Psiron's Cavatak recevies FDA orphan drug designation

By Ruth Beran
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.

Related News

Lipid science receives new Australia-led online hub

The Lipid Network launched this month to build links between researchers, clinicians and industry...

Proposed Australian trial eyes up blood testing for Alzheimer's

Utilising networks of GPs across three states, a large-scale study intends on combining digital...

Applications open for $300K pandemic therapeutics fellowships

Applications are now open for the Cumming Global Centre for Pandemic Therapeutics' inaugural...


  • All content Copyright © 2026 Westwick-Farrow Pty Ltd