Ruggell, Liechtenstein, 24 February 2010, Pantec Biosolutions AG, a privately-owned company developing innovative transdermal drug delivery products, announced today that it has achieved excellent results in a Phase I clinical trial of a FSH (follicle stimulating hormone) patch used in conjunction with the company’s novel P.L.E.A.S.E.^® (Painless Laser Epidermal System) technology. 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.

“This FSH patch Phase I trial represents a key milestone achieving proof-of-concept and demonstrating for the first time that P.L.E.A.S.E.^® enables delivery of large proteins such as FSH efficiently in therapeutic amounts from a stable patch,” said Christof Boehler, CEO of Pantec Biosolutions. “This validation of P.L.E.A.S.E.^® is an extremely important milestone that moves the company forward and significantly closer to commercialisation."
 
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.

As a consequence of these excellent results, Pantec Biosolutions is now planning a future Phase II study with the new P.L.E.A.S.E.^®-FSH patch.


About Pantec Biosolutions and P.L.E.A.S.E.^®
Pantec Biosolutions AG is a private drug delivery company specialised in using laser microporation technology to deliver large molecular weight drugs into the epidermis for local or systemic uptake. Its proprietary P.L.E.A.S.E.^® (Painless Laser Epidermal System) platform enables efficient, needle-free and painless administration of biopharmaceutical drugs, in varying and individualised dosages, through partnered patch technology. The technology is currently in clinical trials for the delivery of IVF hormone therapy, a market with an estimated value of US$1.5 – 2 billion.

Pantec Biosolutions’ P.L.E.A.S.E.^® platform is available both for the development of the Company’s own pipeline and for penetration into new markets through strategic partnerships. Pantec Biosolutions is based in Ruggell, Liechtenstein.

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About FSH

Follicle-stimulating hormone (FSH) is a hormone found in humans and other animals. It is synthesized and secreted by gonadotropes of the anterior pituitary gland. FSH regulates the development, growth, pubertal maturation, and reproductive processes of the body. FSH and Luteinizing hormone (LH) act synergistically in reproduction. FSH stimulates the growth and recruitment of immature Ovarian follicles in the ovary.