A seven day, repeated dose application, parallel group study was conducted on 48 healthy, elderly, post-menopausal women. The study was designed to evaluate the safety and tolerability of ascending multiple doses of hPTH (1-34) patches and to compare the pharmacokinetic profiles of the transdermally delivered doses of hPTH (1-34) with that of FORTEO(R) administered subcutaneously.
Transdermal hPTH (1-34) was delivered using TransPharma's fully integrated product, which is comprised of a proprietary pocket-sized device and 1 cm(2) dry hPTH (1-34) patch with demonstrated room-temperature stability.
Once-daily transdermal delivery of all doses tested in this trial demonstrated a safety profile similar to the one observed in the FORTEO(R) subcutaneous injection. All safety parameters (including calcium and phosphorous) of the different transdermal doses were within the normal range. Furthermore, all ViaDerm-hPTH (1-34) doses were very well tolerated by participants.
Pharmacokinetic profiles of hPTH (1-34) in the first and seventh day were similar, showing no accumulation of hPTH (1-34) levels and no deterioration in hPTH (1-34) systemic levels. These findings demonstrate the ViaDerm-hPTH (1-34) product's ability to provide reproducible drug levels resulting in excellent inter- and intra-participant variability.
Transdermally delivered hPTH (1-34) of all doses showed desirable peak profiles with relative bioavailability of approximately 40%. This bioavailability is amo ng the highest reported bioavailability of alternative drug delivery routes to subcutaneous administration.
"We are very excited by the results of our phase I studies. The promising findings are further validation that the ViaDerm-hPTH (1-34) product can provide a viable alternative administration route for hPTH (1-34) for women suffering from osteoporosis, which would alleviate the pain and inconvenience associated with their current treatment, thereby increasing compliance," said Dr. Daphna Heffetz, CEO of TransPharma Medical Ltd. "Strongly encouraged by the results of our series of phase I studies, which included a total of 66 post-menopausal healthy women volunteers, we plan to initiate a phase II study of the ViaDerm-hPTH (1-34) product, bringing this potential product to an advanced clinical stage before seeking a partner to take it to market," Dr. Heffetz added.
hPTH (1-34) is currently the only osteoporosis drug to possess anabolic properties. According to the National Osteoporosis Foundation, approximately 10 million people in the US currently suffer from osteoporosis and another 34 million are estimated to have low bone mass, placing them at increased risk for the disease. Over the next five years, the number of people suffering from osteoporosis is expected to reach 52 million, creating a $10.4 billion market by 2011.
About the ViaDerm System
TransPharma's ViaDerm drug delivery system incorporates a handheld electronic control unit combined with a drug patch. The system provides a cost-effective, easy-to-use, self-administered solution that enables the safe, reproducible and accurate delivery of a wide variety of product candidates, including hydrophilic small molecules, peptides and proteins.
About TransPharma Medical
Established in 2000, TransPharma Medical Ltd. is a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing a proprietar y active transdermal drug delivery technology. TransPharma aims to develop multiple drug products through strategic partnerships with leading pharmaceutical companies and through independent product development. For more information, visit the Company's website at www.transpharma-medical.com.
TransPharma Medical Ltd.
Naomi Rabbie, +972-8-915-2201 ext. 251