Antisense Pharma obtains IND for clinical studies of trabedersen in the USA

German biopharmaceutical company Antisense Pharma says that the US Food and Drug Administration has issued an Investigational New Drug-authorization for clinical studies with its trabedersen for patients with high-grade glioma. This entitles the company to include US-American clinics both in the Phase III study SAPPHIRE and in further studies.

The aim of the international, randomized, active-controlled approval study is to confirm the promising results obtained in previous studies concerning the efficaciousness and safety of the Antisense active ingredient trabedersen on 132 adult patients with recurrent, or refractory high-grade anaplastic astrocytoma (malignant brain tumor, WHO Grade III).

Phase III-Study SAPPHIRE goes to the USA