OSLO ,31 October 2023 :EXACT THERAPEUTICS AS ("EXACT-Tx", Euronext Growth: EXTX), a clinical stage precision medicine company utilising Acoustic Cluster Therapy (ACT®) across multiple therapeutic areas, today announces that theNorwegian Medicines Agency (NOMA) and the Ethics Committee have awarded all necessary approvals to start recruitment of patients into the dose expansion part of the ACTIVATE study inNorway . This follows the recently announced approval by theUK Medicines and Healthcare products Regulatory Agency (MHRA). The approvals means that EXACT-Tx may initiate recruitment of patients atOslo University Hospital for the dose expansion part of the ACTIVATE study. This part of the ACTIVATE study is designed to determine the dose level for further development and expand the safety and efficacy data of ACT in patients with metastatic colorectal cancer. 12 to 20 patients are planned to be enrolled into the dose expansion part of the ACTIVATE study. Per Walday, CEO, comments: "We are very pleased being able to start recruiting patients at theOslo University Hospital inNorway , in addition to the already included sites in theUK . A strong relationship with the clinical expertise inNorway is important to us and we look forward to start recruiting Norwegian patients into the dose expansion in ACTIVATE." For more information, please contact: Per Walday CEO EXACT Therapeutics Email: per.walday@exact-tx.com About EXACT-Tx: EXACT-Tx is a clinical-stage Norwegian precision medicine 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® o 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. o 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. o 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.
Click here for more information
© Oslo Bors ASA, source