EPIC-Skin study welcomes world-first skin cancer patients treated with OncoBeta's Rhenium-SCT

MUNICH - March 10, 2022 - PRLog -- OncoBeta® GmbH has today announced a world-first from Australia, with the first patients treated with Rhenium-SCT® as part of the global phase IV EPIC-Skin Study (Efficacy of Personalised Irradiation with Rhenium-SCT – for the treatment of non-melanoma skin cancer [NMSC]).

These Australian patients are the first of 200 adults in the study, and their progress will be followed over the next 24 months. The international study will be conducted through study centres located in Australia, Austria, Germany and the United Kingdom. Australia will host multiple study centres in selected capital cities, with these patients the first to be treated globally at South Coast Radiology located within Gold Coast's John Flynn Private Hospital.

The first patients in the study were treated on 25^th February by GenesisCare's Radiation Oncologist, Associate Professor Siddhartha Baxi, after being successfully trained and certified by the team at OncoBeta. A/Prof. Baxi said, "This study presents an important opportunity for the international medical community to better understand NMSC treatment, and to further evaluate this new non-invasive epidermal radioisotope therapy. Australia has the highest incidence of NMSCs in the world, so it is imperative that we investigate new treatment options and continue to improve patient outcomes."

The EPIC-Skin study has an emphasis on Patient Reported Outcome Measures 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. Patients in the study will utilise OncoBeta's Clinical Study app, providing a simple and streamlined way to record their experiences.

There are more than 7.7 million cases of NMSC each year, and incidence rates are increasing globally. ^1,2 Traditional treatments for NMSCs predominantly involve surgery, which may have 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.^3-5

Dr Gerhard Dahlhoff, Medical Director at OncoBeta GmbH, says, "Rhenium-SCT offers a new way of treating NMSC. The role of nuclear medicine in the treatment of many forms of cancers is becoming increasingly important. Rhenium-SCT can be applied directly to an affected area, without harming or scarring surrounding tissue. This can have a profound effect on patient quality of life, where function or aesthetics are concerned."

OncoBeta Australia Country Manager, Ken Rikard-Bell, says, "With rates of NMSC on the rise in Australia and around the world, it's vitally important that treatments are continuously improving and innovating. It's exciting what this study could mean for the future of NMSC treatment. Never before has there been such an ability to fit the treatment to the patient."

OncoBeta has partnered with Australian Nuclear Science and Technology Organisation (ANSTO) to produce the Rhenium-SCT® compound for the treatment of non-melanoma skin cancer.

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.⁶

The Rhenium-SCT® is a painless*, single session^†, non-invasive therapy providing for unparalleled aesthetic results, even in cases otherwise considered difficult to treat.^3-5 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.^†5 Scar-free healing of the treated lesion area and the regeneration of healthy tissue occurs usually within a few weeks after treatment.⁵

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^3,4
†Complete tumour regression in 98.5% of lesions treated, with 89% after a single application⁵

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. Cipriani C, et al. J Dermatolog Treat. 2020; Jul 22:1-7.
4. Sedda AF, et al. Clin Exp Dermatol. 2008;33(6):745-749.
5. 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.
6. 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).