Acoustic Cluster Therapy (ACT) is a novel technology which enables spatially targeted delivery of drugs, for example to a tumor. Compared to a regular injection of drug (and passive uptake), such targeting to the disease area increases the therapeutic efficacy significantly, and potentially opens for reducing dose with ensuing reduction in side effects. In addition to a regular medicinal agent (for example a chemotherapeutic), ACT comprises the injection of a formulation of microbubbles followed by local insonation of the disease area with ultrasound. In the blood stream, the microbubbles respond to the sound wave by undergoing oscillations which in turn opens fenestrations (tiny openings) in the blood vessels and ensuing increased extravasation of the co-administered drug directly into the disease area.
To perform an optimal ACT procedure, the applied ultrasound needs to have certain characteristics with regards to sound frequency and strength. In addition, it needs to reach the entire disease area in a controlled manner. The objective of the current project is to develop an ideal ultrasound probe for use during the ACT procedure. This will enable ideal characteristics of the ultrasound field and a well-controlled insonation volume, enabling an optimal and fully targeted therapy.
The project targets to develop a spatially controlled, dual frequency ultrasound (US) transducer with accompanying control software, optimized for use during the Acoustic Cluster Therapy (ACT) procedure and meeting with all needs for a commercial phase product.
ACT is novel technology platform for ultrasound mediated, targeted drug delivery, offering a number of unique attributes vs. current standard of care approaches and holding a significant potential for solving major healthcare challenges. So far, ACT has been evaluated in combination with regular chemotherapy agents and pre-clinical development within this segment has shown the remarkable potential of the technology to increase the therapeutic efficacy of this class of cancer drugs. ACT is currently in clinical development in combination with Standard of Care chemotherapy for treatment of hepatic metastases from colon cancer. In addition, pre-clinical development with ACT and immune-oncology agents and with ACT for treatment of infectious diseases is ongoing.
In principal, ACT is a drug/device combination concept and, in order to deliver the full commercial potential of the technology, a bespoke US transducer with optimal attributes with regards to imaging, spatial focusing of US field outputs, and precise/accurate operator control is imperative.
The project comprises nine work packages covering three major development items; the physical probe, the console control software and a virtual navigation software to allow for full operator control with the treated tissue volume.
To execute the program EXACT has partnered with GE Vingmed Ultrasound AS. Vingmed is a world leading site for development and manufacture of US application and responsible for GE`s line of market leading US scanners and probes. Earlier, Vingmed has been instrumental in the development of the first prototype of a dual frequency, ACT® bespoke probe, currently used within the ongoing First-in-Man clinical trial.