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Phase 0/1

Clinical Trial

Dr. Nader Sanai is conducting a Phase 0/1 clinical trial in recurrent high-grade gliomas (rHGG)

Nader Sanai, MD, Director of the Ivy Brain Tumor Center is conducting the first clinical trial of Sonodynamic Therapy (SDT) with SONALA-001 at the Ivy Brain Tumor Center at Barrow Neurological Institute. The Ivy Brain Tumor Center and SonALAsense have announced positive proof of concept in the first-in-human Phase 0/1 clinical trial of SDT in rHGG patients.

The initial results indicate SDT rapidly leads to targeted oxidative stress and cell death in human glioma tissue. SDT was well-tolerated in all patients.

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Phase 0/1 Clinical Trial Summary

Clinical trial data translated tumor cell death and biomarkers predictive of survival extension from non-clinical studies to recurrent high-grade glioma (rHGG) patients. SDT was well-tolerated and not associated with off-target effects. As predicted from preclinical models, the effects of SDT on human rHGG show:

  • Immediate cell death and apoptosis (programmed cell death), same mechanism of action as photodynamic therapy (PDT)

  • Rapidity of action (within 96 hours), similar to PDT

  • These biomarker results may indicate a high probability of increased survival in our Phase 2 SDT-202 trial in recurrent glioblastoma (rGBM) as seen in animal glioma models treated with ALA SDT and as reported for clinical trials of ALA PDT

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