clinical
trialsclinical trials overview
Current clinical trial program
TransMolecular is executing a multi-tiered clinical research program to explore the potential of radiolabeled and non radiolabeled TM601 in the treatment of high-grade glioma, malignant melanoma, and other aggressive cancers for which treatment options are limited. To date we have treated more than 150 patients in several cancer indications and plan to initiate studies in the ophthalmic disease neovascular age-related macular degeneration (wet AMD).
Radiolabeled TM601
Local delivery of radiolabeled TM601 (131I-TM601) is being evaluated in recurrent malignant glioma where novel therapies that can directly attack and infiltrate tumor cells while sparing normal cells are desperately needed. Interim analysis of a Phase 2 Efficacy study of TM601 administered intracavitarily in patients with recurrent malignant glioma has demonstrated improvement in survival compared to historical controls. This data is the basis of a Special Protocol Agreement TransMolecular has attained with the FDA to conduct a Phase 3 trial in newly diagnosed glioma where 131I-TM601 will be evaluated in combination with temozolomide and radiotherapy, the current standard of care. The SPA is a written agreement with FDA that a single protocol adequately meets scientific and regulatory requirements for NDA approval.
Radiolabeled TM601 is being evaluated with intravenous administration for the treatment of patients with a broad range of solid tumor types. Tumor specific uptake of 131I-TM601 after intravenous dosing has been demonstrated in 10 distinct cancer indications including: malignant glioma, malignant melanoma (including patients with brain metastases), colon cancer, non small cell lung cancer, prostate cancer, pancreatic cancer, breast cancer, transitional cell carcinoma, metastatic paraganglioma, and pleomorphic xanthoastrocytoma . Based on this encouraging data, Phase 2 studies of intravenously administered 131I-TM601 have been initiated in malignant glioma and metastatic melanoma.
Non-radiolabeled TM601
Ongoing research has shown that non-labeled TM601 also has potential anti-cancer properties through an inhibitory effect on angiogenesis or new blood vessel formation. Based on these data and the tumor targeting ability of TM601, the unlabeled compound is now being tested for safety and biological activity in a Phase 1 clinical study in malignant glioma. This Phase 1 study of systemically delivered TM601 in patients with recurrent glioma will study the biological activity as measured by MRI perfusion imaging changes. This study is designed to evaluate the safety and biologic effect of TM601 associated with angiogenesis inhibition.