EXACT Therapeutics announced positive final data from its Phase 1 ACTIVATE trial, demonstrating that Acoustic Cluster Therapy (ACT) significantly improves chemotherapy’s effectiveness in patients with colorectal liver metastases. The trial showed increased tumor shrinkage in patients receiving ACT combined with chemotherapy compared to chemotherapy alone. This success validates ACT’s clinical potential and supports the upcoming Phase 2 ENACT trial in pancreatic cancer.
This positive data is a critical step forward in addressing the unmet need for more effective treatments for difficult-to-treat cancers like pancreatic cancer and metastatic colorectal cancer. The significant improvement in tumor response suggests that ACT could potentially extend survival and improve quality of life for patients facing these aggressive diseases. The confirmation of a dose-response relationship provides valuable information for optimizing treatment protocols in future studies. Moreover, the positive safety profile reinforces the potential for broader clinical application.
The ACTIVATE trial results showed a 29% reduction in tumor diameter for patients receiving ACT with chemotherapy compared to a 7% reduction with chemotherapy alone in responding patients. The higher PS101 dose (40 µl/kg) also demonstrated greater tumor shrinkage than the lower dose (20 µl/kg), indicating a dose-response relationship. Importantly, the treatment was found to be safe and well-tolerated when combined with chemotherapy. The study involved 11 hard-to-treat patients, with 9 evaluable, and utilized a within-patient control design to compare ACT-treated and non-treated lesions.
These results position EXACT Therapeutics for continued progress in its clinical development program. The positive Phase 1 data strongly supports the initiation of the Phase 2 ENACT trial, which will focus on locally advanced or borderline resectable pancreatic cancer—a disease with a notoriously poor prognosis and limited treatment options. The findings also pave the way for further exploration of ACT’s potential in other cancer types, expanding the therapeutic reach of this promising technology.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
