On September 9, 2021 OncoBeta GmbH, a medical device company specialized in innovative epidermal radioisotope therapies reported the initiation of a phase IV international multi-centre study evaluating the Complete Response Rate of patients with non-melanoma skin cancer after treatment with Rhenium-SCT (Press release, OncoBeta, SEP 9, 2021, View Source [SID1234587567]).
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The EPIC Skin study (Efficacy of Personalised Irradiation with Rhenium-SCT- for the treatment of non-melanoma skin cancer) is based on the proven effect of the ß-emitter rhenium-188 in the treatment of basal cell (BCC) and squamous cell carcinomas (SCC)1,2. The Aim of the study is to further evaluate the efficacy of Rhenium-SCT as well as important Patient Reported Outcome Measures such as quality of life, treatment comfort and cosmetic outcomes.
OncoBeta has contracted the Australian based Contract Research Organization (CRO) Molecule2Market (M2M) for this significant international, multicentre clinical study (www.molecule2.com.au).
The study will enrol a minimum number of 175 adult patients with a confirmed histologically of stage I or II non-melanoma skin cancer to participate for 12 months, with a follow up period to 24 months. Study centres participating in the initiative are located in Australia, Austria, Germany and the United Kingdom. Enrolment for the EPIC-Skin trial is expected to open as soon as November 2021.
Dr. Gerhard Dahlhoff, Medical Director at OncoBeta GmbH stated: "Rhenium-SCT has proven to be effective and safe in previous studies. With this new study we want to further evaluate the efficacy and safety of the Rhenium-SCT at an international level in NMSC patients. This will be done in different centres under the same conditions."
"The initiation of the EPIC-Skin Study is a significant milestone for the Rhenium-SCT", said Shannon D. Brown III, CEO and Managing Director at OncoBeta GmbH "This will further demonstrate how effective and safe this therapy is. Furthermore, aligning with our company vision of focussing on quality of life, this study will also report on outcomes from the patient’s perspective."
About the Rhenium-SCT (Skin Cancer Therapy)
Non-melanoma skin cancer (NMSC) is the most common form of cancer in humans. The most common cause of NMSC is sun exposure, while other predisposing factors include genetic skin conditions and immunosuppressive diseases or treatments. The Rhenium-SCT is a non-invasive procedure, painless therapy3 providing for unparalleled aesthetic results2,4, even in cases otherwise considered difficult to treat.
The Rhenium-SCT utilizes the radioisotope Rhenium-188 in an epidermal application with optimal properties for the treatment of NMSCs (non-melanoma skin cancers). The specially designed device ensures the Rhenium-SCT compound never comes in direct contact with the patients’ skin and the application is safe and www.oncobeta.com simple for the applying physician. Most cases of non-melanoma skin cancers (Basal Cell Carcinomas and Squamous Cell Carcinomas) can be treated using the Rhenium-SCT in one single session3. Scar-free healing4 of the treated lesion area and the regeneration of healthy tissue occurs usually within a few weeks after treatment4.