OxSonics Announces First-in-human Clinical Data Shows SonoTran(R) is Safe and Well-tolerated
OxSonics Therapeutics, a clinical-stage medtech company focused on transforming cancer treatment through SonoTran, its proprietary ultrasound-based drug delivery platform, today announces that first-in-human clinical data demonstrated that SonoTran is safe and well-tolerated, with consistent Particle activation observed and mapped using OxSonics’ proprietary “see-as-you-treat” technology.
The clinical data was presented by Dr Jeffrey Rubasingham, an oncologist at Oxford University Hospitals NHS Trust, Churchill Hospital, and the background and pre-clinical research by Professor Coussios, Statutory Chair of Biomedical Engineering at the University of Oxford and Director of the Oxford Institute of Biomedical Engineering, at the 28th European Symposium on Ultrasound Contrast Imaging, 19-20 January 2023.
The data is part of an ongoing Phase 1/2a multicentre clinical investigation funded by the National Institute for Health Research (NIHR), where SonoTran® is being evaluated in patients with metastatic colorectal cancer (mCRC). SonoTran® is in clinical development to enhance the delivery and improve the efficacy of oncology drugs, particularly targeted biological therapies that struggle to penetrate tumors. It combines innovative Particles that are independently co-administered with an anti-cancer drug, which are then activated by a novel ultrasound device at the tumor site, creating a localised pumping effect that increases the delivery and penetration of the drug throughout the tumor.
Nine patients were enrolled in the Safety Cohort, of which the primary objective was to evaluate the safety and tolerability of SonoTran® at three different doses of Particles, (three patients per dose). SonoTran® was safe and well tolerated at all three dose levels, with no serious adverse events reported. Particle activation (i.e. the generation of the Particle expansion and collapse that causes the localised pumping effect) at each dose level was also assessed using the Company’s “see as you treat” passive acoustic mapping technology. Consistent Particle activation was observed and mapped at all three dose levels. Based on these results, the lowest Particle dose (200mg) was selected for use in the Delivery and Efficacy Cohorts of the study, which are now both recruiting patients. The Delivery Cohort will assess how much SonoTran® can enhance the delivery of cetuximab and irinotecan into tumors in resectable mCRC patients and the Efficacy Cohort will evaluate SonoTran®’s ability to enhance tumor reduction when combined with standard of care first-line treatment (cetuximab and FOLFIRI), compared with the standard of care alone.
Dr. Marianna Lalla, Chief Medical Officer, OxSonics, commented: “We are delighted by our first-in-human clinical data, in which we see that SonoTran® is safe and well tolerated in patients. Pre-clinical data has shown that SonoTran® increases the tumour penetration of drugs, leading to reduced tumor size and increased survival, and we look forward to seeing if this is replicated in the clinic in the Delivery and Efficacy Cohorts.”
Jérôme Marzinski, Chief Executive Officer, OxSonics, commented: “This clinical data is an important milestone for OxSonics showing that SonoTran® is safe and well tolerated, as well as that the SonoTran® Particles were consistently activated at the lowest dose. We believe that this Particle activation will be able to translate to enhanced delivery of drugs into solid tumors and ultimately potentially transform cancer treatment.”
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