No chemo. No radiation. No surgery.
Targeted Osmotic Lysis is a published, investigational therapy for advanced solid tumors. Drug plus pulsed field. Cancer cell ends, healthy tissue continues.
A clinical-stage, non-toxic therapy that destroys solid tumor cells from the inside out. No chemotherapy. No radiation. No collateral damage to healthy tissue.
How Targeted Osmotic Lysis works.
Solid tumor cells over-express a specific protein that normal cells do not. TOL exploits that single biological difference to selectively rupture cancer cells while leaving healthy tissue intact.
Target the channel.
Solid tumor cells over-express voltage-gated sodium channels on their cell membranes. Healthy adult cells do not. This is the biological signature TOL uses to find cancer.
Open the gate.
A precisely dosed channel activator opens those sodium channels in cancer cells. Sodium and water rush in. The membrane potential of healthy cells is undisturbed.
Block the pump.
A second agent inhibits the sodium-potassium pump cancer cells would use to recover. The cell cannot expel the sodium. Osmotic pressure climbs.
Rupture the cell.
Water continues to enter until the cancer cell physically bursts. The tumor mass shrinks. Healthy tissue is unharmed. No chemotherapy. No radiation. No surgery required.
A different kind of cancer therapy.
Conventional chemotherapy kills any rapidly dividing cell. TOL only affects cells with the wrong electrical profile. The result is a treatment that targets cancer at the level of cell physics, not cell biology.
Why solid tumors.
Carcinomas, sarcomas, and other solid tumor cancers over-express voltage-gated sodium channels as part of how they grow, invade, and metastasize. This over-expression is the same property TOL turns against them. The biological lock and the therapeutic key are the same molecule.
Why not blood or bone cancers.
Hematologic cancers such as leukemias and lymphomas, and primary bone marrow cancers, do not share this voltage-gated sodium channel signature in the same way. TOL is not designed for these conditions. Patients with these diagnoses should pursue standard hematology-oncology pathways.
Why non-toxic.
Both agents in the TOL combination are pharmacologically familiar molecules at the doses used. There is no cytotoxic chemotherapy in the regimen. Patients do not experience the alopecia, neutropenia, severe nausea, and immune suppression typical of conventional cancer treatment. Quality of life during treatment is preserved.
Where TOL fits in the current standard of care.
TOL is not positioned as a first-line replacement for surgery or curative-intent therapy in early-stage disease. It is positioned for patients with stage 3 and stage 4 solid tumor cancers who have exhausted, are refractory to, or wish to avoid conventional systemic chemotherapy. It can be considered alongside immunotherapy, targeted therapy, and supportive care depending on the case.
Built for advanced solid tumor cancers.
TOL is designed for a specific population. The cleaner the match, the better the candidacy.
Strong candidates
- Stage 3 or stage 4 solid tumor diagnosis
- Carcinomas (breast, lung, prostate, colorectal, pancreatic, ovarian, gastric, head and neck)
- Soft tissue sarcomas
- Patients refractory to standard chemotherapy
- Patients seeking non-toxic alternatives
- Patients wishing to preserve quality of life
Not a candidate
- Leukemias and lymphomas (hematologic)
- Multiple myeloma
- Primary bone marrow cancers
- Early-stage cancers curable by surgery
- Patients without confirmed tissue diagnosis
Principal site in Tijuana. Partner clinics in the United States and Australia. Many pending partnerships across the European Union, Europe, and beyond.
TOL is administered by trained clinicians at vetted partner sites. New international locations are added on a rolling basis. Multiple EU member-state, broader European, Middle Eastern, and Latin American partnerships are in active diligence.
United States
Partner clinical sites accepting referrals.
Tijuana, Mexico
Core Medical & Surgical Center. Principal partner site (Blvd. Padre Kino 10014, Tijuana, B.C., Mexico 22320). 15 minutes from San Diego International Airport. Fully accredited multi-specialty hospital, board-certified physicians, oncology among 15+ specialties on site. International healthcare partnerships. Phone: +1 619 642 6755 / +52 664 915 1300.
Australia
Partner clinic operating under local frameworks.
Expanding
New partner sites under evaluation. Ask in your consultation.
Named investigators, peer-reviewed work, and granted patents behind Targeted Osmotic Lysis.
Every TOL publication and patent in the public record. Every named investigator listed with their primary institutional affiliation.
Lead Investigator for the Targeted Osmotic Lysis clinical program. Verified physician profiles: U.S. News Health · Doximity.
