Double Bond Pharmaceutical AB (DBP) has announced the final results of a comprehensive retrospective study on Temodex, a treatment for malignant primary brain tumors. The study, involving 375 patients, has shown a statistically significant median overall survival (mOS) advantage of 5.6 months for patients receiving Temodex in addition to the standard of care (SoC). These findings reinforce the preliminary results and underscore the clinical efficacy of Temodex.

The study divided patients into two groups: 124 patients received Temodex along with SoC, while 251 patients received only SoC. The Temodex group exhibited a mOS of 15.6 months compared to 10.0 months in the control group. The hazard ratio of 0.61 and a p-value of 0.00062 further validate the significant survival benefit.

Igor Lokot, CEO of DBP, expressed satisfaction with the results, which align closely with initial findings. He emphasized the importance of continuing data analysis to integrate Temodex/SI-053 into SoC protocols effectively. The detailed analysis, including subgroup stratifications, will be presented at the EANS2026 congress.

Temodex, marketed as SI-053, is a reformulated version of temozolomide, designed for localized action. It has received Orphan Drug Designation from the European Medicines Agency, highlighting its potential in treating glioma. Given the promising data, stakeholders may consider a 'buy' recommendation for DBP, as the company positions itself for further growth and potential regulatory approvals.