Pantec Biosolutions of Liechtenstein just announced positive results from a Phase I clinical trial of the FSH (follicle stimulating hormone) patch when used in conjunction with the firm’s proprietary P.L.E.A.S.E. microporation drug delivery device. The system, profiled by us before, uses painless lasers to create cutaneous micropores prior to transdermal injection of large molecular weight drugs. The P.L.E.A.S.E. system is designed to be flexible in the number of the micropores and the depth of delivery, allowing to fine-tune the amount of a therapeutic injectate.
From the latest announcement:
Although smaller peptides and some proteins have previously been delivered transdermally, this is the first time a molecule as large as this protein (32 KDa) has been successfully delivered in this way.
The purpose of the study was to investigate the primary pharmacokinetic characteristics as well as the safety and tolerability of the newly developed FSH protein patch in healthy male volunteers. Due to its size and physicochemical properties FSH, a 32 KDa protein hormone, cannot permeate passively across intact skin. Therefore, prior to patch application, the skin was microporated using Pantec Biosolutions’ P.L.E.A.S.E.® laser device. This pre-treatment creates microchannels in the skin’s outermost layer, the stratum corneum, that facilitate FSH transport through the skin and accelerate its entry into the systemic circulation.
The serum profiles further demonstrated that the P.L.E.A.S.E.® – FSH patch combination was able to achieve reproducible pharmacokinetics with negligible inter-individual variability. All of the volunteers considered the method to be convenient and easy to use, and there were no reports of any adverse events.
Product page: The P.L.E.A.S.E. – platform …
Animation showing the functionality of the P.L.E.A.S.E. system…
Press release: Pantec Biosolutions reports successful Phase I for delivery of FSH using P.L.E.A.S.E. …
Flashbacks: P.L.E.A.S.E. = Painless Laser Epidermal System ; P.L.E.A.S.E. To Improve Effectiveness of Drug Patches