Austrian skin cancer patients take part in EPIC-Skin clinical study

MUNICH - March 15, 2022 - PRLog -- OncoBeta® GmbH today announces the first Austrian patients have been treated in the global phase IV EPIC-Skin Study (Efficacy of Personalised Irradiation with Rhenium-SCT– for the treatment of non-melanoma skin cancer).

Prof. Dr. Siroos Mirazei, Head of the Nuclear Medicine department at Ottakring Hospital in Vienna said, "This is an important step for better understanding efficacy and patient outcomes after treatment of non-melanoma skin cancer (NMSC) with Rhenium-SCT®. As the most prevalent cancer world-wide it is critical that we continue to look at ways to improve treatments and patient outcomes."

Today's patients are some of the first to be enrolled in the study with histologically confirmed stage I or II NMSC, and their progress will be followed up over a period up to 24 months. The international study will be conducted through study centres located in Austria, Australia, Germany, and the United Kingdom, with a planned total of 200 adult patients.

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 with Austria ranked 15th in the incidence of NMSC in the world.³ Traditional treatments for NMSCs predominantly involve surgery, which may have a risk of scarring or loss of function. Treatment with Rhenium-SCT employs a single session^†, non-invasive, superficial application of a radioactive compound containing ß-emitting particles directly to the affected area, which eliminate cancer cells without the need for surgery.^4-6

Dr Gerhard Dahlhoff, Medical Director at OncoBeta GmbH, says, "The role of radionuclide therapies in the treatment of many forms of cancers is becoming increasingly important. Rhenium-SCT is a new way of treating NMSCs through direct application to an affected area of any shape, without harming surrounding tissue. This minimises scarring and can have a profound effect on patient quality of life, where function or aesthetics are concerned."

OncoBeta CEO, Shannon D. Brown III says, "It's exciting what this study could mean for the future of NMSC treatment. We're not only reinforcing existing efficacy data of Rhenium-SCT but also asserting our focus on the patient's quality of life, treatment comfort and cosmetic outcomes."

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.

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

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About DSD Pharma
DSD Pharma is a distributor for diagnostics, theranostics and radiopharmaceutical/medical devices in the field of nuclear medicine and radiopharmaceuticals. DSD Pharma offers a product portfolio developed together at the forefront of research to its customers. This ensures the safety of latest technologies for the HCP and the best available diagnosis/theranosis/therapy for the patient.

Find out more about DSD Pharma at www.dsd-pharma.com

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 treated, with 89% after a single application⁶

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. World Cancer Research Fund. Skin Cancer Statistics. https://www.wcrf.org/dietandcancer/skin-cancer-statistics/ (accessed February 2022).
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 February 2022).