Exact Therapeutics receives regulatory approval to reopen the ACTIVATE clinical trial

02 Feb 2023 13:13 CET

OSLO, 2 February 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 that the
United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has
approved reopening of the clinical phase I ACTIVATE trial.

As communicated in a press release of 8 March 2022, EXACT-Tx received a request
from the MHRA for an additional submission and approval of medical device
documentation associated to the protocol amendment filed with the ACTIVATE phase
I clinical trial. EXACT-Tx responded to the request and has now received MHRA’s
approval on both the medical device documentation and the amended protocol. The
approvals were made without objections.

For EXACT-Tx, this mean that the ACTIVATE phase I trial will be reopened and
additional patients will be recruited for the trial.

So far, there have been seven patients enrolled in the study with five patients’
data being evaluable for the study endpoints. Several valuable and encouraging
insights have been gained from this first cohort of treated patients.

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 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 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.

More information:
Access the news on Oslo Bors NewsWeb site

581242_2023-02 Exact Therapeutics - Clinical Trial Update.pdf