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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, July 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® 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 cm2 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®
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 among 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.
About Osteoporosis
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 proprietary 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.
Company Contact:
Naomi Rabbie
Marketing Manager
+972-8-915-2201 x251
naomir@transpharma.co.il
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