TransPharma Announces Successful Results of a Phase 1 Clinical Trial of ViaDerm-Calcitonin for the Treatment of Musculoskeletal Disorders

- Primary and Secondary Endpoints Were Met –

LOD, Israel--(BUSINESS WIRE)--Jan 11, 2011 - 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.

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.”

About the Self Applied ViaDerm Drug Delivery System

TransPharma's ViaDerm drug delivery system incorporates a handheld 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.

About Osteoarthritis

Osteoarthritis is a degenerative joint disease involving gradual degradation of joints. Symptoms may include joint pain, tenderness, stiffness, locking of the joint and swelling. When bone surfaces become less well protected by the loss of cartilage, the bone may be damaged, leading to the various Osteoarthritis symptoms, and a decreased quality of life. In severe cases the joint might need replacement surgery. Osteoarthritis is the leading cause of chronic disability, affecting nearly 27 million people and totaling $60 billion annually in related healthcare costs in the U.S. alone.

About Musculoskeletal Pain

Non-malignant musculoskeletal pain is the most common clinical symptom that causes patients to seek medical attention and is the major cause of disability in the world. Musculoskeletal pain can arise from a variety of common conditions including osteoarthritis, rheumatoid arthritis, osteoporosis, surgery, low back pain, and bone fracture. The musculoskeletal market is the sixth largest therapeutic category by sales.

About TransPharma Medical

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 3 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 2b clinical studies; ViaDerm-GLP1 agonist for the treatment of type II diabetes that has completed phase 1b clinical study; and the ViaDerm-Calcitonin which has completed a Phase 1 clinical trial. For more information, please visit the Company's website at www.transpharma-medical.com.

Contact: TransPharma Medical Ltd.
Tsipi Haitovsky
Media Liaison
+972-52-598-9892
tsipih@netvision.net.il

 

Posted: January 2011

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