Ethics appro for Bone Medical's Perthoxal study

Australia's Bone Medical Limited has received Ethics Committee approval to proceed to a Phase I/IIa trial for the company's second lead product for osteoporosis, Perthoxal, the firm's oral parathyroid hormone.

The study will be conducted in Brisbane, Australia, by QPharm on eight healthy, post-menopausal women. Perthoxal is expected ultimately to be approved for use in late-stage osteoporotic patients, says Bone Medical. "The positive news on Perthoxal proceeding to Phase I/IIa clinical trial is an important milestone and further validation of Bone Medical's ability to progress clinical candidates," said the firm's managing director, Troels Jordansen. "We expect to be able to initiate the trial in September 2007 and to publish results in first-quarter 2008," he added.

"As Perthoxal is using the same drug-delivery technology as the company's oral calcitonin, which has just successfully finalized Phase IIb, we are hopeful to demonstrate a biological effect and be able to progress the product to the Phase IIb trial stage later in 2008," Mr Jordansen noted.