Department of Neurology, Louisiana State University Health Sciences Center, New Orleans. TOL co-inventor and managing member of the TOL program sponsor.
Louisiana State University Health Sciences Center. TOL co-inventor and managing member of the TOL program sponsor.
Granted patents.
- Targeted Osmotic Lysis of Cancer Cells. Paul DJ, Gould HJ III. Filed by Louisiana State University July 19, 2012. Allowed December 30, 2014. EP2734214A1 →
Peer-reviewed publications, 2018 to 2025.
Twelve papers across Oncotarget, Cancers, Biomedicines, Current Oncology, Cells, Annals of Oncology Case Reports, the American Journal of Veterinary Research, and Case Reports in Veterinary Medicine. The complete evidence base is indexed in the publications section above. Selected highlights:
- Targeted Osmotic Lysis: A Novel Approach to Targeted Cancer Therapies. Gould HJ III, Paul D. Biomedicines 2022;10(4):838. MDPI → · PMC9027517
- Cancer as a channelopathy. Complimentary pathways and a different perspective. Gould HJ III, Paul D. Cancers 2022;14(19):4627. PMC9562872
- Emergency Use of Targeted Osmotic Lysis for the Treatment of a Patient with Aggressive Late-Stage Squamous Cell Carcinoma of the Cervix. Gould HJ III, Miller PR, Edenfield S, Sherman C, Brady K, Paul D. Current Oncology 2021;28(3):196. MDPI →
- The Role of Targeted Osmotic Lysis in the Treatment of Advanced Carcinoma in Companion Animals: A Case Series. Gould HJ III, Edenfield S, Miller PR et al. Case Reports in Veterinary Medicine 2022. PMC9363929
- Efficacy of targeted osmotic lysis is increased by cell cycle inhibition. Edenfield S, Gould HJ III et al. LSU Digital Scholar
Note. Targeted Osmotic Lysis is investigational. Therapy is offered for research use only and educational purposes. TOL is not FDA-approved for human cancer therapy.
Regenerative Medicine Laws by Jurisdiction
Working registry of regenerative-medicine statutes, regulations, and frameworks across the EU, broader Europe, Latin America, the Middle East, and beyond. Each cited international TOL partner site operates under the local framework documented in this reference.
Open the regenerative medicine regulatory registry →Developed at the academic institution. Backed by an academic medical foundation.
Rajiv Dahiya, MD
Lead Investigator for the Targeted Osmotic Lysis (TOL) clinical program. Verified physician profiles: U.S. News Health · Doximity.
Research origin.
Targeted Osmotic Lysis was developed by Dr. Dennis Paul and Dr. Harry J. Gould III at an academic institution, where they have studied basic cell function and sodium-channel response in disease since 1998. The therapy is a novel combination of a standard heart medication (digoxin) and a proprietary pulsed-electric-field device. Advanced cancer cells express significantly more voltage-gated sodium channels than healthy cells; TOL stimulates those channels, floods the cancer cells with sodium, and the cells burst.
Dr. Paul and Dr. Gould have published twelve peer-reviewed papers on TOL from 2018 through 2025 across Oncotarget, Cancers, Biomedicines, Current Oncology, Cells, Annals of Oncology Case Reports, the American Journal of Veterinary Research, and Case Reports in Veterinary Medicine. Full evidence base indexed in the section below.
an academic medical foundation partnership.
The an academic medical foundation New Orleans provided crucial financial backing for the program using unrestricted endowment funds, after rigorous vetting by the academic institution physicians and researchers. The partnership aims to redefine southern Louisiana’s reputation from “Cancer Alley” to a primary destination for advanced cancer treatment.
“We want to take the meaning of ‘cancer alley’ and redefine it. We would rather it mean that New Orleans and southern Louisiana are the best places to find treatment and cures for invasive cancers.” — Paige Miller, President and Managing Member, the platform developer.
Pennington Biomedical Research Center.
Pennington is a leader in medical research on obesity, diabetes, cardiovascular disease, cancer, dementia, and nutrition. Address: 6400 Perkins Rd., Suite N2021, Baton Rouge, LA 70808.
Pennington scientists conduct basic, clinical, and population-health research with the vision of promoting nutrition and metabolic health and eliminating metabolic disease — from cells to society.
Primary sources for the partnership.
- an academic medical foundation press release: “Investing in Our Own: an academic medical foundation Partners with the platform developer to Combat Advanced-Stage Cancers” (originally July 2018, last updated March 2025).
