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March 7, 2024

Clinical Trial for Pediatric Patients with Diffuse Intrinsic Pontine Glioma (DIPG)

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SonALAsense SDT-201 Phase 1/2 Clinical Trial for Pediatric Patients with Diffuse Intrinsic Pontine Glioma (DIPG)

SonALAsense is currently recruiting patients in a Phase 1/2 Clinical Trial in DIPG, which uses Sonodynamic Therapy (SDT). SonALAsense’s SDT is a noninvasive targeted combination of SONALA-001 (Intravenous Aminolevulinic Acid) and MR-guided focused ultrasound.

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Glioma cells, bladder cancer cells, skin cancer cells and other cancer cells have been shown to have a special need for a compound called aminolevulinic acid (ALA). When these cancer cells were given large amounts of ALA, they glowed pink when exposed to blue light. This finding led to ALA becoming a commercially available product (Gleolan®) that is used as a visual aid by neurosurgeons to help them identify and surgically remove aggressive brain tumors. Another ALA product (Cysview®) is used by urologists to identify bladder cancer cells that are otherwise difficult to find.

Actively Recruiting Sites:

  • San Francisco, CA - University of California
  • Washington DC - Children's National / Children's Research Institute
  • Miami, FL - Nicklaus Children's Hospital

SonALAsense knew more than 30 years ago that the same byproduct of ALA that made cancer cells glow could be activated to kill the cancer cells using high-energy light in a process called photodynamic therapy (PDT). PDT has a rapid onset of action and minimal effects on normal brain cells. Unfortunately, as SonALAsense tried to develop PDT to treat brain tumors they found that it required invasive and complex light delivery techniques making it difficult to develop. When it was reported that the same PDT process could be activated noninvasively using MR-guided focused ultrasound to produce light within the brain (sonodynamic therapy, SDT), they founded SonALAsense to bring this new, noninvasive cancer-specific treatment to patients as soon as possible.

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