Clinical-stage precision medicine company EXACT Therapeutics AS (Euronext Growth Oslo:EXTX) announced on Monday that it has received clearance from the US Food and Drug Administration (FDA) to initiate its Phase 2 ENACT trial.

This single-arm study will evaluate the safety and efficacy of Acoustic Cluster Therapy (ACT) in combination with modified FOLFIRINOX in the first-line treatment of patients with locally advanced or borderline resectable pancreatic cancer. The company anticipates an initial safety review in mid-2025.

The new clinical trial builds on the positive results from the Phase 1 ACTIVATE trial in patients with liver metastases, and the FDA clearance further underscores the potential of ACT as a promising treatment modality for cancer patients.