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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 recurrent GBM 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

SDT is a Platform Technology

SonALAsense is pursuing a Pipeline of additional indications utilizing SDT to treat multiple tumor types.

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.

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