Information notice. The literature catalogued below describes an investigational therapy. Publication of preclinical, case-report, and safety data does not constitute United States Food and Drug Administration determination that the therapy is safe or effective for any indication. See /regulatory for the investigational therapy statement.
Foundational patent
The patent of record establishing the underlying intellectual property.
Targeted Osmotic Lysis of Cancer Cells.
European Patent EP2734214A1. Filed by Louisiana State University on July 19, 2012. Allowed December 30, 2014.
The foundational patent describing combined stimulation of voltage-gated sodium channels and pharmacological blockade of sodium pumps to induce selective osmotic lysis of cancer cells.
Mechanism foundation
Papers establishing and validating the molecular and biophysical mechanism of TOL.
Selective lysis of breast carcinomas by simultaneous stimulation of sodium channels and blockade of sodium pumps.
Oncotarget 2018;9(21):15606–15615. doi:10.18632/oncotarget.24581. PMID 29643996.
Original mechanism paper demonstrating selective lysis of breast carcinoma cells through simultaneous voltage-gated sodium channel stimulation and sodium pump blockade.
Targeted Osmotic Lysis of Highly Invasive Breast Carcinomas Using Pulsed Magnetic Field Stimulation of Voltage-Gated Sodium Channels and Pharmacological Blockade of Sodium Pumps.
Cancers 2020;12(6):1420. doi:10.3390/cancers12061420. PMID 32486340.
Preclinical demonstration of the TOL approach in highly invasive breast carcinoma models using pulsed magnetic field stimulation.
Targeted Osmotic Lysis: A Novel Approach to Targeted Cancer Therapies.
Biomedicines 2022;10(4):838. doi:10.3390/biomedicines10040838. PMID 35453588.
Comprehensive review of TOL as a novel approach to targeted cancer therapy, integrating mechanism, preclinical data, and translational considerations.
Cancer as a Channelopathy: Appreciation of Complimentary Pathways Provides a Different Perspective for Developing Treatments.
Cancers 2022;14(19):4627. doi:10.3390/cancers14194627. PMID 36230549.
Conceptual paper framing cancer as a channelopathy and the implications for targeted therapy development.
Targeted Osmotic Lysis (TOL) Abstract R5215.
The FASEB Journal 2022;36(S1):R5215. Presented at Experimental Biology 2022.
FASEB Journal supplement abstract presenting Targeted Osmotic Lysis experimental data at Experimental Biology 2022.
Targeted Osmotic Lysis (TOL) Abstract R5089.
The FASEB Journal 2022;36(S1):R5089. Presented at Experimental Biology 2022.
Companion abstract to R5215, presenting additional Targeted Osmotic Lysis experimental data at Experimental Biology 2022.
Targeted Osmotic Lysis: FASEB 2019 Abstract.
The FASEB Journal 2019;33(1 Supplement):675.9. Presented at Experimental Biology 2019.
FASEB Journal supplement abstract presenting earlier-stage Targeted Osmotic Lysis preclinical results.
Efficacy of targeted osmotic lysis is increased by cell cycle inhibition.
Louisiana State University Health Sciences Center Digital Scholar archive.
Preclinical work showing that pairing TOL with cell cycle inhibition enhances tumor cell killing, suggesting a combination protocol pathway for advanced disease.
Human case reports
Published case reports describing administration of TOL in human patients under emergency-use protocols (Current Oncology, 2021) and under IRB-approved pilot studies at the GARM International Foundation Clinic, Roatan, Honduras (Annals of Oncology Case Reports, 2025).
Emergency Use of Targeted Osmotic Lysis for the Treatment of a Patient with Aggressive Late-Stage Squamous Cell Carcinoma of the Cervix.
Current Oncology 2021;28(3):2115–2122 (Article 196). doi:10.3390/curroncol28030196. PMID 34201380.
