EXACT Therapeutics announces positive clinical results from the ACTIVATE Phase I dose escalation
OSLO, September 26, 2023: EXACT THERAPEUTICS AS (“EXACT-Tx”, Euronext Growth: EXTX), a clinical stage precision health company utilising Acoustic Cluster Therapy (ACT®) across multiple therapeutic areas, today announces positive safety and anticancer activity results from the dose escalation part of the ACTIVATE trial. The data will be presented at a medical conference in early 2024.
"We are encouraged by these results from the dose escalation part of the trial. The results indicate that ACT treatment is tolerable and enhances the anticancer effect of chemotherapy in this hard-to-treat patient population. These results support the translation of our pre-clinical data and add confidence for further clinical development” says Dr Amir Snapir, CMO of EXACT Therapeutics.
Eight patients were enrolled into the dose escalation part of the study. The results suggest that ACT treatment in combination with FOLFOX or FOLFIRI is well tolerated without unexpected acute or delayed side effects of the ACT treatment or worsening of side effects of the chemotherapy. Positive anticancer responses have been seen in all but one of the evaluable patients in this hard-to-treat patient population, showing that the ACT treatment can enhance anticancer response to Standard of Care chemotherapy.
For more information, please contact:
Per Walday CEO EXACT Therapeutics Email: per.walday@exact-tx.com
About ACTIVATE:
The ACTIVATE study (“PS101-mediated ACT with Chemotherapy in Liver Metastases From Cancer of Gastrointestinal Origin, NCT04021277”) is a two-part Phase I dose escalation and dose finding study of PS101-mediated ACT combined with standard of care chemotherapy for the treatment of liver metastasis in patients with advanced solid tumours, with an expansion part in colorectal cancer (CRC) and pancreatic duct adenocarcinoma (PDAC) patients.
About EXACT-Tx:
EXACT-Tx is a clinical-stage Norwegian precision health company developing a technology platform for targeted therapeutic enhancement – Acoustic Cluster Therapy (ACT®). ACT® follows a unique approach to ultrasound-mediated, targeted drug enhancement – with the potential to significantly amplify the clinical utility of a wide range of therapeutic agents across a multitude of indications including within oncology (chemotherapy, immunotherapy) and brain diseases. www.exact-tx.com
About ACT®
• ACT® is a proprietary formulation consisting of microbubbles and microdroplets that are activated through the application of ultrasound with the consequent increase in targeted delivery of a co-administered therapeutic agent.
• ACT® is supported by a strong and broad preclinical package demonstrating therapeutic enhancement in multiple oncology models (pancreatic, breast, colon, prostate) as well as blood-brain barrier penetration.
• Initial focus of the Company is oncology, however the ACT® platform has potential across therapeutic areas (CNS, immunotherapy) and product classes.
Forward looking statements: This announcement and any materials distributed in connection with this announcement may contain certain forward-looking statements. By their nature, forward-looking statements involve risk and uncertainty because they reflect the Company's current expectations and assumptions as to future events and circumstances that may not prove accurate. A number of material factors could cause actual results and developments to differ materially from those expressed or implied by this forward-looking statement.