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news.Pantec Biosolutions has achieved positive results in a Phase I clinical trial of a FSH (follicle stimulating hormone) patch used in conjunction with the company’s novel PLEASE (Painless Laser Epidermal System) technology.
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Pantec said that 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’ PLEASE 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 PLEASE – 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.
Currently, FSH is self-administered by the patients for 10-12 days by daily subcutaneous or intramuscular injection stimulating follicle growth during an In-Vitro Fertilisation (IVF) protocol. FSH is used in all major IVF procedures. The patch will avoid these multiple injections improving ease of use and convenience.
The company is now planning a future Phase II study with the new PLEASE-FSH patch.
Christof Boehler, CEO of Pantec Biosolutions, said: “This FSH patch Phase I trial represents a key milestone achieving proof-of-concept and demonstrating for the first time that PLEASE enables delivery of large proteins such as FSH efficiently in therapeutic amounts from a stable patch. This validation of PLEASE is an extremely important milestone that moves the company forward and significantly closer to commercialisation.”