The first patient in has been enrolled in the ACTivate Trial, a Phase I/Ib trial aimed to evaluate the safety and tolerability of ACT (PS101 combined with local US insonation plus Standard of Care chemotherapy), for treatment of hepatic metastases from colon rectal and pancreatic cancer. ACTivate is evaluating the clinical efficacy of ACT with the primary end point being a differential analysis of RECIST response by CT, between insonated and non-insonated lesions in the same patient after 8-12 weeks. In addition to PS101 and ultrasound, patients with metastases from colon cancer will be dosed with standard regimens of either FOLFOX or FOLFIRI, whereas patients with metastases from pancreatic cancer will be dosed with nab-paclitaxel plus gemcitabine.
"At our joint Drug Development Unit, we are very excited to start the clinical evaluation of ACT,” said Chief Investigator, Professor Udai Banerji, Deputy Head of Drug Development at The Institute of Cancer Research, London and The Royal Marsden. “This represents an entirely novel approach to targeted drug delivery and is designed to significantly enhance the therapeutic efficacy of a number of chemotherapies used in the treatment of multiple cancers."
Acoustic Cluster Therapy (developed by Phoenix Solutions) comprises a unique microbubble /microdroplet formulation (PS101) for IV injection which, in combination with localised insonation with regular medical ultrasound, induces biomechanical effects that enable localised, controlled opening of the vascular barrier, leading to improved extravasation, distribution and uptake of co-administered drugs (e.g. chemotherapeutics) in the targeted tissues.
"We are extremely pleased to announce that Phoenix Solutions is now initiating the clinical development of ACT. After six years of technical work and pre-clinical development with Professor Jeff Bamber's Ultrasound and Optics Team at the Institute of Cancer Research, London, and Professor Catharina de Lange Davies at The Norwegian University of Science and Technology, the transition to the clinical phase is a very exciting moment for all of us, team and collaborators,” said Dr Per Sontum, CEO of Phoenix Solutions. “We look forward to moving to the next phase of the ACTivate study whose goal is to evaluate the clinical benefits of ACT, then also including Haukeland and Oslo University hospitals as clinical sites."
Pre-clinical Proof of Concept studies have shown that ACT improves markedly the efficacy of a wide range of therapeutic molecules and nano-drugs, in a wide range of disease models.