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TransPharma Medical Announces Positive Results of Phase I Clinical,Trials for Transdermal Delivery of hPTH (1-34) for Osteoporosis,Treatment

LOD, Israel--(BUSINESS WIRE)--Jul 9, 2007 - TransPharma Medical Ltd., a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing a proprietary active transdermal drug delivery technology, announced today promising results of its phase I clinical trials demonstrating the safety and pharmacokinetic profile of its ViaDerm-hPTH (1-34) product for the treatment of osteoporosis.

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
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