August 2010. The biopharmaceutical company Antisense Pharma announced today that the US-American Food and
Drug Administration (FDA) has issued an Investigational New Drug (IND)-authorisation for clinical studies with trabedersen for patients
with high-grade glioma.
This authorisation entitles the company to include US-American clinics both in the phase III study SAPPHIRE
and in further studies. Within the IND-authorisation, the FDA also agreed that trabedersen may be administered with an innovative application
system, developed by Antisense Pharma, via CED (Convection Enhanced Delivery).
Further information is available here.
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