PhotoCure gets OK for Hexvix trials in USA
Norway's PhotoCure has been granted approval to begin a Phase III trialof Hexvix, its photodiagnostic product for the detection of bladder cancer using fluorescence cytoscopy, in the USA. The study, which will start shortly, will compare Hexvix with standard white light cytoscopy at centers across Europe and the USA.
Hexvix is PhotoCure's second pharmaceutical product after Metvix (amino laevulinic acid), its photodynamic therapy for actinic keratosis and basal cell carcinoma, which has just been approved in Europe (Marketletter December 10). The company hopes to file for approval of Hexvix during the first half of 2003, and says the potential commercial rewards are promising, given that there are 2.5 million cytoscopies carried out each year in the USA and Europe in order to diagnose or rule out bladder cancer.
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