TRTH-12. Phase 1 Safety, Pharmacokinetic and Imaging Study of BLZ-100 Tumor Paint in Pediatric Brain Tumor Patients

Lee, Amy; Cole, Bonnie; Poliachik, Sandra L.; Ojemann, Jeff; Miller, Dennis M.; Novak, Julie; Hansen, Stacey; Olson, James; Leary, Sarah

doi:10.1093/neuonc/nox083.224

Cited by 2 publications

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“…The authors concluded that further clinical trials are justified. Lee and colleagues ( 49 ) are investigating the safety and utility of BLZ-100 in a phase I study in pediatric brain tumor patients; preliminary results have shown the agent to be safe and yielded fluorescence in 13/15 tumors, including 5/7 low-grade gliomas.…”

Section: Blz-100 (Tozuleristide Tumor Paint™; Peptide)mentioning

confidence: 99%

Receptor-Targeted Fluorescence-Guided Surgery With Low Molecular Weight Agents

et al. 2021

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Cancer surgery remains the primary treatment option for most solid tumors and can be curative if all malignant cells are removed. Surgeons have historically relied on visual and tactile cues to maximize tumor resection, but clinical data suggest that relapse occurs partially due to incomplete cancer removal. As a result, the introduction of technologies that enhance the ability to visualize tumors in the operating room represents a pressing need. Such technologies have the potential to revolutionize the surgical standard-of-care by enabling real-time detection of surgical margins, subclinical residual disease, lymph node metastases and synchronous/metachronous tumors. Fluorescence-guided surgery (FGS) in the near-infrared (NIRF) spectrum has shown tremendous promise as an intraoperative imaging modality. An increasing number of clinical studies have demonstrated that tumor-selective FGS agents can improve the predictive value of fluorescence over non-targeted dyes. Whereas NIRF-labeled macromolecules (i.e., antibodies) spearheaded the widespread clinical translation of tumor-selective FGS drugs, peptides and small-molecules are emerging as valuable alternatives. Here, we first review the state-of-the-art of promising low molecular weight agents that are in clinical development for FGS; we then discuss the significance, application and constraints of emerging tumor-selective FGS technologies.

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Section: Blz-100 (Tozuleristide Tumor Paint™; Peptide)mentioning

confidence: 99%

Receptor-Targeted Fluorescence-Guided Surgery With Low Molecular Weight Agents

et al. 2021

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Phase 1 Safety, Pharmacokinetics, and Fluorescence Imaging Study of Tozuleristide (BLZ-100) in Adults With Newly Diagnosed or Recurrent Gliomas

et al. 2019

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BACKGROUND Fluorescence-guided surgery (FGS) can improve extent of resection in gliomas. Tozuleristide (BLZ-100), a near-infrared imaging agent composed of the peptide chlorotoxin and a near-infrared fluorophore indocyanine green, is a candidate molecule for FGS of glioma and other tumor types. OBJECTIVE To perform a phase 1 dose-escalation study to characterize the safety, pharmacokinetics, and fluorescence imaging of tozuleristide in adults with suspected glioma. METHODS Patients received a single intravenous dose of tozuleristide 3 to 29 h before surgery. Fluorescence images of tumor and cavity in Situ before and after resection and of excised tissue ex Vivo were acquired, along with safety and pharmacokinetic measures. RESULTS A total of 17 subjects received doses between 3 and 30 mg. No dose-limiting toxicity was observed, and no reported adverse events were considered related to tozuleristide. At doses of 9 mg and above, the terminal serum half-life for tozuleristide was approximately 30 min. Fluorescence signal was detected in both high- and low-grade glial tumors, with high-grade tumors generally showing greater fluorescence intensity compared to lower grade tumors. In high-grade tumors, signal intensity increased with increased dose levels of tozuleristide, regardless of the time of dosing relative to surgery. CONCLUSION These results support the safety of tozuleristide at doses up to 30 mg and suggest that tozuleristide imaging may be useful for FGS of gliomas.

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TRTH-12. Phase 1 Safety, Pharmacokinetic and Imaging Study of BLZ-100 Tumor Paint in Pediatric Brain Tumor Patients

Cited by 2 publications

References 0 publications

Receptor-Targeted Fluorescence-Guided Surgery With Low Molecular Weight Agents

Receptor-Targeted Fluorescence-Guided Surgery With Low Molecular Weight Agents

Phase 1 Safety, Pharmacokinetics, and Fluorescence Imaging Study of Tozuleristide (BLZ-100) in Adults With Newly Diagnosed or Recurrent Gliomas

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