Policy & Regulation
Viracta Therapeutics' IND application for Phase 1b/2 Trial in Epstein-Barr Virus-Positive (EBV+) Solid Tumours receives US FDA approval
22 July 2021 -

Viracta Therapeutics Inc (Nasdaq: VIRX), a US-based precision oncology company targeting virus-associated malignancies, announced on Wednesday that it has received approval from the United States Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to proceed into a Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) and other EBV+ solid tumours.

The global Phase 1b/2 trial is aimed at assessing the safety and preliminary efficacy of Viracta's all-oral combination regimen in advanced EBV+ solid tumours (including EBV+ RM-NPC), and in combination with the PD-1 inhibitor pembrolizumab in EBV+ RM-NPC.

The trial is likely to start in the second half of 2021.

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