TransMolecular initiates Phase I cancer trial

The target population for the study is adult patients with progressive or recurrent malignant glioma who have failed first-line, standard therapy. Radiolabeled 131Iodine-TM601 is being investigated in multiple cancer types through both local and intravenous delivery, including Phase II studies in malignant glioma and metastatic melanoma utilizing intravenous delivery. The current study utilizes an intravenous, unlabeled version of TM601.

Up to 36 patients will be enrolled in the Phase I dose-escalation trial. The study will be conducted at up to six clinical sites in the US. The primary study objectives are to determine the safety and tolerability of TM601, the target recommended Phase II dose, the biologically active dose of TM601 when administered intravenously, and the pharmacokinetics of TM601 at each dose level.

Patients will initially receive radiolabeled 131I-TM601 by intravenous (IV) infusion as an imaging agent to determine which patients demonstrate tumor-specific localization and uptake of the drug. Patients demonstrating tumor-specific uptake of 131I-TM601 on a brain SPECT scan will then receive treatment with non-labeled TM601 in this trial. One week following the imaging dose, study patients will receive non-labeled TM601 by IV infusion at various dosing levels once a week for three weeks and during additional cycles until disease progression is observed.

Alison Neill, vice president of medical affairs at TransMolecular, said: “Our discovery of the anti-angiogenic activity of TM601 has supported our decision to test its anti-cancer effects on its own, without linking it to radiation.”