Mechanism overview
Targeted Osmotic Lysis combines a cardiac glycoside (Na+/K+ ATPase inhibitor) with a pulsed electric field device. The PEF activates the over-expressed voltage-gated sodium channels, driving rapid sodium and water influx. The cardiac glycoside blocks the Na+/K+ pump's compensatory efflux. Cancer cells, unable to expel sodium fast enough, undergo osmotic rupture. Normal cells, with sparse channel expression, recover when drug clears.
Eligibility considerations for soft tissue sarcoma
- Histologic confirmationBiopsy-confirmed soft tissue sarcoma with documented voltage-gated sodium channel expression by immunohistochemistry or qPCR.
- StageStage 3 or stage 4 disease, refractory to standard-of-care, is the typical clinical context.
- Performance statusECOG 0 to 2. Performance status drives ability to tolerate the device protocol.
- Cardiac historyNo active dysrhythmia. Baseline ECG and serum electrolytes required given the cardiac glycoside.
- Regulatory pathwayClinical trial, FDA Expanded Access (21 CFR 312 Subpart I), Right to Try Act, COFEPRIS partner site (Mexico), or TGA Special Access Scheme (Australia).
Evidence base
Stage IIB cervical squamous cell carcinoma. After exhaustion of cisplatin, paclitaxel, carboplatin, bevacizumab, and pembrolizumab, the patient received emergency-use TOL. Imaging at six weeks documented primary tumor density reduction from 70 to 47 Hounsfield units. The case grounds the human safety and signal data.
Pal-Ghosh R, et al. Targeted Osmotic Lysis in stage IIB cervical squamous cell carcinoma. Current Oncology 2021.
Stage 3 cutaneous malignant melanoma. Three TOL cycles at the GARM International Foundation Clinic in Roatan, Honduras. Complete resolution of the index lesion with no residual scarring. Published in Annals of Oncology Case Reports.
Documented TOL response in a cutaneous SCC patient at a partner clinical site. Adds histology breadth to the human evidence base.
Total published TOL evidence base: thirteen peer-reviewed publications, one foundational LSU patent, three published human case reports across three histologies (cervical SCC, cutaneous SCC, melanoma).
Where TOL was developed
Targeted Osmotic Lysis originated at Louisiana State University Health Sciences Center. The foundational patent was developed by the LSU research team. Translation to clinical-stage development is led by Oleander Medical Technologies, with research and education support from the LSU Health Foundation.
Submit records for mechanism eligibility review.
The clinical team at the partner sites reviews pathology, imaging, and treatment history. A clinician returns a written eligibility assessment within three to five business days.
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