Emergency-use TOL administration in a 46-year-old female with stage IIB cervical squamous cell carcinoma demonstrating tumor density reduction from 70 to 47 Hounsfield units on follow-up imaging.
Use of Targeted Osmotic Lysis for the Treatment of Malignant Melanoma: Case Report.
Annals of Oncology Case Reports 2025;5(1):1027. Published online March 15, 2025. Open access (CC BY 4.0).
A 51-year-old male with stage 3 (pT3b) malignant melanoma, 2.1 mm thickness, level IV invasion, ulcerated, peripheral and deep margins positive, who declined Moh's microsurgical resection with sentinel lymph node biopsy. Pre-treatment biopsy confirmed voltage-gated sodium channel expression sufficient to indicate TOL eligibility. Treated under an IRB-approved pilot study (GARM #12132023) at the GARM International Foundation Clinic, Roatan, Honduras. Three weekly cycles of TOL, oral digoxin 0.25 mg daily titrated to a steady-state serum level of 0.9 mcg per L, with two hours of pulsed electric field stimulation on two consecutive days per cycle delivered through a coaxial ring device at 18 V per m. The report describes complete resolution of the primary lesion without residual scarring, MRI of the head, face and neck at five weeks showing no evidence of residual or metastatic disease, and no adverse events through six months of follow-up.
Use of Targeted Osmotic Lysis for the Treatment of Cutaneous Squamous Cell Carcinoma. Case Report.
Annals of Oncology Case Reports 2025. Published online. Open access (CC BY 4.0).
Human case report documenting TOL treatment of a cutaneous squamous cell carcinoma patient. Adds skin carcinoma to the histology profile documented for this approach.
Abstract 1071: Efficacy of Targeted Osmotic Lysis.
Cancer Research (American Association for Cancer Research) 2022;82(12 Supplement):1071. Presented at the AACR Annual Meeting 2022.
AACR-presented efficacy abstract on Targeted Osmotic Lysis as a treatment modality, summarizing the cumulative preclinical and translational results.
Veterinary studies
Companion animal studies establishing safety and translational signal in real-world tumor settings.
The Role of Targeted Osmotic Lysis in the Treatment of Advanced Carcinoma in Companion Animals: A Case Series.
Case Reports in Veterinary Medicine 2022;2022:2747108. doi:10.1155/2022/2747108. PMID 35967596.
Case series of advanced carcinoma in companion animals (dogs and cats) treated with TOL, reporting 75 to 90 percent tumor necrosis on follow-up.
Safety evaluation of targeted osmotic lysis therapy in Beagles.
American Journal of Veterinary Research February 2025;86(2). doi:10.2460/ajvr.24.09.0284. PMID 39681070.
Structured safety study of TOL therapy in healthy Beagles evaluating cardiovascular, hematologic, and clinical chemistry endpoints under formal veterinary clinical protocol.
Independent supporting literature
Third-party research validating the mechanism rationale and the broader engineering interest in pulsed field oncology.
Voltage-gated sodium channels in cancers.
Biomarker Research July 2024.
Independent comprehensive review of voltage-gated sodium channel expression across human cancers. Supports the foundational premise that VGSC overexpression marks malignancy and represents a therapeutic target.
Stacked spiral coil for nanosecond pulsed magnetic field generation for in vivo tumor ablation.
IEEE Transactions on Plasma Science 2024. doi:10.1109/TPS.2024.3387574.
Independent engineering work on a stacked spiral coil device producing nanosecond pulsed magnetic fields for in vivo tumor ablation. Validates the broader research interest in pulsed electromagnetic field oncology engineering parallel to the TOL coaxial ring device.
Comprehensive white paper
A single fourteen-page document consolidating the biophysics, the immune-engineering framing, the mechanism walk-through, and the published clinical evidence.
Targeted Osmotic Lysis (TOL): A Novel Therapeutic Approach for Advanced Carcinomas.
