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DRUG:

ALA sonodynamic therapy

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Other names: ALA sonodynamic therapy, Sonala-001, Sonala-001 SDT, 5-aminolevulinic acid SDT, 5-aminolevulinic acid sonodynamic therapy
Associations
Company:
INSIGHTEC, Ivy Brain Tumor Center, SonALAsense
Drug class:
Photosensitizer
Associations
2ms
A Phase 2 Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Patients with DIPG (clinicaltrials.gov)
P2, N=15, Suspended, SonALAsense, Inc. | Trial completion date: Jul 2024 --> Oct 2024 | Terminated --> Suspended
Trial completion date • Trial suspension • Combination therapy
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ALA sonodynamic therapy
4ms
A Phase 2 Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Patients With DIPG (clinicaltrials.gov)
P2, N=15, Terminated, SonALAsense, Inc. | N=40 --> 15 | Trial completion date: Aug 2025 --> Jul 2024 | Active, not recruiting --> Terminated; The study is terminated due to lack of funding but not due to safety concerns.
Enrollment change • Trial completion date • Trial termination • Combination therapy
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ALA sonodynamic therapy
4ms
A Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Subjects With Recurrent GBM (clinicaltrials.gov)
P1/2, N=8, Terminated, SonALAsense, Inc. | Trial completion date: Nov 2026 --> Jul 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Apr 2026 --> Jun 2024; Study is terminated due to funding challenges and not due to safety concerns.
Trial completion date • Trial termination • Trial primary completion date • Combination therapy
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ALA sonodynamic therapy
4ms
A Phase 2 Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Patients With DIPG (clinicaltrials.gov)
P2, N=40, Active, not recruiting, SonALAsense, Inc. | Recruiting --> Active, not recruiting
Enrollment closed • Combination therapy
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ALA sonodynamic therapy
8ms
Study of Sonodynamic Therapy in Participants With Recurrent High-Grade Glioma (clinicaltrials.gov)
P1, N=30, Recruiting, Nader Sanai | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary completion date
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CASP3 (Caspase 3)
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ALA sonodynamic therapy
9ms
Phase classification • Combination therapy
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ALA sonodynamic therapy
9ms
A Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2.0 in Subjects With Recurrent GBM (clinicaltrials.gov)
P1/2, N=8, Active, not recruiting, SonALAsense, Inc. | Recruiting --> Active, not recruiting | N=44 --> 8
Enrollment closed • Enrollment change • Combination therapy
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ALA sonodynamic therapy
over1year
A Phase 1/2 Study of Sonodynamic Therapy Using SONALA-001 and Exablate 4000 Type 2 in Patients With DIPG (clinicaltrials.gov)
P1/2, N=27, Recruiting, SonALAsense, Inc. | Phase classification: P2 --> P1/2 | N=18 --> 27
Phase classification • Enrollment change • Combination therapy
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ALA sonodynamic therapy
over1year
Study of Sonodynamic Therapy in Participants With Recurrent High-Grade Glioma (clinicaltrials.gov)
P1, N=30, Recruiting, Nader Sanai | Trial completion date: Mar 2023 --> Mar 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
Trial completion date • Trial primary completion date
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CASP3 (Caspase 3)
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ALA sonodynamic therapy
over2years
Study of Sonodynamic Therapy in Participants With Recurrent High-Grade Glioma (clinicaltrials.gov)
P1, N=30, Recruiting, Nader Sanai | Trial completion date: Mar 2022 --> Mar 2023 | Trial primary completion date: Dec 2021 --> Dec 2022
Trial completion date • Trial primary completion date
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CASP3 (Caspase 3)
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ALA sonodynamic therapy
3years
A First-in-Human Phase 0/1 Clinical Trial of 5-Aminolevulinic Acid Sonodynamic Therapy in Recurrent Glioblastoma (SNO 2021)
Six hours prior to SDT, adult patients with recurrent GBM are administered Sonala-001 (10mg/kg), an IV formulation of 5-ALA...This first-in-human experience with a new therapeutic modality for recurrent glioblastoma patients demonstrates that 5-ALA SDT is safe at 200J. Sonodynamic therapy leads to targeted oxidative stress and tumor cell death in human glioblastoma tissue.
Clinical • P1 data
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CASP3 (Caspase 3)
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ALA sonodynamic therapy