South African skin cancer patients undergo first treatments with OncoBeta's Rhenium-SCT as part of the EPIC-Skin study

PRETORIA, South Africa - Amzeal -- OncoBeta® GmbH today announced the Steve Biko Academic Hospital in Pretoria, South Africa, is participating in the global phase IV EPIC-Skin Study (Efficacy of Personalised Irradiation with Rhenium-SCT – for the treatment of non-melanoma skin cancer).

The first South African patients were treated with Rhenium-SCT® at Steve Biko Academic Hospital on 25 November as it becomes the first medical facility in South Africa to participate in the EPIC-Skin study. The hospital has previously been treating skin cancer patients with Rhenium-SCT for compassionate use. The international study will follow the treatment of 210 adult patients and their progress over the next 24 months. The EPIC-Skin study is currently being conducted through study centres located in Australia, Austria, United Kingdom and Germany.

Professor Mike Sathekge, Head of Nuclear Medicine Research Infrastructure (NuMeRI) in South Africa, says, "South Africa is the country with the highest prevalence and incidence rates for NMSC in the entire African continent, with NMSC the fifth-most diagnosed cancer in the country.¹ These figures point to why it is so important that we continue to develop and test new treatments for skin cancer to improve patient outcomes."

Standard treatments for NMSCs are surgery-based, which can risk scarring or loss of function. Rhenium-SCT uses a non-invasive paste containing ß-emitting particles directly to the lesion, which target cancer cells without the need for surgery, in one session.^2-4

Patients in the EPIC-Skin study are asked to record their experiences via a user-friendly clinical study app. The study aims to measure patient-reported outcomes such as quality of life, treatment comfort and cosmetic outcomes, as well as further evaluating the efficacy of Rhenium-SCT for the treatment of NMSC.

Dr Gerhard Dahlhoff, Medical Director at OncoBeta GmbH, says, "The global incidence rates of NMSC continues to rise, with more than 7.7 million cases recorded each year^5,6 The EPIC-Skin study offers an opportunity to collect critical data to further investigate and validate the efficacy of Rhenium-SCT and the role it plays as a patient-friendly treatment alternative for NMSC."

"The patient journey is too often a difficult one. As a medical community it is important we remain committed to making this journey as easy, effective and efficient as possible by improving and developing new treatment options for patients with NMSC" adds Dr Dahlhoff.

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For more information about the EPIC-Skin clinical study, please visit: https://www.oncobeta.com/company/news

About the Rhenium-SCT (Skin Cancer Therapy)
Non-melanoma skin cancer (NMSC) is the most common form of cancer in humans.² The most common cause of NMSC is sun exposure, while other predisposing factors include genetic skin conditions and immunosuppressive diseases or treatments.⁷

The Rhenium-SCT is a painless*, single session^†, non-invasive therapy that provides aesthetic results, even in cases otherwise considered difficult to treat.^2-4 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 Rhenium-SCT is a precise, personalised^4,8 therapy that is only applied to the area needed to treat without affecting the healthy tissue. The specially designed device ensures the Rhenium-SCT compound never comes in direct contact with the patient's skin and the application is safe and simple for the applying physician. Most cases of NMSCs (Basal Cell Carcinomas and Squamous Cell Carcinomas) can be treated using the Rhenium-SCT in one single session.^†3 Scar-free healing of the treated lesion area and the regeneration of healthy tissue occurs usually within a few weeks after treatment.³

About OncoBeta
OncoBeta, with its headquarters located in Garching near Munich, Germany, is a privately held medical device company, specializing in the development and commercialization of state-of-the-art, innovative therapies. Since its foundation, OncoBeta has concentrated its efforts on the development, regulatory approval(s) and commercialization of the epidermal radioisotope therapy Rhenium-SCT (Skin Cancer Therapy), targeting NMSCs. OncoBeta has perfected the customized application and device management system in conformity with all health, safety and environmental protection regulatory standards.

Find out more about the Rhenium-SCT at www.oncobeta.com

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Forward-looking statements
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of OncoBeta's control, and which could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning OncoBeta's plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. OncoBeta undertakes no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

*No reported pain^2,4
†Complete tumour regression in 98.5% of lesions treated.³

References

1. International Agency for Research on Cancer. Data source: GLOBOCAN 2020. Graph production: Global Cancer Observatory. https://gco.iarc.fr/ (accessed November 2022).
2. Castellucci P, et al. High dose brachytherapy with non sealed 188Re (rhenium) resin in patients with non-melanoma skin cancers (NMSCs): single center preliminary results. Eur J Nucl Med Mol Imaging. 2021;48(5):1511-1521. doi: 10.1007/s00259-020-05088-z.
3. Cipriani C, et al. Epidermal Radionuclide Therapy - Dermatological High-Dose-Rate. Brachytherapy for the Treatment of Basal and Squamous Cell Carcinoma. In: Therapeutic Nuclear Medicine, editor Baum RP; New York: Springer, 2014.
4. Cipriani C, et al. Personalized irradiation therapy for NMSC by rhenium-188 skin cancer therapy: a long-term retrospective study. J Dermatolog Treat. 2020:1-7. doi: 10.1080/09546634.2020.1793890.
5. Global Burden of Disease Cancer Collaboration, et al. JAMA Oncol. 2019;5(12):1749-1768.
6. Ciążyńska M, et al. Sci Rep. 2021;11(1):4337.
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 March 2022).
8. Cipriani C, et al. Personalized high-dose-rate brachytherapy with non-sealed rhenium-188 in non-melanoma skin cancer. Int J Nucl Med. 2017;114–112.