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SonALAsense today announced the presentation of positive preliminary data from the ongoing Phase 1/2 SDT-201 study in Diffuse Intrinsic Pontine Glioma (DIPG).

SonALAsense today announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to the development program of SONALA-001 in combination with the INSIGHTEC Exablate 4000 Type-2 Device for the treatment of patients with diffuse intrinsic pontine glioma (DIPG).

SonALAsense, a pioneer in the development of non-invasive Sonodynamic Therapy using SONALA-001 in combination with Insightec’s MR-guided focused ultrasound, has appointed Ely Benaim, M.D., as Chief Medical Officer and Executive Vice President of Development.

SonALAsense today announced that the first cohort in SDT-202 was fully enrolled. SDT-202 is an open-label, dose-escalation trial of SDT in recurrent glioblastoma (rGBM).

Diffuse intrinsic pontine glioma (DIPG) is a rare and deadly pediatric brain cancer with a 2% five-year survival rate.

Company has received Safe to Proceed letters from FDA for two clinical trials in life-threatening brain tumors, DIPG trial is open and actively recruiting, it has expanded its executive leadership team and scientific advisory board and completed a Series B funding round.

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 noninvasive drug-device combination developed by SonALAsense in collaboration with Insightec.

Recent research suggests that it may be possible to categorize GBM into different subtypes based on the underlying biological mechanisms driving tumor development and growth.