OncoBeta receives ethics approval for EPIC-Skin study to evaluate Rhenium-SCT in Australia
21st December 2021
Garching b. Munich, Germany – OncoBeta® GmbH, a medical device company specialized in innovative epidermal radioisotope therapies announced today that the company has received ethics approval from the National Health and Medical Research Council (NHMRC) in Australia to begin the phase IV clinical study of Rhenium-SCT® to further evaluate the Complete Response Rate of patients with non-melanoma skin cancer.
The EPIC-Skin Study (Efficacy of Personalised Irradiation with Rhenium-SCT– for the treatment of non-melanoma skin cancer) will enrol 210 adult patients with a histological confirmation of stage I or II non-melanoma skin cancer to participate for 12 months, with a follow up period up to 24 months.
OncoBeta has contracted the Australian based Clinical Research Organization (CRO), Molecule2Market for this significant international, multicentre clinical study.
Dr. Gerhard Dahlhoff, Medical Director at OncoBeta stated, “This is a fantastic achievement. Receiving ethics approval marks an important milestone for this study, and the distribution of this therapy for non-melanoma skin cancer. It brings OncoBeta one step closer to helping safely and effectively treat patients around the world”.
NHMRC ethics approval ensures the adherence to consistent safety monitoring and reporting of clinical trials that aligns with the Therapeutic Goods Administration (TGA) and guidance for Safety Monitoring and Reporting in Clinical Trials in relation to Australian and international research practices.
Shannon D. Brown III, CEO and Managing Director at OncoBeta, says “We are dedicated to developing and improving world-class non-invasive therapies in the areas of dermatology and oncology for patients in need. This milestone ethics approval demonstrates our commitment to transparency, safety and improved patient quality of life.”
Treatment with Rhenium-SCT has already been shown to be effective in the treatment of basal cell (BCC) and squamous cell carcinomas (SCC)1,2. Medical Director for OncoBeta Australia, Dr Saima Vohra, says “This study will have a specific emphasis on Patient Reported Outcome Measures, and quality of life, as well as further confirmation of the efficacy of Rhenium-SCT for the treatment of NMSC.”
The study will commence in January 2022, with the first patients scheduled for treatment with Rhenium-SCT at Royal North Shore Hospital in North Sydney. Clinic sites participating in the study include Austria, Germany, United Kingdom and five cities in Australia. Those interested in referring patients to the study, can contact OncoBeta directly at https://www.oncobeta.com/contact.