DBP International AB: transition of the SI053 clinical trials protocol to a new Clinical Trial Information System has been completed

Double Bond Pharmaceutical International AB (publ) ("DBP" or "The Company", org. No. 556991-6082) is pleased to announce the successful transition of its clinical study "An open-label dose escalation study to estimate the maximum tolerated dose (MTD), identify dose-limiting toxicities (DLTs), and study pharmacokinetics following a single dose of intracranially administered temozolomide-based SI-053 as an add-on to the current standard of care (SoC) in adult patients with newly diagnosed glioblastoma (GBM)," to a new Clinical Trial Information System (CTIS). Adoption to this on-line system will be mandatory by February 2025 and is implemented to streamline trial management across all involved member states and to ensure compliance to the Clinical Trials Regulation.

"This is a significant formal step in preparing for the initiation of clinical trials for SI053”, comments Dr. Charlotta Grånäs Folkesson, CMO of DBP.

More about CTIS: https://euclinicaltrials.eu/

More about clinical trials of SI053: https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2024-515128-35-00, https://clinicaltrials.gov/study/NCT04967690?term=Double%20Bond%20pharmaceutical&rank=5

More about Temodex/SI-053: Temodex, which is a locally acting formulation of temozolomide developed by RI PCP in Minsk, Belarus, is registered for marketing as the first-line treatment of glioblastoma within Belarus since 2014. Temodex was acquired by DBP in autumn 2015 and is now being prepared under the name SI-053 to pass through all the tests and trials required for registration within the EU and globally. Video presentation: https://youtu.be/iweOQPq316o