Our Science
targets cancer’s need for heme, creating a metabolic “smart bomb”
The combination of SONALA-001 and targeted MR-guided focused ultrasound sonodynamic therapy (SDT) is selective. SonALAsense’s SDT procedure noninvasively activates a “smart bomb” to trigger immediate and programmed cell death only in cancer cells.
SONALA-001 is a proprietary intravenous formulation of aminolevulinic acid (ALA). It is the first committed building block in the synthesis of the heme molecule, and the amount of ALA made in our bodies is controlled by the amount of heme.
The Heme Biochemical Pathway
ALA readily crosses the blood brain barrier where the brain tumor and other tumor cells absorb large quantities and convert it to protoporphyrin IX (PpIX), a precursor of heme. When PpIX is exposed to blue light it causes tumor cells to fluoresce pink – a visual aid in surgery. PpIX can also be activated by high-energy blue light to kill cells by creating reactive oxygen species (ROS). This process is called Photodynamic Therapy (PDT).
Protoporphyrin — A Beacon and a “Smart Bomb”
Protoporphyrin can be a beacon to the neurosurgeon through its use as a highly fluorescent visual aid when a special fluorescence detection microscope is used during surgery.
SonALAsense’s SDT Uses the Energy of Ultrasound to Produce Light Within the Brain to Activate Protoporphyrin IX, a Metabolite of SONALA-001
Images courtesy of Insightec
SDT uses the drug SONALA-001 in combination with the Exablate 4000 Type 2.0 MR-guided focused ultrasound device which delivers non-thermal energy to induce necrosis and apoptosis in gliomas.
“This Could Convert Brain Cancer from a Lethal Disease to a Manageable Chronic Illness"
Mitchel Berger, MD, Berthold and Belle N. Guggenheim Professor, Professor of Neurological Surgery, University of California, San Francisco, Director of UCSF’s Brain Tumor Center
Survival after Single Treatment of ALA SDT Optimized in Rat Study by SonALAsense Founder in Collaboration with MRgFUS Pioneer
A. Normalized tumor growth after tumor implantation for all treatment groups
B. Kaplan-Meier survival curves of tumor-bearing rats. Multi-point sonication method showed the greatest survival effect
How Sonodynamic Therapy Works
SonALAsense has had translational success from animal models to human trials
Video courtesy of Ivy Brain Tumor Center
Phase 1/2 DIPG (SDT-201)
Completed
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SDT-201 was our first Phase 1/2 dose-escalation study examining the safety, pharmacokinetics, and preliminary efficacy of ascending drug and energy dose combinations for sonodynamic therapy using SONALA-001 in combination with Exablate 4000 Type 2.0 MR-Guided Focused Ultrasound in subjects with diffuse intrinsic pontine glioma (DIPG).
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15 DIPG subjects have been treated to date. The results are being analyzed for presentation and publication.
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This trial identified the Recommended Phase 2 Dose of ultrasound energy for a subsequent clinical trial in DIPG.
For more details regarding the study, please visit our ClinicalTrials.gov listing:
Recent Positive Proof of Concept with SDT in Phase 0/1 Clinical Trial in Recurrent High Grade Gliomas (rHGG)
The Ivy Brain Tumor Center at Barrow Neurological Institute, the largest early-phase drug development program for brain cancer in the world, and SonALAsense have announced positive proof of concept of the first-in-human Phase 0/1 clinical trial of SDT in recurrent high-grade glioma patients. The initial results indicate SDT rapidly leads to targeted cell death in human glioma tissue. SDT was well-tolerated in all patients.