Transpharma Medical announces promising results in the first phase of their clinical trial in the development of a transdermal delivery product of hPTH (1-34) intended for the treatment of osteoporosis
The bio-pharmaceutical company Transpharma Medical, which specializes in the development and commercialization of medical products based on a unique technology of transferring drugs through the skin, today announced promising results in the first phase (Phase I of the clinical trials that demonstrate the safety of the ViaDerm-hPTH product (1-34 ) for the treatment of osteoporosis and show the profile of the drug in the blood compared to treatment with FORTEO, the drug currently given by subcutaneous injection.
The clinical study was conducted over seven days and included repeated administration of the drug to 48 healthy elderly women who had gone through menopause. The aim of the study was to evaluate the safety of increasing doses of hPTH (1-34) in patches. Another objective was to compare the transdermal profile of hPTH (1-34) in the blood with that obtained as a result of the administration of FORTEO by subcutaneous injection.
The transfer of hPTH (1-34) through the skin was done with the help of an integrated Transpharma product that includes a device the size of a palm and a patch the size of one square centimeter that contains the medicinal substance hPTH (1-34) and has been proven to be stable even at room temperature.
Daily transdermal administration of hPTH (1-34) of all doses tested in this trial showed a safety profile similar to that observed with subcutaneous injection of FORTEO. All the safety parameters (including the level of calcium and phosphorus in the blood) measured after administering various doses of the drug through the skin were within the normal range.
The profile of hPTH (1-34) in the blood on the first day and on the seventh day of the experiment was similar. This phenomenon indicates that there was no accumulation or decrease in hPTH (1-34) levels in the bloodstream. These findings indicate the ability of the ViaDerm-hPTH (1-34) product to provide equal levels of the drug with low variability between the different treatment days and between patients.
All doses of hPTH (1-34) delivered through the skin showed a desirable profile with an absorption level of about 40% compared to the administration of FORTEO by subcutaneous injection. This level of absorption is among the highest published among alternative delivery methods for injecting drugs.
"We are very excited about the results of the first phase of our clinical trial. These promising findings provide further evidence that our ViaDerm-hPTH (1-34) product can offer an alternative way of delivering hPTH (1-34) to women suffering from osteoporosis. Administering the drug through the skin can alleviate the pain and discomfort of the existing treatment and thus increase compliance with the treatment," said Dr. Dafna Hefetz, CEO of Transpharma Medical. "Encouraged by the results of the Phase 1 trial series, which included 66 healthy menopausal volunteers, we plan to begin the second phase of the trials with the ViaDerm-hPTH (1-34) product, and take the product to an advanced clinical stage before looking for a partner suitable to release it to the market," added Dr. Hefetz.
About osteoporosis
hPTH (1-34) is today the only drug for osteoporosis that has bone building capabilities. According to the National Osteoporosis Organization in the US, approximately 10 million people suffer from osteoporosis in the US and another 34 million suffer from low bone density that puts them at risk of developing the disease. Over the next five years, the number of people suffering from osteoporosis could reach 52 million, creating a market size of $10.4 billion by 2011.
About the ViaDerm system
The ViaDerm system for delivering drugs through the skin consists of a palm-sized device that operates using batteries and a patch that contains the drug. The system provides a solution for self-administration of drugs in a cost-effective and simple way to operate and enables the transfer through the skin of a wide variety of medicinal substances, including small water-soluble molecules, peptides and proteins, in a safe and precise manner.
About Transpharma Medical
Transpharma Medical Ltd., which was established in 2000, is a biopharmaceutical company specializing in the development and marketing of medical products based on a unique technology of delivering drugs through the skin. Transpharma aims to develop many medicinal products through strategic collaborations with biopharmaceutical companies as well as through independent product development.
For more details, you can visit the company's website.
