SonALAsense Presents Preliminary Data From Clinical Study in Patients With Deadly Pediatric Brain Tumor

Tumor Regression and Improved Patient Performance are Among the Early Findings

Excerpt from the Press Release:

OAKLAND, Calif.–(BUSINESS WIRE)–SonALAsense, a pioneer in the development of non-invasive Sonodynamic Therapy (SDT) using SONALA-001 (aminolevulinic acid HCl) in combination with Insightec’s Exablate 4000 Type-2 ultrasound device today announced the presentation of positive preliminary data from the ongoing Phase 1/2 SDT-201 study in Diffuse Intrinsic Pontine Glioma (DIPG). These results were presented at the November 2023 Society for Neuro-Oncology (SNO) Annual Meeting in Vancouver, Canada. The preliminary data from Study SDT-201 shows signals of clinical activity and no safety concerns.

Study SDT-201 is a dose escalation and expansion study in patients with DIPG. Six (6) patients have been treated to date and dose escalation is ongoing. No dose limiting toxicities (DLTs) have been observed and there have been no serious adverse events. There were no treatment related deaths observed. One international patient discontinued for personal reasons and there was one patient death due to metastasis outside of the treated area.

“The preliminary safety, tumor response and clinical performance data we are seeing has the potential to translate into meaningful benefit for these children and their families,” said Ely Benaim, M.D., SonALAsense’s Chief Medical Officer and Executive Vice President of Development. “Currently, radiotherapy is the primary standard of care and many patients are also prescribed steroids. However, these current interventions have the potential for severe side effects.”

Click the button below to read the entire Press Release:

Continue Reading The Press Release