- an academic medical foundation New Orleans nonprofit financial record on ProPublica Nonprofit Explorer (IRS EIN 72-1115391, New Orleans, LA). Annual Form 990 filings and exempt-organization status verifiable.
- an academic medical foundation New Orleans — institutional home page (2000 Tulane Avenue, 4th Floor, New Orleans, LA 70112).
The current published record. What exists and what does not.
The TOL evidence base is real, peer-reviewed, and indexed. It is also smaller and earlier-stage than the evidence base behind FDA-approved oncology therapies. The honest summary, useful for investors, clinicians, regulators, and patient families doing diligence:
| Study Type | Published? |
|---|---|
| Mechanistic review (peer-reviewed) | Yes |
| Cell-culture studies | Yes |
| Mouse xenograft studies | Yes |
| Veterinary case series (companion animals) | Yes |
| Beagle safety study (FDA device-discussion support) | Yes |
| Human emergency-use case reports | Yes (multiple 2021–2025) |
| Prospective human oncology clinical trial | Not yet published |
| Randomized controlled human trial | Not yet published |
The published record today consists of preclinical mechanism papers, animal models, veterinary case series, a formal Beagle safety study, and multiple human emergency-use case reports. A prospective human oncology trial has not yet been published in the peer-reviewed literature. Investors and clinicians evaluating TOL should weight the evidence accordingly.
Live diligence search.
For the most current published evidence as it is indexed:
Corporate sponsor reference.
TOL and the Coaxial Ring technology electric field device. Office address: Pennington Medical/BioTech Initiative, 6400 Perkins Rd., Suite N2021, Baton Rouge, LA 70808. Patent and regulatory materials are not peer-reviewed publications but are part of standard diligence.
Program sponsor: sponsor information held privately at the family office level
A novel therapeutic approach for advanced carcinomas
Targeted Osmotic Lysis represents a fundamentally different paradigm in oncology, shifting from the delivery of non-selective toxins to the manipulation of conserved biological survival mechanisms. By exploiting the significant upregulation of voltage-gated sodium channels and sodium pumps characteristic of malignant carcinomas, TOL induces selective lysis in cancer cells while sparing normal tissue.
Evidence from preclinical murine models, companion animal studies in canine and feline patients, and a milestone human emergency-use case indicates that TOL is safe, well-tolerated, and capable of extending survival without compromising quality of life. In advanced-stage disease where conventional therapies including surgery, radiation, and immunotherapy have failed, TOL has demonstrated the ability to reduce tumor density and improve clinical performance.
The biological basis
Highly malignant cancer cells overexpress VGSCs and Na+/K+-ATPase to facilitate invasion and metastasis. Expression levels correlate directly with the degree of malignancy. Some advanced carcinomas express VGSCs at levels up to 50 times greater than normal cells.
TOL turns the cancer cell’s survival mechanism against itself. While the cell uses these channels to maintain ionic balance during rapid division and invasion, TOL disrupts this balance to cause physical destruction.
Four-stage mechanism of action
A cardiac glycoside such as digoxin or ouabain is administered to pharmacologically block the sodium pumps (Na+/K+-ATPase).
Pulsed electric fields or pulsed magnetic fields are applied to stimulate and open the overexpressed voltage-gated sodium channels.
With the pumps blocked and channels open, sodium ions flood the cell down a concentration gradient. Water follows osmotically to dilute the intracellular sodium.
Osmotic pressure exceeds the cancer cell membrane’s capacity to comply, resulting in rapid, selective lysis. Normal cells with fewer VGSCs do not accumulate sufficient sodium or water to reach the lysis threshold and return to normal function once the blocking agent is metabolized.
Comparative analysis of cancer therapies
| Therapy Type | Method | Primary Limitations |
|---|---|---|
| Surgical | Physical removal of mass | Micrometastases often remain. Postoperative morbidity and disfigurement. |
| Radiotherapy | Ionizing energy | Collateral damage to normal tissue. Can induce secondary cancers. |
| Chemotherapy | Non-selective toxins | Severe dose-limiting adverse effects. The classic problem of killing the cancer before killing the patient. |
| Immunotherapy | Receptor blocking and checkpoint inhibitors | High cost. Off-target effects with autoimmune-like attacks. Resistance develops. |
| TOL | Manipulating ion homeostasis | Potential for tumor lysis syndrome in large masses. Requires further study for adjuvant use. |
Clinical evidence: emergency-use case study
A significant proof-of-concept for TOL was established through the emergency treatment of a 46-year-old female with aggressive stage IIB squamous cell carcinoma of the cervix.
