Bone Medical completes Phase I Perthoxal osteoporosis trial

Bone Medical (ASX:BNE) has completed a Phase I trial of its oral parathyroid hormone (PTH) product Perthoxal under development for the treatment of osteoporosis.

The trial, which involved 18 post-menopausal women, was conducted at the Clinical Trials Centre at St Vincent's Hospital in Sydney. The final report is expected to be completed by October.

Perthoxal -- whose name is based on Bone's home town of Perth, in WA -- contains teriparatide, a recombinant form of the 34 amino-terminal amino acids of human parathyroid hormone, which stimulates bone formation.

The primary aim of the study was to assess the safety and tolerability of Perthoxal oral PTH in two different formulations. A secondary aim was to determine whether Perthoxal oral PTH has the desired result of increasing the concentration of calcium in the bloodstream and the levels of PTH in the blood.

Each participant received a placebo and two of the possible three PTH forms -- two Perthoxal test formulations and Eli Lilly's Forteo, an injectable dosage form of PTH as a positive control.

"The only differences with our formulation, was the coating on the capsule to work on release characteristics through the gut," said Bone Medical COO John Fitzgerald.

Forteo was approved by the USE FDA in November 2002 for the treatment of osteoporosis and also contains teriparatide.

"Forteo is only an injectable. So fundamentally the only difference is the route of administration," said Fitzgerald. "And obviously if you bring out an oral form, that's just miles ahead in terms of its acceptability to the patient."

For each subject, blood samples were taken over a 10-hour post-treatment period for the subsequent measurement of calcium, PTH and a biological marker of bone turnover.

"One of the beauties for bone, with both our two products -- the other one we have is Capsitonin -- is the drugs themselves are known, they're already approved so we don't have to go through the same rigour in terms of the early Phase I," said Fitzgerald.

Once the trial results are complete, Perthoxal will undergo a dose ranging study of some form, hopefully a Phase II trial, said Fitzgerald.