TransPharma Medicalâ„¢ Ltd, of Lod, Israel, announced promising results from the first human clinical trials demonstrating transdermal delivery of human parathyroid hormone 1-34 fragment (hPTH 1-34) for the treatment of osteoporosis. The results of the study, presented at IIR's Drug Delivery Partnerships 2006 conference held in London, England, demonstrate systemic delivery of therapeutic dosages of bioactive hPTH (1-34). These results show an ability to deliver the required hPTH (1-34) dose via TransPharma's pen-sized system using a 1-cm2 small patch.
The patch utilized in the study is TransPharma's proprietary dry protein patch, developed for the company's ViaDermâ„¢ transdermal drug delivery system. TransPharma formulated hPTH (1-34) into a stable, printed, dry-form patch that allows the drug to be delivered into the patient's systemic circulation. Analysis of two biomarkers (ionized calcium and phosphorus) confirmed that the bioactivity of the delivered hormone was maintained.
The ViaDerm delivery system incorporates the RF-MicroChannels device, which creates microscopic passageways through the outer layer of the skin. This system allows for the therapeutic administration. via patch, of a wide variety of drugs. This device is a handheld, pen-sized unit, which provides for a painless, very low-cost, easy-to-use application.
The hPTH (1-34), which is the only anabolic osteoporosis drug molecule, is currently being administered by injection only and is expected to reach $3 billion in sales by 2010.
— A. Techman