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Home Industry News Amgen announces positive denosumab results

Amgen announces positive denosumab results

28th July 2008

Amgen has announced the publication of positive top-line phase III clinical trial results for denosumab as a treatment for postmenopausal osteoporosis.

The study met its primary endpoint of reducing new vertebral fractures in patients and also met its secondary endpoints of reducing time to first non-vertebral and hip fractures, while adverse events in patients administered with the compound was similar to placebo.

Denosumab is a fully-human monoclonal antibody that targets the Rank Ligand regulator of cells that break down bone, known as osteoclasts.

It is being investigated as a treatment for postmenopausal osteoporosis, cancer-induced bone loss and rheumatoid arthritis, as well as for its potential to delay bone metastases.

Roger M Perlmutter, executive vice-president of research and development at Amgen, said: “This long-awaited study demonstrated that denosumab treatment both increased bone mass and reduced the risk of skeletal fractures in women with postmenopausal osteoporosis.”

He added that the company is encouraged by the magnitude and consistency of the treatment as well as being happy with the safety results for the compound.

Earlier this month, Amgen announced positive phase III clinical trial results of denosumab as a treatment for bone loss in men with non-metastatic prostate cancer undergoing androgen deprivation therapy.

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