Amgen's Denosumab MAb effective in trial

1 October 2006

USA-based biotechnology firm Amgen says that data from a Phase II study of its therapeutic antibody denosumab shows that it has potential as a treatment for bone diseases. The results, which were presented at the American Society for Bone and Mineral Research's annual meeting in Philadelphia, suggest that targeting proteins involved in the regulation of bone destruction and formation may represent an effective treatment approach for such conditions.

Densomab is a fully-human monoclonal antibody that targets the RANK Ligand, a key mediator of the function of osteoclasts cells involved in the reabsorbtion of bone. In the trial, patients who received 60mg of the agent, administered twice a year via subcutaneous injection, experienced an increase in bone mineral density when compared with the placebo group, who saw a decline from baseline levels over the program's 24 month duration (6.69% versus -0.31%; assessed using hip structural analysis).

In addition, the firm reported data from animal model trials of a sclerostin-neutralizing MAb that it is developing with Belgian biopharmaceutical company UCB. The program showed that primates receiving a 30mg/kg dose of the drug achieved a 5.5-fold increase in the rate of bone formation.

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