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 successful results of a Phase I clinical trial of its self-applied ViaDerm-Calcitonin product for the treatment of musculoskeletal disorders such as osteoarthritis and musculoskeletal pain.
“It leads us to believe that enhancing these capabilities with the ease of use, virtual painlessness, small size and portability of our ViaDerm system may open up a myriad of possibilities to expand the therapeutic applications of Calcitonin beyond the current approved indications.”
The Phase I study was an open label single dose cross-over trial to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of ViaDerm-Calcitonin in 12 postmenopausal women treated with 4 different transdermal Calcitonin doses (60-300 mcg) compared to 100IU of Miacalcin, the subcutaneous injected form of the Calcitonin.
Study results demonstrated a clear PK dose response corresponding to the escalating doses of the ViaDerm-Calcitonin patches. Furthermore, a single administration of ViaDerm-Calcitonin resulted in a statistically significant reduction of bone resorption and cartilage degradation biomarkers, CTX-I and CTX-II, similar to the reduction obtained with daily injections of 100 IU Miacalcin. All doses of ViaDerm-Calcitonin were safe and well-tolerated and demonstrated a favorable profile with regard to skin safety.
Calcitonin is commercially available in subcutaneous, intramuscular and nasal routes for the treatment of postmenopausal osteoporosis, hypercalcemia, and Paget's disease. Calcitonin is a very safe drug that has been widely used for many years and is currently being assayed for the treatment of osteoarthritis and various musculoskeletal clinical painful conditions.
"We are very pleased with the results of this study, which demonstrate that our transdermal Calcitonin is safe and as efficacious as a subcutaneous injection," said Dr. Daphna Heffetz, CEO of TransPharma Medical. "It leads us to believe that enhancing these capabilities with the ease of use, virtual painlessness, small size and portability of our ViaDerm system may open up a myriad of possibilities to expand the therapeutic applications of Calcitonin beyond the current approved indications."
SOURCE TransPharma Medical