A First-In-Human Study of BLZ-100 (Tozuleristide) Demonstrates Tolerability and Fluorescence Contrast in Skin Cancer

The document describes a study where 21 adult patients with known or suspected skin cancers were administered BLZ-100 (tozuleristide), a fluorescent imaging agent, to aid in the detection of malignant tissue during surgery. The patients received doses ranging from 1 to 18 mg. BLZ-100 was found to be well tolerated with no serious adverse effects reported. At doses of 3-12 mg, 90% of malignant lesions exhibited positive fluorescence. Gene expression analysis showed only modest differences between BLZ-100 positive and negative basal cell carcinoma tumors, indicating the agent's potential to distinguish between molecular subtypes of skin cancer. The study supports the safety of BLZ-100 up to 18 mg and suggests further research is needed to assess its efficacy in other solid tumors.