Ruggell, Liechtenstein, 20 April 2009- 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 triptorelin patch used in conjunction with the company’s novel P.L.E.A.S.E.® (Painless Laser Epidermal System) technology.
The purpose of the study was to investigate the safety and tolerability of the newly developed triptorelin patch as well as the primary pharmacokinetic characteristics in healthy male volunteers. Due to its size and physicochemical properties, triptorelin 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 created microchannels in the skin’s outermost layer, the stratum corneum, and facilitated triptorelin administration; accelerating release from the patch and uptake into the dermis, where the molecule entered the systemic circulation.
All of the volunteers considered the method to be convenient and simple and there were no reports of any adverse events.
Results showed that serum levels of triptorelin exceeded those required for therapeutic effect. Triptorelin is administered daily by subcutaneous injection in the induction phase of in vitro fertilisation protocol. Triptorelin is also used to treat prostate cancer, endometriosis and precocious puberty. The serum profiles further demonstrated that the P.L.E.AS.E.® – triptorelin patch combination was able to achieve reproducible pharmacokinetics with little inter-individual variability.
“This pilot study shows that our novel technology is an effective and safe method for the transdermal delivery of triptorelin, which is currently administered only by injection. This validation of P.L.E.A.S.E.® is an extremely important milestone that puts the company on a different level with respect to partnering opportunities." said Christof Boehler, CEO of Pantec Biosolutions.
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.
Triptorelin is a synthetic decapeptide agonist analogue of gonadotropin-releasing hormone (GnRH), and is used for the suppression of gonadal sex hormone production in the treatment of malignant neoplasms of the prostate, deviant sexual behavior in men and precocious puberty. In women, triptorelin is given to manage endometriosis, uterine fibroids and as a daily subcutaneous injection over a period of up to one month to treat female infertility.