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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, January 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.
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