On December 18, 2019 Phoenix Solutions reported that at the Drug Development Unit at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust in London, the first patient in Phoenix’s first in human "ACTivate Trial" (NCT04021277) has received ACT in combination with chemotherapy for treatment of hepatic metastases associated with colorectal and pancreatic cancer (Press release, Phoenix Solutions, DEC 18, 2019, View Source [SID1234552490]).
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CEO Dr. Per Sontum: "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 Prof. Jeff Bamber’s Ultrasound and Optics Team at the ICR, and Prof. 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. 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."
Vice-chairman Sir Bill Castell, who joined the board of Phoenix over a year ago, further comments: "Whilst pursuing clinical development in combination with chemotherapy, we continue to explore with collaborators globally pre-clinical developments in new areas including cancer immuno-therapy, infectious diseases and enhancing drug delivery across the blood brain barrier. 2020 will be tremendously exciting in revealing the potential of ACT as a technology platform… ".
Chief Investigator Prof. Udai Banerji, Deputy Head of Drug Development at The Institute of Cancer Research, London, and The Royal Marsden said: "At our joint Drug Development Unit, we are very excited to start the clinical evaluation of ACT. 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."
The "ACTivate Trial" feature in BBC Breakfast, see: View Source
The "ACTivate Trial" featured at ICR’s website, see: View Source
The "ACTivate Trial" featured at RMH’s website, see: View Source
About Phoenix Solution and ACT
Phoenix Solutions AS is a privately held, Norwegian biotech company spun out from GE Healthcare, developing a proprietary technology platform for ultrasound mediated, targeted drug delivery – Acoustic Cluster Therapy (ACT). ACT comprises a unique microbubble /microdroplet formulation (PS101) for i.v. injection which, in combination with localized insonation with regular medical ultrasound, induces biomechanical effects that enable localized, controlled opening of the vascular barrier, leading to improved extravasation, distribution and uptake of co-administered drugs (e.g. chemotherapeutics) in the targeted tissues. 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.
About the ACTivate Trial
ACTivate is 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. Asides standard safety end points, the trial will evaluate 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. Additional end points include DW- and DCE-MRI examinations. 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.
Colorectal cancer is the third most common cancer worldwide and approx. 30% of patients with CRC will develop liver metastases during the course of their disease. Only some 25% of these are amenable to curative-intent treatment through metastatectomy. For this disease, targeted treatment of hepatic metastases with ACT has a range of potential applications including: as a part of a neo-adjuvant regime prior to resection to improve survival outcome, to downstage and increase the fraction of patients amenable for curative resection and, finally, to improve on survival outcome and palliation for non-resectable conditions.