Bone completes first stage of osteoporosis drug trial

Bone Medical (ASX:BNE) has reported that its oral parathyroid hormone (PTH) product Perthoxal, for the treatment of osteoporosis, proved safe and tolerable in a phase I trial.

The trial, which involved 18 post-menopausal women, was conducted at the Clinical Trials Centre at St Vincent's Hospital in Sydney.

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

"The main purpose of the study was to prove safety and tolerability of Perthoxal oral PTH in two different formulations -- and that's what we did," said Bone executive chairman Paul Hopper. "

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 which was approved by the US FDA in November 2002 for the treatment of osteoporosis.

"The compound remains the same -- it is a different delivery system, not a new drug," said Hopper. "A capsule version is needed and [would be] far more comfortable for sufferers of osteoporosis." Following the results, Bone began to recruit for a small formulation trial of about 10-12 patients in Brazil. "Brazil was chosen by Bone chief scientific officer Dr Roger New due to cost factors and the reputation of the centre in San Paolo," Hopper said. "After this is completed we will commence a toxicology study at the same time as the dose range study, which will take place in Queensland."

Bone met with the FDA for a pre-IND meeting late last year to discuss its lead program, an oral version of osteoporosis drug salmon calcitonin, named Capsitonin. Plans are underway to submit the IND application later this year.

Last year saw many changes to the Bone management team. Michael Redman, for example, was in the CEO role for just seven months. "The company's management is secure," said Hopper. "The chemistry in boards must be good and with the addition of Pat Mallon we are a more solid team than ever before. We run on the smell of a rag and have very few overheads."