First Patient Dosed in Ground-Breaking Clinical Investigation for OxSonics Therapeutics

05 January 2022

Oxford, UK – 5th January 2022 – OxSonics® Therapeutics, a world leader in the development of ultrasound-based drug delivery systems for the treatment of cancer, today announced that the first patient had been dosed in a first-in-human clinical investigation (ISRCTN17598292) evaluating its proprietary SonoTran® Platform.

SonoTran is being evaluated in a phase I/IIa multicentre clinical investigation in patients with metastatic colorectal cancer (mCRC) funded by the National Institute for Health Research (NIHR).

The clinical investigation includes three patient cohorts to evaluate:

the safety of the SonoTran Platform;
SonoTran’s ability to enhance the delivery of cetuximab and irinotecan into tumours in resectable mCRC patients; and
SonoTran’s ability to enhance tumour response to standard of care first-line chemotherapy (cetuximab + FOLFIRI) in unresectable mCRC patients.

Cohorts 1, 2 and 3 will recruit patients at the Oxford Cancer Centre, Churchill Hospital, Oxford University Hospitals (OUH) NHS Foundation Trust. Cohort 2 will additionally recruit patients at the Queen Elizabeth Hospital, Birmingham (UHB) NHS Foundation Trust. The coordinating investigator of the whole trial and the OUH site principal investigator is Professor Rachel Kerr (Department of Oncology, University of Oxford).

CEO and Co-founder Dr Colin Story commented: “Striving to deliver smarter and better therapies to help patients tackle tough-to-treat cancers is at the heart of everything we do, so we’re delighted that SonoTran is now being evaluated clinically. After more than ten years of innovative research at the University of Oxford’s Institute of Biomedical Engineering, followed by a further eight years of pre-clinical development by the world-leading multi-disciplinary team at OxSonics, we now enter a new and very exciting chapter in OxSonics’ evolution.”

Chair of the board Dr Allison Jeynes commented: “Whilst this first-in-human clinical trial is ongoing, Oxsonics is also advancing plans to initiate further trials with partnered therapeutic agents. These activities combined we believe will result in a pipeline of revolutionary products to treat unmet medical needs of patients with solid tumours.”

Coordinating and principal investigator Prof. Rachel Kerr commented: “Over the last quarter of a century, I have been involved in colorectal cancer trials, advancing patient care with novel therapeutics. Our improvement in response rates and increased survival, even with the most intelligently designed drugs, has always been hampered by our inability to deliver these agents deep into the tumour. I believe that SonoTran provides a real opportunity to increase the permeation of drugs deep into tumours, allowing a greater proportion of patients to achieve potential tumour resection and cure; and increasing life expectancy for the rest. The fact that this technology is something that could be applicable across many different tumour types and a whole array of anticancer drugs really drives our excitement about this trial across the cancer community”

– ENDS-

About OxSonics Therapeutics

OxSonics® Therapeutics’ proprietary platform technology, SonoTran®, is being developed to provide a step-change in the therapeutic index of anti-cancer agents without the development costs or delays associated with drug reformulation. SonoTran is designed to increase the dose and distribution of anti-cancer agents within solid tumours, thereby increasing the efficacy and/or reducing the toxicity of these agents across the majority of the most challenging solid tumour cancers.

The approach has been specifically designed to fit seamlessly into existing oncology clinical workflows, and has the major advantage of enabling healthcare professionals to see-as-they-treat by providing visualisation on-screen and in real time.

The SonoTran drug delivery platform is based on ground-breaking technological advances, originally invented at the University of Oxford’s Institute of Biomedical Engineering.

OxSonics is based in Oxford in the UK.

For more information please visit: www.oxsonics.com.

About the National Institute for Health Research (NIHR)

The mission of the National Institute for Health Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:

• Funding high quality, timely research that benefits the NHS, public health and social care;
• Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
• Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
• Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
• Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
• Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.

NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government. For more information please visit: www.nihr.ac.uk.

About metastatic Colorectal Cancer (mCRC)

Colorectal cancer (CRC) represents the third most common cancer worldwide and the fourth most common cancer-related cause of death. Approximately 15-25% of patients have metastatic CRC (mCRC) at diagnosis, and nearly half of CRC patients will develop metastases at some point during the course of the disease. The most common site for CRC metastases is in the liver (more than 50% of patients with metastatic CRC; and in 60% of these patients, liver metastases are the only site of spread).

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First Patient Dosed in Ground-Breaking Clinical Investigation for OxSonics Therapeutics