History and Timelines2009 – Clinical proof of concept for infertility
• Successful clinical proof of concept with triptorelin (peptide hormone for downregulation in infertility treatment). P.L.E.A.S.E. works with peptides and proteins. • Very promising clinical data with FSH (protein 32 KDa, for egg cell maturisation) • Animal study in collaboration with recombinant allergen company underway to test active epidermal immunisation principle with P.L.E.A.S.E. avoiding multiple injections.
2008 - P.L.E.A.S.E.® -device CE marked
• First hand-held lasers produced CE-mark received • ISO 13485 certification achieved, device production facilities established • Virtual pharma firm established with a preclinical centre in Geneva, patch and clinical development in Germany and API suppliers in Europe. Pantec BS is GDP (Good Distribution Practises) certified. • Collaboration agreement with Pharma company in place
2007 - P.L.E.A.S.E.® (Painless Laser Epidermal System) -platform developed
• Most efficient 3 micron laser system of its size developed by PBS team • Six drugs tested in vitro. They all permeate in clinically relevant concentrations
2006 - Human clinical cutaneous tolerability study concluded positively
• The study conducted with 12 volunteers resulted in discrete pores with little or no discomfort for the patients and no thermal damages of the pore adjacent skin layers. • The way for human IVF hormone bioavailability studies is now open
2005 - The founding of Pantec Biosolutions AG
• Founding of Pantec Biosolutions AG with the mission to develop and commercialise an intraepidermal solution consisting of a device for the pre-treatment of human skin and novel drug patches that are applied after pre-treatment with the goal to deliver IVF hormones and other large molecules intraepidermally.
2005 - The feasibility study
• Development and construction of a test device for the laser pretreatment of human skin together with Pantec Engineering AG (www.pantec.com), Pantec Biosolutions' sister company. • In vitro human skin permeation studies with two IVF hormones after pretreatment resulted in very high drug flux versus very low permeation without pretreatment.
2004 - The business idea
• The internationally known specialist in In Vitro Fertilisation (IVF) Prof. Dr. Herbert Zech (Institutes for Reproductive Medicine and Endocrinology, Bregenz Austria, www.ivf.at) identified a strong demand among his patients to replace daily painful hormone injections needed in artificial reproduction. • A transdermal route was suggested because it is a proven drug delivery method, when long lasting constant systemic hormone concentrations are needed, as is the case in IVF. • IVF hormones are either large proteins or water insoluble steroid hormones. Both categories penetrate the skin either not at all or only in very low amounts, which makes the use of a conventional passive intraepidermal patch impossible. Consequently a new active intraepidermal method to pretreat the skin prior to hormone patch application had to be developed. • The method had to be safe, painless and simple to use by the patients at home. All these features will be realised in a hand-held medical device. |