compared with placebo. A
secondary endpoint evaluated the cohort of patients randomized to
receive open label FOSAMAX(R). The doses of AMG 162 evaluated included
6, 14 or 30 mg every three months or 14, 60, 100 or 210 mg every six
months. The researchers administered all doses of AMG 162 via
subcutaneous injection. Patients receiving FOSAMAX(R) followed the
approved indication and oral dosing instructions of 70 mg once weekly.
At entry, the women averaged -2.2 +/- 0.8 on their T scores, an
X-ray-based rating of BMD in which scores between -1.0 and -2.5
indicate osteopenia (thinning bone) and below -2.5 indicate
osteoporosis, according to the World Health Organization (WHO).
Osteoporosis is a disease characterized by low bone mass and
structural deterioration that causes bones, most commonly of the hip,
wrist and spine, to become brittle and susceptible to fracture.
Approximately 200 million women worldwide suffer from osteoporosis,
according to the International Osteoporosis Foundation. An
osteoporosis-related hip fracture may limit mobility and lead to a
loss of independence. A vertebral fracture can result in loss of
height and stooped posture, as well.
Amgen is a global biotechnology company that discovers, develops,
manufactures and markets important human therapeutics based on
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CONTACT: Amgen, Thousand Oaks
Andrea Rothschild, 805-447-4587 (media)
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SOURCE: Amgen Inc.