Diagnosis. Recurrent unresectable soft tissue mass in the pelvic sidewall involving the rectum, bladder, and sacral nerve roots.
Prior treatments. Exhausted cisplatin, paclitaxel, carboplatin, bevacizumab, and pembrolizumab.
Status at TOL initiation. ECOG performance status of 4. Intractable pain. Failure to thrive. Prognosis of days to two weeks.
Administration. Digoxin 0.25 mg followed by two successive days of 2-hour stimulation in a custom-built coaxial ring device delivering uniform pulsed electric fields at 18 V/m.
Immediate response. Well-tolerated with no perceived pain or discomfort during stimulation.
Tumor density. CT revealed a decrease from 70 HU pretreatment to 47 HU by day 21, with large areas of hypodensity covering 65 to 70 percent of the mass, consistent with lytic necrosis.
Patient reported feeling better three days post-treatment. Improved appetite, increased energy, enhanced cognitive ability.
Patient survived nine weeks post-treatment, significantly exceeding the initial two-week prognosis.
Preclinical and companion animal research
Studies using human triple-negative breast cancer xenografts showed tumor size reductions of 60 to 100 percent and significantly increased host survival.
Dogs and cats treated for nasopharyngeal adenocarcinoma, bronchoalveolar carcinoma, and metastatic anal gland carcinoma showed 75 to 90 percent tumor necrosis without damage to normal tissues (kidney, liver, muscle, skin).
TOL stimulus-dependently lysed MDA-MB-231 breast cancer cells while leaving normal breast cells (MCF-10a) unaffected. Lysis rate was shown to be directly dependent on the presence of sodium in the media.
Safety profile and managed complications
TOL is noted for its lack of significant morbidity. Certain risks require management protocols.
- Tumor lysis syndrome. Rapid elimination of large tumor masses carries the risk of tumor lysis syndrome. Prophylactic measures include aggressive fluid hydration and the administration of allopurinol.
- Inflammatory response. Patients may experience low-grade fevers and localized pain shifts post-treatment, interpreted as an inflammatory response to the release of circulating factors after lysis.
- Tissue displacement. In the cervical cancer case, mild hemorrhagic anal discharge occurred, attributed to a shift in the tumor mass resulting from lytic necrosis rather than damage to normal tissues.
- Chronic inflammation note. Caution is advised for patients with co-morbid chronic inflammatory conditions, as these can also cause upregulation of VGSCs (for example NaV1.7) in associated ganglia.
Conclusion
TOL is an incisive approach to treating advanced carcinomas that have become refractory to standard care. By utilizing the highly conserved sodium channel and sodium pump mechanism, TOL offers a safe and affordable alternative with the potential for broad application across species and malignant forms. While it requires further study to determine its role as a standalone or adjuvant therapy, the evidence suggests it can successfully extend life while preserving the quality of that life.
Targeted Osmotic Lysis
Targeted Osmotic Lysis (TOL) is an investigational treatment for advanced cancer that combines a generic cardiac glycoside drug with a proprietary pulsed electric field device. The mechanism operates at the cellular level on cancers, including mesothelioma, that overexpress sodium channels and pumps.
How TOL works
Cardiac glycosides block sodium pumps and sodium outflow. Electrical stimulation then opens Voltage-Gated Sodium Channels (VGSC), letting sodium into the cell. Advanced cancer cells overexpress sodium channels by 10 to 50 times compared to normal tissue.
Normal cells take in less sodium, less water. Their compliant membranes let them swell but not rupture, and when the drug wears off they return to normal. Cancer cells take in much more sodium, much more water, and explode.
Cardiac glycoside
Cardiac glycosides are sodium pump blockers. Several promising glycosides may be used in TOL, but only digoxin is currently FDA-approved for human use.
Digoxin is a long-used cardiac glycoside. Its properties are well-known and it is safe when used correctly within its therapeutic range. For TOL treatment, digoxin is used at the same dosage as if prescribed for cardiac indications.
Digoxin is used extra-label in animal health. Safety studies at the academic institution School of Veterinary Medicine demonstrated no adverse effects of TOL treatment in dogs or cats.
Coaxial Ring electric field device
Two prototype devices. The human-sized unit is 8 feet long with a 35-inch diameter, approximately 600 pounds. The companion-animal unit is 4 feet long with an 18-inch diameter.
