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An observational, multicentre, international, non-interventional programme to register patients diagnosed with non-melanoma skin cancer (NMSC), to monitor treatment outcomes and patterns of care at international hospitals
MUNICH - ncarol.com -- OncoBeta® GmbH announces the launch of a first-of-its-kind International Registry for NMSC. The launch is a momentous achievement for OncoBeta, and the clinicians seeking to understand data-driven treatment results for NMSC. OncoBeta will be launching the Registry alongside specialist health solutions partner, Avion Medical.
The International Registry will enable real-world patient data to be collected and reviewed in order to ascertain optimal methods of treating NMSC and for these to be applied internationally. It will give the patient the opportunity to contribute feedback and record patient experiences via the OncoBeta WeBe mobile app. The International Registry also allows the clinician community to be part of a credible project and a robust platform to publish useful long-term data.
The WeBe app allows for a streamlined approach to data collection. Dr. Gerhard Dahlhoff, Medical Director at OncoBeta said, "Data collection is so important for future research of NMSC, but it can be a time burden for busy healthcare professionals. The WeBe app aims to streamline the collection of important information, and allows patients to easily report quality of life data."
An independent committee made up of leaders in the dermatology and nuclear medicine community will oversee the International Registry. Paolo Castellucci from the committee stated, "This is an important registry for the future of NMSC treatment. It will allow researchers and clinicians internationally to develop new benchmark standards of care for recommending treatment options to patients."
One of the objectives of the registry is to collect treatment outcome data for several mainstay treatments of NMSC. This will be coupled with long term data collection that is currently limited for this type of cancer. An international registry of this kind does not currently exist, and can offer important insights as to which treatment modalities have the most positive long-term outcomes.
Medical Director for OncoBeta Australia, Dr Saima Vohra, says, "There has never been an opportunity like this in the NMSC space, to align the interests of healthcare professionals, and share outcomes globally. By having access to international data, we remove some of the restrictions that time and sample sizes put on research. Robust data sets give power to the international medical community to make informed decisions on how to best treat NMSC patients."
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The International Registry will complement and expand on current information held in isolated or smaller Registries and will provide details of the specific treatments of these cancers. The Registry will collect data across several disciplines fundamental to the management of NMSC.
"We are thrilled to be working with clinicians on an international scale to build rich, long-term data, which can be used to establish best practices for treating NMSC, and ultimately seek to increase quality of life for patients," says Shannon D. Brown III, CEO at OncoBeta GmbH.
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.1
The Rhenium-SCT® is a painless*, single session†, non-invasive therapy providing for unparalleled 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 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†4. Scar-free healing4 of the treated lesion area and the regeneration of healthy tissue occurs usually within a few weeks after treatment4.
About OncoBeta® GmbH
OncoBeta® GmbH, 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.
More on ncarol.com
Find out more about the Rhenium-SCT® at www.oncobeta.com
Follow us on social media:
LinkedIn: www.linkedin.com/company/oncobeta-gmbh/
Facebook: www.facebook.com/oncobeta/
Instagram: www.instagram.com/oncobeta_gmbh/
About Avion Medical
Avion Medical is a specialist health solutions partner, providing data management and clinical strategy consulting, specialising in Trials and Registries, for pharma, biotech and medical devices. Avion Medical's proprietary platform AviData Clinical Cloud enables seamless integration between patient inputs, imaging, lab data, eCRF and reporting; whilst ASTON Safety Reporting provides a comprehensive, web-based pharmacovigilance platform and database for processing and storing drug, device and vaccine adverse events. Avion Medical delivers specialised solutions for clinical research and product commercialisation.
Find out more about Avion Medical at www.avionmedical.com.au
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 pain2,3
†Complete tumour regression in 98.5% of lesions treated, with 89% after a single application4
References
The International Registry will enable real-world patient data to be collected and reviewed in order to ascertain optimal methods of treating NMSC and for these to be applied internationally. It will give the patient the opportunity to contribute feedback and record patient experiences via the OncoBeta WeBe mobile app. The International Registry also allows the clinician community to be part of a credible project and a robust platform to publish useful long-term data.
The WeBe app allows for a streamlined approach to data collection. Dr. Gerhard Dahlhoff, Medical Director at OncoBeta said, "Data collection is so important for future research of NMSC, but it can be a time burden for busy healthcare professionals. The WeBe app aims to streamline the collection of important information, and allows patients to easily report quality of life data."
An independent committee made up of leaders in the dermatology and nuclear medicine community will oversee the International Registry. Paolo Castellucci from the committee stated, "This is an important registry for the future of NMSC treatment. It will allow researchers and clinicians internationally to develop new benchmark standards of care for recommending treatment options to patients."
One of the objectives of the registry is to collect treatment outcome data for several mainstay treatments of NMSC. This will be coupled with long term data collection that is currently limited for this type of cancer. An international registry of this kind does not currently exist, and can offer important insights as to which treatment modalities have the most positive long-term outcomes.
Medical Director for OncoBeta Australia, Dr Saima Vohra, says, "There has never been an opportunity like this in the NMSC space, to align the interests of healthcare professionals, and share outcomes globally. By having access to international data, we remove some of the restrictions that time and sample sizes put on research. Robust data sets give power to the international medical community to make informed decisions on how to best treat NMSC patients."
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The International Registry will complement and expand on current information held in isolated or smaller Registries and will provide details of the specific treatments of these cancers. The Registry will collect data across several disciplines fundamental to the management of NMSC.
"We are thrilled to be working with clinicians on an international scale to build rich, long-term data, which can be used to establish best practices for treating NMSC, and ultimately seek to increase quality of life for patients," says Shannon D. Brown III, CEO at OncoBeta GmbH.
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.1
The Rhenium-SCT® is a painless*, single session†, non-invasive therapy providing for unparalleled 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 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†4. Scar-free healing4 of the treated lesion area and the regeneration of healthy tissue occurs usually within a few weeks after treatment4.
About OncoBeta® GmbH
OncoBeta® GmbH, 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
Follow us on social media:
LinkedIn: www.linkedin.com/company/oncobeta-gmbh/
Facebook: www.facebook.com/oncobeta/
Instagram: www.instagram.com/oncobeta_gmbh/
About Avion Medical
Avion Medical is a specialist health solutions partner, providing data management and clinical strategy consulting, specialising in Trials and Registries, for pharma, biotech and medical devices. Avion Medical's proprietary platform AviData Clinical Cloud enables seamless integration between patient inputs, imaging, lab data, eCRF and reporting; whilst ASTON Safety Reporting provides a comprehensive, web-based pharmacovigilance platform and database for processing and storing drug, device and vaccine adverse events. Avion Medical delivers specialised solutions for clinical research and product commercialisation.
Find out more about Avion Medical at www.avionmedical.com.au
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 pain2,3
†Complete tumour regression in 98.5% of lesions treated, with 89% after a single application4
References
- 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 October 2021).
- Cipriani C, et al. J Dermatolog Treat. 2020; Jul 22:1-7.
- Sedda AF, et al. Clin Exp Dermatol. 2008;33(6):745-749.
- 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.
Source: OncoBeta GmbH
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