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SaturdayNovember 5SESSION TWO10:55 – 11:15Click here to return to Dermatology Update 2005 Schedule and Abstracts
Click here to download this abstract as an Adobe Acrobat PDF file |
Karin J. HambergVitamin D, also known as 1α, 25(OH)2D3, possess many interesting characteristics in addition to the classical calcium regulating effects. These include potent anti-proliferative effects on several cell lines, including keratinocytes. During the 1980’s, LEO Pharma synthesized more than 1100 Vitamin D analogues with the intent of separating the anti-proliferative effect from the calcaemic effect, thereby increasing the therapeutic window. Originally, the compounds were aimed for systemic treatment of cancer, but the lead compound, calcipotriol, proved more suitable for topical use in psoriasis. The presentation reviews the development history of calcipotriol from the first synthesis in 1985 through approval of the Dovonex® product range to the recent approval of the combination product Dovobet® ointment in Canada in 2002. The clinical development of the Dovonex® and Dovobet® product range has included >50 clinical trials investigating the efficacy and safety of Dovonex® ointment, Dovonex® cream, Dovonex® scalp solution and 8 potential follow-up compounds, none of which proved better than calcipotriol. With significant help from Canadian patients and investigators, the benefits of the Dovonex® and Dovobet® portfolios have been extensively documented both as single drug treatments and in combination with several other treatments of psoriasis. Recently, LEO has submitted an NDA with the aim of obtaining a marketing authorization for Dovobet® ointment in the US. The presentation reviews the extensive pre-clinical and clinical programme on which this application is based. Further, the presentation reviews a list of interesting calcipotriol-based products presently in development for psoriasis and other indications. These include new treatments for scalp psoriasis, facial psoriasis, psoriasis on thin skin areas, and different types of eczema. Click here to return to Dermatology Update 2005 Schedule and Abstracts |