Clinical Accelerator and BetaGlue Technologies to conduct First in Human Medical Device Investigations in Breast Cancer and Liver Cancer

Clinical Accelerator is pleased to announce an exciting new collaboration with BetaGlue Technologies SpA. Two studies will be conducted, one on radio-ablation of surgical margins following resection of breast ductal carcinoma in situ (DCIS), in 20 patients and one of radio-ablation of malignant liver lesions – hepato-cellular carcinoma (HCC) – followed by surgical resection, in 10 patients.

Currently, surgery is the standard of care for resectable solid tumours. Loco-regional approaches combined with chemotherapy and/or radiotherapy are the standard therapy either before surgery to reduce tumoral mass or after surgery to reduce the risk of recurrence. Unfortunately, local recurrences and other complications are still a problem that needs to be remedied. BetaGlue, focusing specifically on these unmet needs and has developed a proprietary internal radiotherapy platform, composed of a 90Y β-emitting radioactive hydrogel matrix which has several clinical applications. Several administration devices have also been engineered or are in development for precise delivery and administration of this radio-active matrix.

The administration of β-emitting radionuclides has several advantages over external radiotherapy. There is improved efficacy, low impact on blood vessels, limited side effects and low surrounding tissue penetration. On the basis of the clinical experience accumulated in over 15 years of treatments based on trans-arterial infusion of 90Y-coated microspheres (Selective Internal Radio Therapy, SIRT, called also Trans Arterial Radio Embolization, TARE), it is reasonable to assume that the intra-tumoral injection of a personalized activity dose of 90Y, entrapped inside the matrix and directly into the hepato-cellular carcinomas, is expected to effectively ablate them and to reduce drastically the chances of local recurrence. Similarly, the administration of the appropriate activity of 90Y in the surgical bed of resected breast tumours should overcome the limitation of other radiotherapy techniques (intra-operative and/or external beam radiotherapy) and reduce drastically their chance of local recurrence, which occurs in the area of tumor resection in 95% of the cases.

The upcoming studies have the potential to pave the road for confirming the efficacy and safety of these applications. In breast cancer, after the cancerous region is removed, residual tumour cells are often left behind in the surgical bed. As part of the DCIS study, BetaGlue’s technology will be uniformly applied over the tumour bed, expectedly killing any residual tumoral cells through beta radiation. In the liver cancer study, once the tumour is identified, an introducer will be placed percutaneously into it and, through a proprietary delivery system, BetaGlue’s radioactive compound will be injected into the hepatic lesions, killing the tumoral cells. In both applications, once the radioactive charge is exhausted, the body will slowly reabsorb the bio-compatible matrix over time.

 About BetaGlue Technologies

 BetaGlue is a medical device company, founded in 2017 in Milano, Italy. Dr Antonino Amato CEO, Dr Pier Luigi Carriero, VP Clinical Operations and their team are dedicated to providing an innovative approach to fighting cancer with their proprietary β-emitting bio-compatible matrix, delivered through dedicated delivery systems. The company is supported by a highly qualified Scientific Advisory Board, and national/international consultants on intellectual property, product development and regulatory expertise.

  About Clinical Accelerator

Clinical Accelerator is a boutique academically oriented clinical CRO focused on the needs of emerging MedTech and Biotech companies. The organization conducts clinical trials in all main indications, with oncology being an important therapeutic area. Clinical Accelerator works with many excellent sites and investigators in Central and Eastern Europe, experienced in international clinical trials in the oncology field. The company offers clients a range of clinical trial services, including designing essential study documents, regulatory and ethics submissions, site selection and monitoring, safety reporting and medical monitoring, data management and biostatistics, medical writing and quality assurance.

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