First Patient in Historic First-in-Human Clinical Trial for Glioblastoma

The Ivy Brain Tumor Center at Barrow Neurological Institute, the largest early-phase drug development program for brain cancer in the world, has announced the dosing of its first patient in a first-in-human Phase 0 clinical trial of sonodynamic therapy (SDT), a non invasive drug-device combination developed by SonALAsense in collaboration with Insightec. This historic study aims to develop a new non invasive treatment option for patients with recurrent glioblastoma (rGBM) and other high-grade gliomas.

“The potential value of an effective, non invasive treatment option for patients with glioblastoma cannot be overstated,” said Nader Sanai, MD, Director of the Ivy Brain Tumor Center. “We are uniquely positioned to rapidly assess the safety and biological impact of this ground breaking new strategy. In my career, I have never seen an approach quite like it.”

The Ivy Brain Tumor Center is evaluating sonodynamic therapy using Insightec’s magnetic resonance-guided focused ultrasound technology in combination with SonALAsense’s proprietary formulation of 5-aminolevulinic acid (Sonala-001) in a Phase 0 clinical trial. Sonala-001 is administered intravenously and metabolized selectively by tumor cells. The drug’s non-toxic by product is then activated using non invasive MR-guided focused ultrasound, enabling selective targeting of tumor cells without impacting the matrix of surrounding normal brain cells.

“This novel modality may prove to be an indispensable new tool for patients, families, and physicians racing against what is often a fatal disease and one that has not seen an FDA-approved drug in decades. The non invasive aspect of this treatment is particularly unique, as we are always looking to preserve patient quality of life while aggressively treating such tumors,” said Shwetal Mehta, PhD, Deputy Director and COO of the Ivy Brain Tumor Center.

The first patient treated with sonodynamic therapy was a 44-year-old man from Uruguay with a high-grade glioma. In his words: “I chose to be the first patient on this clinical trial because I wanted to do something for the greater good. I also wanted to do something that would make my daughters proud and show them I am doing everything in my power to fight this. From the time I was diagnosed three years ago, I have conducted extensive research on the latest therapies for brain cancer and this was at the top of my list. The treatment was non invasive, non-toxic, and targeted only the cancer cells, so I’m very happy to be a part of it.”

“It is exciting to see this breakthrough technology moving forward into clinical development for the benefit of brain cancer patients. We are pleased to be working with the experts at the Ivy Brain Tumor Center to conduct this study using their innovative Phase 0 clinical trial approach which will rapidly assess the effects of this first-in-class therapy. Our aim is to bring a non invasive treatment option to patients and make glioblastoma a manageable disease,” said Stuart Marcus, MD, PhD, Founder, CEO and CMO of SonALAsense.

 

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