Psiron's Cavatak recevies FDA orphan drug designation
Wednesday, 21 December, 2005
Sydney oncology therapy developer Psiron (ASX:PSX) has received orphan drug designation from the US Food and Drug Administration (FDA) for its lead oncolytic virus Cavatak (coxsackievirus A21) for the treatment of stage II, stage III and stage IV melanoma.
Currently in phase I studies, Psiron is hoping that Cavatak will be on the market within three to five years, with orphan drug status compressing the clinical development timeframe, as well as giving seven years market protection against generic products, a reduction in clinical data required for product registration, tax incentives and reduced filing fees.
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