TransPharma Announces Successful Results of a Phase I Clinical Trial for Musculoskeletal Disorders
TransPharma Medical Ltd., a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing a proprietary active transdermal drug delivery technology, recently announced 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.
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 post-menopausal women treated with four different transdermal Calcitonin doses (60 to 300 mcg) compared to 100 IU 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 post-menopausal 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.
TransPharma’s ViaDerm drug delivery system incorporates a hand-held electronic device, which creates microscopic passageways through the outer layer of the skin, allowing for transdermal delivery of a wide variety of drugs from a patch. The system provides a cost-effective, easy-to-use, virtually pain-free, self-administered solution that enables the safe, reproducible, and accurate delivery of a broad range of product candidates, including hydrophilic small molecule, such as peptides and proteins.
Established in 2000, TransPharma Medical Ltd. is a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing its proprietary active transdermal drug delivery technology. The company aims to develop multiple drug products through strategic partnerships with leading pharmaceutical companies and through independent product development. TransPharma currently has three drug products in clinical trials: ViaDerm-hPTH (1-34) product for the treatment of osteoporosis developed in collaboration with Eli Lilly and currently in Phase IIb clinical studies; ViaDerm-GLP1 agonist for the treatment of type II diabetes that has completed Phase Ib clinical study; and the ViaDerm-Calcitonin which has completed a Phase I clinical trial.
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