Press release from Companies

Published: 2026-02-12 18:00:00

Double Bond Pharmaceutical International AB: Double Bond Pharmaceutical AB Signs Strategic Agreement for Landmark Clinical Study of Temodex® Based on Latest WHO Standards

   

UPPSALA, SWEDEN (February 12, 2026) – Double Bond Pharmaceutical AB (DBP) has signed a strategic research agreement with the N.N. Alexandrov National Cancer Centre in Belarus. This partnership initiates a study titled: "Study of the efficacy, safety, and therapeutic value of the drug Temodex in real-world clinical practice for the period 2021–2025."

   

    

A Scientific Milestone: Modern WHO Diagnostics

This study represents a significant step forward for brain cancer research. It is a comprehensive mapping of how the treatment performs in practice (Real-World Evidence) for glioblastoma, something that has previously been lacking on this scale.

Crucially, the analysis of data from 2021–2025 will be conducted exclusively using the latest WHO classification system, which shifted the diagnosis of GBM from purely histological observation to molecular genetic markers (such as IDH-wildtype status). By utilizing only the most recent diagnostic standards, DBP ensures that the study meets the highest scientific requirements of American and European regulatory authorities. This strengthens the evidence for the benefits of local chemotherapy with Temodex before the global medical community.

Validating SI-053 as a New Standard of Care

The research will compare a cohort of patients treated with Temodex against a specific control group of glioblastoma patients who received standard treatment without Temodex. To ensure the highest possible scientific rigor, both groups will be selected according to the same stringent and modern molecular WHO criteria. The study is expected to analyze data from a total population exceeding 450 patients, aiming to provide strong evidence for the clinical efficacy of Temodex in the treatment of GBM.

Strategic Impact on Partnering and Big Pharma

Beyond its scientific value, the study constitutes a central pillar of DBP’s commercial strategy. The results from this extensive five-year patient dataset are expected to significantly strengthen the company's position in ongoing negotiations with potential strategic partners.

Study Details

The project commenced on February 12, 2026, and is scheduled for completion by June 2026. The research will involve a full extraction of anonymized data from the "MEDIK Dispensary" system, utilizing unique code keys for each patient to ensure total confidentiality while providing high-fidelity clinical insights.

"This is a transformative moment for Double Bond Pharmaceutical," said Igor Lokot, CEO of Double Bond Pharmaceutical. "We are not just collecting data; we are analyzing a large patient population using the world's most stringent modern diagnostic standards. This study will prove that our technology changes the trajectory of brain cancer treatment and provides the ultimate validation needed to bring SI-053 to the forefront of global oncology through high-level partnerships. I am confident that these results will prove that SI-053 is a true game-changer in the treatment of GBM".

An audio deep-dive into the study:

More about N.N. Alexandrov National Cancer Centre: The Republican Scientific and Practical Center of Oncology and Medical Radiology named after N.N. Alexandrov is the premier cancer research and treatment facility in Belarus, specializing in advanced oncology care and medical radiology (www.omr.by/home-en)

More about SI-053: SI-053, an enhanced reformulation of Temodex, is a locally acting formulation of temozolomide. SI-053 received Orphan Drug Designation from the European Medicines Agency in 2016 and received multiple Competent Authority and Ethics Committee approvals from 2021 to 2023 to initiate a Phase 1 clinical study.  In a proof-of-concept study with human subjects conducted in 2015, SI-053 demonstrated significant overall survival benefit when added to the standard of care for glioblastoma.  Video presentation: https://youtu.be/iweOQPq316o


   

This disclosure contains information that DBP is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 12-02-2026 18:00 CET.

   

Information about Double Bond Pharmaceutical 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 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.

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Full Company Name:   Double Bond Pharmaceutical International AB (publ)

Corporate identity:       556991-6082

Stock short name:       DBP B

Share ISIN code:          SE0007185525

For more info, contact

Igor Lokot, CEO

Homepage: http://www.doublebp.com/

E-mail: info@doublebp.com

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