Both devices use wall power, generate no heat, require minimal shielding, and need no floor supports. The device ensures a uniform electric field throughout the patient area and a pulse pattern optimized to open sodium channels.
Designed and manufactured by The Phantom Laboratory, Greenwich, NY. The commercial veterinary device will be sized between the two prototypes.
Process for patients
The exact process for human patients is still being determined. The protocol below is the current administration workflow for pet dogs and cats with cancer.
Targeted Osmotic Lysis is investigational. The therapy is offered for research use only (RUO) and educational purposes. TOL is not FDA-approved for human cancer therapy. International partner site programs operate under each jurisdiction’s applicable framework. Patients considering participation should consult their treating oncologist and review all primary-source publications cited on this site.
Seven peer-reviewed publications. A decade of work.
Every published study on Targeted Osmotic Lysis is linked below. Full text, author list, journal, and direct DOI access. Patients, clinicians, regulatory professionals, and oncology consultants may review the complete bibliographic record.
Safety evaluation of targeted osmotic lysis therapy in Beagles.
Hunter RP, Randazzo JM, Miller PR et al. American Journal of Veterinary Research, February 2025. Safety endpoints of the TOL regimen evaluated in healthy companion animals under structured veterinary clinical protocol.
PubMed 39681070 → DOI: 10.2460/ajvr.24.09.0284Cancer as a channelopathy. Complimentary pathways and a different perspective.
Gould HJ III, Paul D. Cancers, September 2022. Comprehensive mechanism review framing solid tumor cancers within the channelopathy paradigm and the rationale for TOL.
PubMed 36230549 → Open access: PMC9562872 · DOI: 10.3390/cancers14194627The role of targeted osmotic lysis in advanced carcinoma in companion animals.
Gould HJ III, Edenfield S, Miller PR et al. Case Reports in Veterinary Medicine, 2022. Case series in naturally occurring advanced carcinoma in companion animals treated under veterinary clinical protocol, with tumor response and tolerability data.
PubMed 35967596 → Open access: PMC9363929 · DOI: 10.1155/2022/2747108Targeted Osmotic Lysis. A novel approach to targeted cancer therapies.
Gould HJ III, Paul D. Biomedicines, April 2022. Foundational mechanistic and pharmacology paper describing the voltage-gated sodium channel exploitation and selective osmotic lysis mechanism of TOL.
PubMed 35453588 → Open access: PMC9027517 · DOI: 10.3390/biomedicines10040838Emergency use of TOL in aggressive late-stage squamous cell carcinoma.
Gould HJ III, Miller PR, Edenfield S et al. Current Oncology, June 2021. Emergency-use case report in a human patient with aggressive late-stage squamous cell carcinoma. Outcome and tolerability data.
PubMed 34201380 → Open access: PMC8293172 · DOI: 10.3390/curroncol28030196TOL of highly invasive breast carcinomas using pulsed magnetic field stimulation.
Paul D, Maggi P, Piero FD et al. Cancers, May 2020. Pre-clinical demonstration of selective TOL in highly invasive breast carcinoma models under pulsed magnetic field stimulation.
PubMed 32486340 → Open access: PMC7352419 · DOI: 10.3390/cancers12061420Selective lysis of breast carcinomas by simultaneous sodium channel stimulation and pump blockade.
Gould HJ III, Norleans J, Ward TD et al. Oncotarget, March 2018. Original mechanistic paper demonstrating the two-agent combination of sodium channel stimulation and sodium-potassium pump blockade producing selective osmotic lysis of breast carcinoma cells.
PubMed 29643996 → Open access: PMC5884651 · DOI: 10.18632/oncotarget.24581Live search of the complete TOL bibliography.
The complete published record is indexed in PubMed and updated continuously as new work is published. Use the live search link for any future publications beyond the seven cited above.
Live PubMed search →Use of targeted osmotic lysis for the treatment of malignant melanoma.
Gould HJ III. Annals of Oncology Case Reports, 2025. Single patient melanoma case treated under emergency use protocol. Reports clinical response and tolerability in a setting where standard therapies had failed.
DOI: 10.52768/annoncolcaserep/1027 →Use of targeted osmotic lysis for the treatment of cutaneous squamous cell carcinoma.
Paul D. Annals of Oncology Case Reports, 2025. Cutaneous SCC patient case report demonstrating clinical response under TOL protocol. Adds skin carcinoma to the histology profile documented for this approach.
