Amgen (NASDAQ: AMGN), the world's largest biotechnology procession, announced today the publication of Phase 2 transcript demonstrating all other year injection of denosumab (previously referred to in set of AMG 162), a RANK Ligand inhibitor, greatly increased tap limestone confidence (BMD) within the whole hip, lumbar vertebral column, distal 1/3 radius and total article compare to placebo. The grades of this one-year look defend done occur in the Feb. 23, 2006 shipping out of the New England Journal of Medicine. Data results also incorporated an open-label FOSAMAX (alendronate)* arm of imitate clinical nightmare.
Researchers report that subcutaneous injections of denosumab significantly increased BMD at the total hip from 1.9 to 3.6 percent in women who be administered the dream therapy twofold every twelve months as compared nearby a diminution of 0.6 percent in the placebo group (p0.001) at one year. The accessible allure FOSAMAX group assumption 70 mg weekly have an multiply of 2.1 percent during the same occurrence carcass. Results also indicate that denosumab had a swift beginning of undertaking. A chief decrease in serum height of C-telopeptide, a biomarker of bone resorption, be do inner 72 hours after dose.
"These breathtaking data recommend that denosumab, when administered in twice-yearly injections, may make sunny afford surety in the reporting of osteoporosis," said Michael McClung, MD, FACP, principal investigator of the denosumab study, Providence Portland Medical Center, and meter of the Oregon Osteoporosis Center, Portland, Ore. "Continued research will further our know-how of the undeveloped of denosumab in bone disadvantage obedience." Denosumab target RANK Ligand, a protein that stroke as the earlier representative of osteoclast (cells that short-term halt downhill bone) commotion. This investigational therapy be the primary RANK Ligand inhibitor in trailing stand upgrading.
Amgen is study denosumab in wish of its potential in a chunky test of terms associated with bone flattening with osteoporosis, treatment-induced bone loss, bone metastases, multiple myeloma and rheumatoid arthritis. Data lately presented at the American College of Rheumatology 2005 Annual Scientific Meeting show further increase in bone mineral density in postmenopausal women with osteoporosis after two years of treatment.
"These data reinforce the historic role that RANK Ligand inhibition show business in decreasing bone loss," said Willard Dere, MD, leader vice president of intercontinental development and chief medical officer, Amgen. "We be committed to expanding our data antagonistic denosumab with an pervasive Phase 3 clinical program to weigh against the effect of denosumab on hinder fracture in man and women." In the one-year trial results, researchers also reported twice-yearly subcutaneous injections of denosumab significantly increased lumbar spine BMD from 3.0 to 6.7 percent after 12 months as compared with a decrease of 0.8 percent in the placebo-treated patients (p0.001). Across all dose and dosing interval, distal 1/3 radius BMD increased from 0.4 to 1.3 percent as compared with a decrease of 2.0 percent in those taking placebo (p0.001), and total body BMD increased from 0.6 to 2.8 percent as compared with a decrease of 0.2 percent in the placebo group (p0.01).
The rate of adverse actions was visual overhang down the lid to among the denosumab, placebo, and FOSAMAX group, with the freedom of unsettled stomach. Dyspepsia transpire in 7 percent of placebo patients, 6 to 15 percent of denosumab patients and 26 percent of open-label FOSAMAX patients. The supreme rife adverse events among all groups included upper respiratory fog (common cold), arthralgia (joint pain), nasopharyngitis (sore throat), back distress and headache. No neutralize antibodies to denosumab were observed.
----------------------------Article adapted by finances of Medical News Today from agile pinch unbolt.
---------------------------- Denosumab Study Design This is an ongoing, multi-center dose-ranging trial. Investigators randomized 412 wholesome postmenopausal women, intermediate age 63, with dwindling BMD to receive denosumab, placebo or FOSAMAX. The aim of the study was to hum and haw on the safekeeping and efficacy of denosumab on lumbar spine BMD compared with placebo at 12 months. The doses of denosumab evaluate 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 denosumab via subcutaneous immunisation. Patients receiving FOSAMAX pursue the agreed validation and oral dosing advice of 70 mg once weekly.
At corridor, the average lumbar spine T mark range from -2.0 to - 2.2 across dose groups, the same with a diagnosis of osteopenia (thinning bone). Approximately a quarter of the patients had osteoporosis as defined by a T score identical to or down -2.5 at the lumbar spine.
About RANK Ligand Bone is unendingly formed and removed through a colloquial modus operandi of remodeling. Bone resorption is dependent on RANK Ligand, the protein that acts as the primary mediator of osteoclast conception, manoeuvre and continuation. Osteoclasts are cell to lay blame on for bone clearance.
Preclinical shining occurrence particular demonstrated that inhibit RANK Ligand significantly upgrade cortical and trabecular bone density, paperback and character. Cortical bone is the defending outer casing on all loin every bone in the body. Trabecular bone is planned as spongy bone and is encircled by the harder cortical lode.
The Need for Bone Loss Treatments Osteoporosis Bone loss signify a significant clinical and economic weigh down. Osteoporosis is a key developed condition peril for an fairly accurate 44 million Americans, or 55 percent of the population 50 years of age and elder. In the U.S. today, 10 million individuals are estimated to already have the scallywag and almost 34 million more are estimated to have low bone mass, prologue them at increased threat for osteoporosis. Of the 10 million Americans estimated to have osteoporosis, eight million are women and two million are men. In rider, one in two women and one in four men over age 50 will have an osteoporosis-related fracture in their left behind lifetime.
In Europe, recent ballpark figure have stated that nearly 3.8 million ancestors have weathered bone fractures linked to osteoporosis.
About Amgen Amgen discover, develop and deliver revolutionary human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first company to realize the unsullied science's promise by bring safe and sound and potent medicine from lab, to engineering processing plant, to lenient. Amgen therapeutics have changed the custom of prescription, helping millions of people around the world in the spar against cancer, kidney disease, rheumatoid arthritis, and other vital illnesses. With a broad and enormous pipeline of potential new medicines, Amgen sediment committed to mortgage science to dramatically improve people's in concert. To revise more about our pioneering science and our key medicines, headset in /.
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