German skin cancer patients join the EPIC-Skin study

ROSTOCK, Germany - Amzeal -- OncoBeta® GmbH has announced University Clinic of Rostock (is particpating in the global phase IV EPIC-Skin Study (Efficacy of Personalised Irradiation with Rhenium-SCT – for the treatment of non-melanoma skin cancer [NMSC]) treating its first patients with Rhenium-SCT® as part of the international study.

The first German patients were treated on 21^st July, and are now part of 210 adults participating in the international study that will follow their progress over the next 24 months. The EPIC-Skin study is being conducted through study centres located in Australia, Austria, United Kingdom and Germany.

Rhenium-SCT® has been used in Rostock and in other parts of Germany as an NMSC treatment for some time. In addition to this EPIC-Skin Study, The University Clinic of Rostock has also been involved in a local clinical study using Rhenium-SCT, with results due to be presented later this year.

Treating physician in the EPIC-Skin study - University Clinic of Rostock, Dr. Martin Heuschkel (Nuclear Medicine) said, "Rhenium-SCT® is viewed as a favourable treatment due to its ability to be applied directly to an affected area, without harming or scarring surrounding tissue. This study presents the unqiue opportunity to further evaluate this new non-invasive epidermal radioisotope therapy and its long-term efficacy in improving patient outcomes."

There are more than 7.7 million cases of NMSC each year, and incidence rates are increasing globally^1,2 with Germany currently ranked 8^th in the world³. Standard treatments for NMSCs are surgery-based approaches, which may have a risk of scarring or loss of function. Rhenium-SCT® uses a non-invasive paste containing ß-emitting particles directly to the lesion, which eliminate cancer cells without the need for surgery, in one single session.^4-6

Dr Gerhard Dahlhoff, Medical Director at OncoBeta GmbH, says, "The role of the EPIC-Skin Study is not to challenge the existing treatment options but rather to show Rhenium-SCT® is a treatment alternative with which NMSCs can be cured effectively, with a strong focus on patient perspectives."

The EPIC-Skin study will 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. To provide a simple and streamlined way to record their experiences, patients in the study will utilise OncoBeta's Clinical Study app.

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Shannon D. Brown III, CEO and Managing Director at OncoBeta, says, "OncoBeta's goal is to provide the best innovative solutions for patients suffering from NMSCs. Rostock is the second centre in Europe participating in the EPIC-Skin study provding important multi-centre data that will offer new insights in the treatment of NMSC's and the role of Rhenium-SCT® as a treatment alternative for patients."

Clinicians who are interested in enrolling patients in the study can contact OncoBeta directly at www.oncobeta.com/contact.

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 providing for unparalleled aesthetic results, even in cases otherwise considered difficult to treat.^4-6 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 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.^†6 Scar-free healing of the treated lesion area and the regeneration of healthy tissue occurs usually within a few weeks after treatment.⁶

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.

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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^4,5
†Complete tumour regression in 98.5% of lesions treated⁶

References

1. Global Burden of Disease Cancer Collaboration, et al. JAMA Oncol. 2019;5(12):1749-1768.
2. Ciążyńska M, et al. Sci Rep. 2021;11(1):4337.
3. https://www.wcrf.org/cancer-trends/skin-cancer-statistics/
4. Cipriani C, et al. J Dermatolog Treat. 2020; Jul 22:1-7.
5. Sedda AF, et al. Clin Exp Dermatol. 2008;33(6):745-749.
6. Cipriani C, Sedda AF. 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.
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 November 2021).