BetaGlue Therapeutics SpA

BetaGlue Therapeutics Expands its Clinical Trial in Italy after obtaining from the Italian Ministry of Health Approval to conduct its clinical study in Unresectable Locally Advanced Pancreatic Cancer (uLA-PDAC)

MILAN, Dec. 02, 2025 (GLOBE NEWSWIRE) -- BetaGlue^® Therapeutics (“BetaGlue” or the “Company”) a pioneering Italian clinical-stage oncology company developing an innovative radiotherapy solution for the targeted treatment of solid tumours, is proud to announce that the Italian Ministry of Health (MOH) has approved its Clinical Trial Application for YntraDose^® in the treatment of unresectable Locally Advanced Pancreatic Ductal Adenocarcinoma (LA-PDAC). This authorization follows the recent Clinical Trial Approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

The clinical study, which is expected to begin enrolling patients in early 2026, with preliminary results expected by the end of the year, is an early feasibility clinical investigation designed to evaluate safety, usability and feasibility of YntraDose^® administration in patients with unresectable LA-PDAC which remains a significant health concern with limited effective treatment options and a pressing unmet medical need. YntraDose^® represents an innovative locoregional radiotherapy, utilizing Yttrium-90 microspheres embedded in a quickly polymerizing matrix to deliver targeted radiation directly to solid tumours. This approach has been designed with the aim to maximize therapeutic efficacy while minimizing damage to surrounding healthy tissue, offering new hope for patients facing unresectable locally advanced pancreatic cancer - one of the most aggressive and difficult-to-treat malignancies.

“As an Italian company, deeply committed to advancing cancer care, we are honoured to announce that the Italian Health Authorities have approved our clinical study in Italy, which will be conducted at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome. This achievement marks a fundamental step in our commitment to innovation in oncology and demonstrates the trust of Italian institutions in our technology and the therapeutic potential of YntraDose^® for patients with unresectable locally advanced pancreatic cancer” said Alexis Peyroles, CEO of BetaGlue Therapeutics. “We are grateful for the support of the Italian institutions and look forward to collaborating with the Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome bringing new hope to patients with unresectable locally advanced pancreatic cancer, one of the most challenging diseases worldwide. Looking ahead, we are actively planning to expand our clinical trials internationally, with the goal of making YntraDose^® available to patients in more countries and addressing unmet needs in cancer care worldwide.”

About BetaGlue Therapeutics
BetaGlue^® Therapeutics is a clinical-stage oncology company developing a novel radiotherapy platform technology for the localised and targeted treatment of unresectable solid tumours called YntraDose^® which is currently being evaluated for LA-PDAC and has further potential in other indications.

About YntraDose^®
YntraDose device is a locoregional therapy (LRT) intended for the percutaneous radio-ablation of unresectable solid tumors. It represents a novel technology that aim to deliver a targeted radiation dose using Yttrium-90 microspheres injected directly into the tumour site, within a glue matrix holding the Y-90 microspheres in place.

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