A key enhancement focuses on securing the quality of dextran phosphate, a critical excipient that forms SI-053's hydrogel with unique physical and chemical properties. The entire supply chain and manufacturing process comply with EU-cGMP standards and are fully localized within EU countries.

With this advancement, DBP is now prepared to commence manufacturing the material for the Phase 1 clinical trial. The study is designed as an open-label dose escalation and dose expansion trial to determine the maximum tolerated dose (MTD), identify dose-limiting toxicities (DLT), and establish the recommended Phase 2 dose (RP2D) of SI-053.

"This marks an important milestone in the development of SI-053, ensuring that we deliver a safe and high-quality product to patients, fully aligned with EU regulatory requirements," said Sanaz Peyrovan, Project Manager IMP of DBP.

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