EXACT Therapeutics announces positive final results in Phase 1 ACTIVATE trial in liver metastases from colorectal cancer

Core Insights - EXACT Therapeutics announced positive final data from its Phase 1 ACTIVATE trial, demonstrating the efficacy of its Acoustic Cluster Therapy (ACT) combined with chemotherapy for patients with liver metastases of colorectal origin [1][3][8] - The results support the initiation of the ENACT Phase 2 study in pancreatic cancer, addressing a significant unmet medical need [1][8] Group 1: Trial Results - The ACTIVATE trial showed that tumor shrinkage was significantly greater with ACT and chemotherapy compared to chemotherapy alone, with a reduction of -29% versus -7% among responding patients (p<0.05) [3][8] - A clear dose-response relationship was observed with the proprietary agent PS101, where 3 out of 4 patients receiving 40 µl/kg PS101 showed tumor shrinkage of more than 30% in diameter [4][8] - The trial enrolled 11 patients, with 9 being evaluable, and was conducted at sites in the United Kingdom [9] Group 2: Safety and Efficacy - PS101 was found to be safe and well-tolerated when administered with chemotherapy, mirroring the excellent safety profile seen in interim results [4][8] - The trial's design allowed each patient to serve as their own control, enhancing the reliability of the anti-tumor activity assessment [7] Group 3: Future Plans - The company plans to present detailed data from the ACTIVATE trial at a future scientific publication and medical conference [5] - The CEO expressed excitement about the upcoming ENACT trial, which will focus on locally advanced pancreatic cancer [2][8] Group 4: Technology Overview - Acoustic Cluster Therapy (ACT) involves the intravenous administration of PS101, which is insonated over target tissue using ultrasound to enhance drug delivery [10][11] - The technology utilizes microclusters of perfluorobutane microbubbles and perfluoromethylcyclopentane microdroplets to improve the efficacy of concurrent chemotherapy [10][11]