OncoBeta initiates international EPIC-Skin study with Rhenium-SCT® for the treatment of Skin Cancer
The multi-centre prospective study will evaluate the efficacy of the Rhenium-SCT® in non-melanoma skin cancer patients
Garching n. Munich, Germany– OncoBeta® GmbH, a medical device company specialized in innovative epidermal radioisotope therapies is pleased to announce the initiation of a phase IV international multi-centre study evaluating the Complete Response Rate of patients with nonmelanoma skin cancer after treatment with Rhenium-SCT®.
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”.