OncoBeta initiates international EPIC-Skin study with Rhenium-SCT® for the treatment of Skin Cancer

MUNICH - Rezul -- – 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 non-melanoma 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."

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"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 results^2,4, 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.

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-theart, 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 non-melanoma skin cancers. 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.

References

1. Castellucci P, et al. High dose brachytherapy with non-sealed 188Re (rhenium) resin in patients with non-melanoma skin cancers (NMSCs): single centre preliminary results. Eur J Nucl Med Mol Imaging. 2021; 48: 1511–1521.
2. Cipriani C, et al. Personalized irradiation therapy for NMSC by rhenium-188 skin cancer therapy: a long-term retrospective study. Journal of Dermatological Treatment. 2020. DOI: 10.1080/09546634.2020.1793890
3. Sedda A F, et al. Dermatological high-dose-rate brachytherapy for the treatment of basal and squamous cell carcinoma. Clinical and Experimental Dermatology. 2008; 33: 745–749.
4. 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, edited by R. P. Baum, New York: Springer, 2014.