Exact Therapeutics Announces Clinical Trial Update
OSLO/LONDON, 08 March 2022: EXACT THERAPEUTICS AS (“EXACT-Tx”, Euronext Growth: EXTX), a clinical stage precision health company utilizing Acoustic Cluster Therapy (ACT®) across multiple therapeutic areas, today provides an update regarding the phase I ACTIVATE study.
As reported in Q4 2021, EXACT-Tx filed a protocol amendment regarding its ACTIVATE phase I clinical trial with the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA). This week the MHRA issued a response to EXACT-Tx requiring an additional submission and approval of documentation regarding the protocol amendment. The Company expects that meeting this requirement which is specifically focused on the Ultrasound system used in combination with PS101, from the regulator will impact the timing of additional patient recruitment.
So far, there have been seven patients enrolled in the study with five patients’ data evaluable to date for dose limiting toxicity. A number of valuable and encouraging insights have been gained from this first cohort of treated patients.
ENDS
For more information, please contact:
Dominic Moreland
EXACT Therapeutics
Email: dominic@exact-tx.com
Optimum Strategic Communications
Eva Haas / Manel Mateus/ Vici Rabbetts
Tel: +44 (0) 208 078 4357
Email: Exact@optimumcomms.com
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), infectious diseases, 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 in oncology, however the ACT® platform has potential across therapeutic areas (infectious diseases, 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.