Human growth hormone, hGH, (also known as somatropin) is a protein secreted by the pituitary gland that is critical to normal growth in children and is involved in regulating metabolism in both children and adults. Growth hormone is normally secreted throughout a person’s lifetime. The need for hGH drug products is a significant one, as many clinical conditions necessitate treatment with hGH.

It is estimated that approximately 70,000 adults and 40,000 children are affected by growth hormone deficiencies worldwide. The incidence of growth hormone deficiencies is estimated at 3 in every 10,000 adults and 1 in every 3,500 children. In addition to these types of growth hormone deficiency disorders, hGH treatment can also be effective in other disease conditions, thereby potentially expanding the market size. The worldwide market for hGH is currently estimated at around $2B with an annual growth rate of 15%.

Five Phase I/1b studies testing the safety of the ViaDerm-hGH product with both single administration and repeated applications were conducted in order to optimize the ViaDerm device parameters for transdermal delivery of hGH and the hGH transdermal dose targeted to reach pharmacokinetic (PK) profiles similar to that of SC Tev-tropin®; and to determine the PK profile, relative bioavailability and optimal hGH dose of transdermal hGH as compared to SC Tev-tropin®.

Transdermal hGH was delivered using TransPharma’s fully integrated ViaDerm system, which is comprised of a proprietary device and a 5cm2 dry hGH patch which maintained very good long-term stability.

TransPharma has successfully completed four Phase I human clinical trials on transdermal hGH in which safety, tolerability and PK profiles were clearly demonstrated. These studies also resulted in finding the optimal system parameters that yielded a PK profile similar to SC with a high relative bioavailability of up to 36% in comparison to SC and good correlation between patch dose and serum levels.

The parameters found in these Phase I studies were implemented in the subsequent Phase Ib ascending three dose parallel, double-blind cross-over study. This study evaluated safety and tolerability in response to 22 day repeat ViaDerm-hGH applications and compared the PK and pharmacodynamic (PD) profiles of three ascending doses of ViaDerm-hGH to SC hGH injections. The study included 53 adult hGH deficient subjects in three treatment groups.

Results of this study showed very good safety and tolerability profiles. The PK profile for transdermal delivery was similar to that of SC injection. PK results demonstrated transdermal delivery of active hGH during the entire 22 day administration period. The systemic exposure of hGH and IGF-1 levels generally increased with patch dose elevation. IGF-1 levels were similar on day 7 and 22.

The Phase Ib clinical trial met its main end points. Transdermal hGH and the use of the ViaDerm system were shown to be safe, well-tolerated and effective.

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