26-Feb-2010 - College Hill

Pantec Biosolutions reports successful Phase I for delivery of FSH

First time a protein this large has ever been successfully delivered transdermally

Pantec Biosolutions AG announced 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 protein as large as 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.AS.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."

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.

Facts, background information, dossiers
More about Pantec Biosolutions
  • News

    Pantec Biosolutions Closes CHF 20 Million Financing

    Pantec Biosolutions AG announced the closing of a CHF 20 million investment achieved by two financing rounds. The StemCell Holding AG, an Austrian investment company in the life sciences sector, acted as lead investor. No further terms were disclosed. The investment strengthens Pantec’s fi ... more

    Pantec Biosolutions Granted European Patent for P.L.E.A.S.E

    Pantec Biosolutions AG announced that it has been granted European Patent No. EP1874213, entitled ‘LASER MICROPORATOR’ by the European Patent Office. The patent, which was granted in September, covers the technology used in the company’s lead product P.L.E.A.S.E.® (Painless Laser Epidermal ... more

    Pantec Biosolutions receives ISO 13485 certification

    Pantec Biosolutions AG announced that it has successfully established a Quality Management System (QMS) in accordance with ISO 13485:2003 standards for medical devices. In order to achieve ISO standards, Pantec Biosolutions implemented a QMS for its operations to ensure consistent quality o ... more