Biophysics and immune-engineering framing, mechanism of action across four stages, comparative analysis vs. surgery / radiation / chemo / immunotherapy, the cervical SCC emergency-use case in full clinical detail (ECOG 4, exhausted cisplatin / paclitaxel / carboplatin / bevacizumab / pembrolizumab, 18 V/m coaxial ring device, 70 to 47 HU tumor density, nine-week survival vs two-week prognosis), preclinical murine and companion animal data, safety and tumor-lysis-syndrome management.
The Aggression Paradox: Turning Cancer's Survival Mechanism Into Its Vulnerability.
Companion white paper. Frames the central biological paradox underlying TOL: the same VGSC over-expression that powers tumor invasion and metastasis is the structural feature that makes the cell vulnerable to selective osmotic lysis.
Targeted Osmotic Lysis (TOL) and the Role of Digoxin in Oncology. Comprehensive Briefing.
Mechanism, the specific role of digoxin in oncology (CTC cluster dissolution, TOL synergy, augmentation with imiquimod), veterinary milestones (Marley, Dodge, Otto, Gizmo), human case studies (Case SS melanoma, Case DP SCC, 2025 metastatic breast cancer study with nine patients), treatment protocol, and current jurisdictional access (Roatan in Honduras, Tijuana in Mexico, Australia).
Request a literature pack
The intake team provides full-text PDFs of the publications above (where copyright permits), supporting protocol documents, and the technical handout for treating clinicians on request. Email intake@fixcancers.com with subject line "Literature pack request."
For the canonical evidence section maintained on the technical sister site, with the press kit and downloadable materials, see fixcancer.org/literature.
WO2013012997 — Targeted Osmotic Lysis of Cancer Cells (International Filing).
World Intellectual Property Organization international patent publication. Companion to the U.S. patent application 13/552,909 allowed December 30, 2014.
International Patent Cooperation Treaty (PCT) filing covering the Targeted Osmotic Lysis method for selective cancer-cell rupture through combined cardiac glycoside blockade and pulsed electric field activation of voltage-gated sodium channels.
U.S. Patent 11,654,292 — Targeted Osmotic Lysis (continuation/extension).
United States Patent and Trademark Office, granted patent No. 11,654,292.
Granted U.S. patent covering Targeted Osmotic Lysis methods. Companion to the original LSU foundational patent and the WIPO international filing.
Targeted Osmotic Lysis Device Engineering Abstract.
American Association of Physicists in Medicine Annual Meeting 2017. Abstract ID 35818.
AAPM Annual Meeting abstract documenting medical-physics engineering of the Coaxial Ring pulsed electric field device for Targeted Osmotic Lysis.
Targeted Osmotic Lysis Research Poster (Arnaud-Lester).
LSU Health Sciences Center, Department of Genetics, 2021 research poster.
Academic research poster from LSU Health Sciences Center documenting Targeted Osmotic Lysis investigations at the institutional research level.
Exploring TOL Cancer Therapy in Honduras.
Independent press coverage of Targeted Osmotic Lysis treatment access at the GARM International Foundation Clinic in Roatan, Honduras.
Independent journalism on TOL cancer therapy and the Honduras-based partner clinical site.
Independent press & media coverage
Selected independent press articles, videos, and institutional announcements documenting Targeted Osmotic Lysis development.
Google: Cure for Cancer.
Baton Rouge press coverage documenting TOL as a candidate cancer-treatment technology.
The Other Side of Cancer Alley.
New Orleans press coverage of TOL research, framing the cancer-cluster geography of Louisiana and parallel non-toxic-therapy research.
Even the Dead Are Vain — Happy Hour.
Earlier New Orleans press coverage from the same outlet documenting TOL research development.
Targeted Osmotic Lysis — Video Presentation.
Video presentation hosted on Vimeo documenting Targeted Osmotic Lysis research.
LSU Health Foundation Announces Strategic Investment.
LSU Health Foundation institutional announcement of a strategic investment in Targeted Osmotic Lysis development.