Press release from Companies
Publicerat: 2026-02-19 18:03:00
UPPSALA, SWEDEN – February 19, 2026 – Double Bond Pharmaceutical AB (publ) (“DBP”) today presents preliminary results from an extensive retrospective evaluation of 484 patients treated for malignant primary brain tumors. The analysis is based on data from patients who underwent surgery between 2020 and 2025. The results indicate that the addition of the local chemotherapy Temodex to the surgical workflow provides a statistically significant survival advantage.
The results have been submitted for presentation at EANS2026 (European Association of Neurosurgical Societies).
Analysis of Survival Data
The preliminary analysis of the total cohort shows the following results for patients treated with Temodex compared to the control group:
Median Overall Survival (mOS): The treatment group exhibited a median survival of 14.3 months.
Control Group: The control group receiving standard-of-care (SOC) exhibited a mOS of 9.4 months.
Statistical Significance: The difference between the groups is statistically significant with a p-value of 0.0048.
The survival curves demonstrate an early and sustained separation, suggesting that the effect of the local treatment is consistent across the studied population.
Technical Background: From Temodex to SI-053
Temodex has been used clinically for over a decade in certain regions and constitutes the technical prototype for DBP’s global drug candidate SI-053. This real-world evidence (RWE) analysis establishes a baseline for the technology ahead of upcoming prospective clinical trials in Europe.
"These findings provide a clear indication of clinical efficacy," says Igor Lokot, CEO of Double Bond Pharmaceutical. "An extension of median survival by nearly five months in an unselected population is a significant result. We are using this data from Temodex as a foundation for the continued international development of SI-053."
Data Maturation and Scope
The study covers a heterogeneous patient group and includes both newly diagnosed glioblastoma (GBM) as well as cases of recurrent GBM. Ongoing work is now focused on an in-depth analysis where data is stratified based on histological subtypes, molecular markers, and degree of resection to further refine the results for specific subgroups.
An audio deep-dive into the study:
More about Real-World Evidence Study: https://mb.cision.com/Main/12720/4307158/3933333.pdf
More about EANS2026 Congress: https://eanscongress.org/
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 19-02-2026 18:03 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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