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DTI-015 is a formulation of carmustine (BCNU) dissolved in 100% ethanol for direct intratumoral injection. The ethanol solvent enables rapid and thorough perfusion of the tumor with the anticancer agent, allowing carmustine to enter both aqueous and lipid compartments within tumor tissue. This approach is designed for local treatment of malignant gliomas, particularly recurrent or inoperable glioblastoma multiforme (GBM). Clinical studies have shown that stereotactic administration of DTI-015 can be well tolerated at or below the maximally tolerated dose (MTD), with evidence of anti-tumor activity including stable disease and increased median survival times compared to historical controls. Preclinical models also demonstrated significant efficacy against aggressive brain tumors. The drug was developed by Direct Therapeutics and has received orphan drug status for this indication[1][3][4][6][7][9].
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