Glioblastoma (GBM) remains the most aggressive and treatment-resistant primary brain tumor, with median overall survival rarely exceeding 15–20 months despite advances in surgery, imaging, and systemic therapy. The key barriers are persistent: incomplete resection, limited drug penetration across the blood–brain barrier (BBB), and a microenvironment that suppresses immune activity while promoting recurrence.
In response, the treatment landscape has broadened to include modalities such as CAR T-cell therapy, oncolytic viruses, and device-based approaches. Each introduces new mechanisms and possibilities, yet their practical roles are still being defined amid challenges of complexity, cost, and clinical integration.
In parallel, interest has returned to local chemotherapy as a direct and pragmatic countermeasure to these structural barriers. The experience with Temodex—a dextran-phosphate hydrogel delivering temozolomide (TMZ) directly into the resection cavity—suggested that very high local drug concentrations may prolong survival irrespective of MGMT methylation status, hinting at a pharmacologic route to bypass intrinsic resistance. SI-053 builds upon this principle, refining the hydrogel chemistry for controlled release, ensuring reproducible manufacture, and integrating seamlessly into existing neurosurgical workflows.
Rather than adding procedural complexity, it turns the surgical moment itself into a therapeutic opportunity—bypassing the BBB, saturating the cavity margin, and doing so in a way that is fast, broadacting, and immediately deployable across centers.
Authors: Double Bond Pharmaceutical
Keywords: glioblastoma, SI-053
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Double Bond Pharmaceutical International AB (publ)
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556991-6082
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DBP B
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SE0007185525
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Information on Double Bond Pharmaceutical International AB
DBP is a pharmaceutical company with the primary focus on development of therapies against cancer based on the company’s own developed drug delivery technology BeloGal®. The company was granted Orphan Drug Designation status by European Medicines Agency (EMA) in June 2015 for its first product, SA-033, for treatment of hepatoblastoma. Double Bond Pharmaceutical acquired rights to Temodex, a drug registered in Belarus for treatment of brain tumours, in October 2015, and was granted Orphan Drug Designation status by EMA for in July 2016 for this formulation of temozolomide for the treatment of glioma. The formulation is now being further developed for registration in EU and globally and has a working name SI-053 in DBP pipeline.