ALA Sonodynamic Therapy (SDT) Treatment
We are committed to providing hope in the face of despair with a unique proprietary non-invasive drug-device combination therapy, ALA Sonodynamic Therapy (SDT), for the treatment of recurrent glioblastoma multiforme (rGBM).
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Patient Centered Approach
Aminolevulinic acid (ALA) sonodynamic therapy (SDT) is created through the union of two FDA-approved technologies: ALA tumor targeting and focused ultrasound (FUS)
ALA SDT uses an MRI-guided focused ultrasound (MRGFUS) device together with a drug, aminolevulinic acid (ALA), to provide a cancer-specific therapeutic effect. We have compelling data from three independent groups (including SonALAsense’s founding CEO/CMO, Dr. Stuart Marcus) in three animal brain tumor models demonstrating >70% brain tumor regression and significant extension of survival without damage to surrounding normal brain tissue.
Both ALA and the MRGFUS device have been shown to be safe and well-tolerated in the brain as they are individually FDA-approved for other indications, allowing SonALAsense to begin a Phase 0/2 clinical trial in rGBM with no additional animal brain tumor model studies
Our goal is to turn glioblastoma multiforme (GBM) from a deadly cancer into a manageable disease, turning GBM patients into cancer survivors.
Metabolic Targeting of GBM
GBM cells have a unique metabolic signature different from normal brain cells, causing them to absorb large quantities of the drug aminolevulinic acid (ALA) and to convert it to a fluorescent molecule called protoporphyrin which neurosurgeons use as a visual aid to help them remove the GBM during surgery:
In addition to creating GBM-specific fluorescence, protoporphyrin can be “activated” by high energies of light in a process called ALA photodynamic therapy (PDT), which activates oxygen molecules in the cell and causes cell death. While ALA PDT is FDA-approved and used as topical therapy every day by dermatologists for skin pre-cancers (actinic keratoses), it has also been used experimentally to treat GBM. However, the process for treating GBM with ALA PDT is invasive and difficult to standardize. Fortunately, we and others have found that MRI-guided focused ultrasound (MRGFUS) can activate essentially the same process as ALA PDT and have developed it in animal models for that purpose; the process using MRGFUS instead of light to activate protoporphyrin is called sonodynamic therapy (SDT).
MRGFUS is FDA-approved for the noninvasive treatment of essential tremors as well as those arising from Parkinson’s disease. We have partnered with Insightec, the company that developed this tremor therapy, to use a similar device to activate ALA SDT in GBM.
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