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Fully recruited EPIC-Skin international study for the treatment of Non-Melanoma Skin Cancer

Garching n. Munich, Germany – OncoBeta® GmbH, a medical device company specialised in innovative epidermal radioisotope therapies, has confirmed the phase IV international multi-centre study designed to further evaluate the Complete Response Rate of patients with non-melanoma skin cancer after treatment with Rhenium-SCT® is now fully recruited.

The EPIC-Skin study (Efficacy of Personalised Irradiation with Rhenium-SCTfor 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 study aims 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.

Patients treated had a confirmed histopathology of stage I or II non-melanoma skin cancer. With the latest treatment round complete, all patients are now in the follow-up phase, which monitors quality of life, treatment comfort and cosmetic outcomes over the next 24 months. An interim analysis is expected to be published in mid 2023.

Professor Mike Sathekge, an internationally acclaimed researcher and current Head of Nuclear Medicine at Steve Biko Academic Hospital in Pretoria, South Africa, treated his first patient enrolled in EPIC-Skin in November 2022, and the latest patient marks the final treatment in the study.  

An international multi-centre trial, the EPIC-Skin study is being conducted across five countries and seven major cities including Rostock, Vienna, London, Pretroria, Gold Coast, Perth and Sydney with more than 180 patients taking part.

There are more than 7.7 million cases of NMSC each year, and incidence rates are increasing globally.3,4 Traditional treatments for NMSCs predominantly involve surgery, which carries a risk of scarring or loss of function. Treatment with Rhenium-SCT employs a non-invasive superficial application of a paste containing ß-emitting particles directly to the lesion, which eliminate cancer cells without the need for surgery.2,5,6

Dr. Gerhard Dahlhoff, Medical Director at OncoBeta® GmbH, stated: “We are excited to complete the final patient recruitment within EPIC-Skin as we will now start to receive data on the quality-of-life outcomes. With patients in study centres across Australia, Austria, Germany, United Kingdom and South Africa, we have a mix of patients, ethnicities, NMSC localisations and lesion characteristics which will enable us to even further evaluate the outcomes of treatment with Rhenium-SCT®.”

Shannon D. Brown III, CEO and Managing Director at OncoBeta® GmbH, said, “The patient journey is often a difficult one, so it is critical that the medical community continues to improve and develop new treatment options for patients with NMSCs. The EPIC-Skin clinical study has the potential to influence and change the way we evaluate and fit NMSC treatments to the individual needs and requirements of patients.”

 

ClinicalTrials.gov Identifier: NCT05135052

 

 

References

  1. Cipriani C, et al. International J Nucl Med. 2017; July:114–112
  2. Cipriani C, et al. J Dermatolog Treat. 2020; Jul 22:1-7.
  3. Global Burden of Disease Cancer Collaboration, et al. JAMA Oncol. 2019;5(12):1749-1768.
  4. Ciążyńska M, et al. Sci Rep. 2021;11(1):4337.
  5. Cipriani C, et al. In Therapeutic Nuclear Medicine, edited by R. P. Baum, New York: Springer, 2014.
  6. Castellucci P, et al.Eur J Nucl Med Mol Imaging. 2021; 48: 1511–1521.
  7. Cancer.net. Skin Cancer (Non-Melanoma): Risk Factors and Prevention. October 2020. https://www.cancer.net/cancer-types/skin-cancer-non-melanoma/risk-factors-and-prevention (accessed May 2023).
  8. Australian Therapeutic Goods Administration. ARTG Public summary 400142.
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