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

Oxytocin analogue treats chronic abdominal pain

Researchers have developed a new class of oral painkillers to suppress chronic abdominal pain,...

'Low-risk' antibiotic linked to rise of dangerous superbug

A new study has challenged the long-held belief that rifaximin — commonly prescribed to...

Robotic hand helps cultivate baby corals for reef restoration

The soft robotic hand could revolutionise the delicate, labour-intensive process of cultivating...


  • All content Copyright © 2024 Westwick-Farrow Pty Ltd