Hope in the face of despair
SonALAsense SDT Indications
Recurrent Glioblastoma (rGBM)
Glioblastoma (GBM) patients face a dismal prognosis, with recurrence virtually inevitable. SonALAsense is pursuing clinical trials of SDT for the treatment of recurrent GBM.
Courtesy of Dr. Nader Sanai, Ivy Brain Tumor Center
GBM is one of the most aggressive primary brain tumors and has a grim prognosis. At this point GBM is incurable. The recurrence of GBM is inevitable, its management often unclear and case dependent.
People who suffer from GBM may also have challenges with their eyesight, seeing double, and with memory, walking and possibly have terrible headaches. Affected people may also feel exhausted much of the time. These symptoms may accelerate as the tumor grows, putting increasing pressure on the brain. Symptoms may advance aggressively depending on the location of the tumor.
The cause of GBM is a mystery. Efforts to ascertain factors that initiate the cancer have not pinpointed causation.
SonALAsense has had translational success from animal models to human trials
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.
Diffuse Intrinsic Pontine Glioma (DIPG)
DIPG is a type of pediatric brain tumor found in an area of the brainstem known as the pons.
Diffuse means that the tumor is not well-contained – it grows out into other tissue so that cancer cells mix with healthy cells. Intrinsic simply means “in”, referring to the point or origin. Pontine indicates that the tumor is found in a part of the brainstem called the pons. The pons is responsible for a number of important bodily functions, like breathing, sleeping, bladder control, and balance. Glioma is a general term for tumors originating from glial cells. Glial cells are found throughout the brain. They make up the white matter of the brain that surrounds and supports the neurons (neurons are cells that carry messages in the brain).
DIPG primarily affects children, with most diagnoses occurring between 5 and 7 years of age. It makes up 10-15% of all brain tumors in children, with about 300 new diagnoses per year in the United States. Unfortunately, fewer than 10% of children survive more than two years from diagnosis.
Phase 1/2 Clinical Trial in DIPG
SonALAsense is conducting an ascending energy- and drug dose-escalation study examining the safety, pharmacokinetics, and preliminary efficacy of sonodynamic therapy using SONALA-001 in combination with the Exablate 4000 Type-2 MR-Guided Focused Ultrasound device to treat patients diagnosed with DIPG.
Additional Brain Cancer Indications Under Consideration
Primary Glioblastoma (GBM)
Glioblastoma is the most frequent and malignant brain tumor. The vast majority of glioblastomas (~90%) develop rapidly de novo in elderly patients, without clinical or histologic evidence of a less malignant precursor lesion.
Courtesy of Dr. Nader Sanai, Ivy Brain Tumor Center
Brain metastases occur when cancer cells spread from their original site to the brain. Any cancer can spread to the brain, but the types most likely to cause brain metastases are lung, breast, colon, kidney and melanoma.
A meningioma is a tumor that arises from the meninges — the membranes that surround your brain and spinal cord. Meningioma is the most common type of tumor that forms in the head.
Additional Cancer Indications Pursued
Pancreatic cancer begins in the tissues of your pancreas — an organ in your abdomen that lies behind the lower part of your stomach. Your pancreas releases enzymes that aid digestion and produces hormones that help manage your blood sugar.
Gallbladder cancer is an abnormal growth of cells that begins in the gallbladder. Most gallbladder cancers are discovered at a late stage, when the prognosis is often very poor.
Bladder cancer is an abnormal growth of cells in the bladder. The bladder is a hollow muscular organ in the pelvis that stores urine.
Stomach cancer is an abnormal growth of cells in the stomach. The stomach is a muscular sac located in the upper abdomen. The stomach receives and holds the food you eat and then helps to break down and digest it.
Liver cancer is cancer that begins in the cells of your liver. Your liver is a football-sized organ that sits in the upper right portion of your abdomen, beneath your diaphragm and above your stomach.
Ovarian cancer is a growth of cells that forms in the ovaries. The cells multiply quickly and can invade and destroy healthy body tissue. Ovarian cancer treatment usually involves surgery and chemotherapy.
Phase 2 Clinical Trial in Recurrent GBM
SonALAsense is now recruiting for a 50 subject, 3-part Phase 2 trial in recurrent glioblastoma.