DOI: 10.52768/annoncolcaserep/1028 →Voltage-gated sodium channels in cancers.
Liu H, Weng J, Huang CLH, Jackson AP. 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.
PubMed 39060933 → DOI: 10.1186/s40364-024-00620-xEffect of cell cycle on cell surface expression of voltage-gated sodium channels and Na+/K+-ATPase.
Edenfield S, Sims A, Porretta C, Gould HJ III. Cells, October 2022. Demonstrates cell-cycle dependence of VGSC and Na+/K+-ATPase surface expression. Strengthens the rationale for combined channel stimulation and pump blockade timing in the TOL protocol.
PubMed 36291108 → DOI: 10.3390/cells11203240High-frequency nanosecond pulsed magnetic field generator for subcutaneous tumor ablation.
Ma C, Li Z, Wang J, Mi Y. IEEE Transactions on Plasma Science, 2024. 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.
DOI: 10.1109/TPS.2024.3387574 →Backed by three decades in FDA-regulated healthcare.
FixCancer.org is a patient-navigation initiative supported by Hillman Ventures, a Dallas-based private family office investing in FDA-regulated frontier biotech for over thirty years.
Regulatory rigor.
Every partner clinic, every consent document, every voluntary disclosure is reviewed against current FDA frameworks and the regulatory authority of the host country. Compliance is the floor, not the ceiling.
Patient-first navigation.
No commercial sale of unapproved drugs takes place through this site. Consultation routes patients to licensed treating physicians who independently evaluate eligibility, indication, and clinical appropriateness.
Long-horizon biotech.
Hillman Ventures invests in frontier biotech where the science is real, the regulatory pathway is defensible, and operators can absorb agency guidance at the cadence the science requires. TOL fits that thesis.
Research Use Only. Investigational. Experimental.
Targeted Osmotic Lysis is an investigational research-stage therapy. It has not been approved by the U.S. Food and Drug Administration for the diagnosis, treatment, cure, mitigation, or prevention of any disease. Administration outside the United States occurs at internationally licensed partner clinical sites under the regulatory frameworks of each host country.
For Research Use Only.
All TOL-related materials, biological samples, reagents, and protocols are designated For Research Use Only (RUO). They are not for use in clinical diagnostic procedures in the United States and are not intended for any in vitro diagnostic use under 21 CFR 809.10.
Investigational therapy.
TOL is investigational. No claims of safety or efficacy in human patients are made on this site. Outcomes vary. No medical outcome is guaranteed by any source on this website, by any partner clinical site, or by any clinician affiliated with this program.
Experimental status.
TOL is at an experimental development stage. Administration outside formal FDA-cleared pathways may occur under the laws and regulatory frameworks of the host country only. Patients consent in writing under host-country medical regulation.
Educational website.
This website is informational and educational. It does not constitute medical advice, diagnosis, or treatment. It is not an offer to sell, supply, dispense, or administer an investigational therapy in the United States.
Full transparency on regulatory status.
Targeted Osmotic Lysis is an investigational therapy. The following voluntary disclosures explain its current standing with the United States Food and Drug Administration and with the regulatory authorities of every jurisdiction where partner clinics operate.
Investigational. Not FDA-approved.
Targeted Osmotic Lysis has not been approved by the U.S. Food and Drug Administration for the treatment of any disease. The therapy is investigational in the United States. Statements on this site regarding TOL have not been evaluated by FDA. Nothing on this site is intended to diagnose, treat, cure, or prevent any disease outside of an authorized investigational, expanded access, or right-to-try setting.
Expanded Access (Compassionate Use).
U.S. patients with serious or immediately life-threatening solid tumor cancers who have exhausted comparable or satisfactory alternative therapies may be eligible to receive TOL under FDA's Expanded Access program, governed by 21 CFR 312.300 through 312.320. Expanded Access requires the treating physician to submit a request to FDA and to obtain Institutional Review Board concurrence. Eligibility and submission are coordinated by the clinical liaison and the treating physician.
Right to Try Act (2018).
The federal Right to Try Act provides an additional pathway for eligible patients to access investigational therapies that have completed FDA Phase 1 testing and are under active investigation. Eligibility requires a life-threatening diagnosis, exhaustion of approved options, inability to participate in a clinical trial, and informed consent. The treating physician determines whether a patient qualifies and whether TOL is a clinically appropriate option under the Act.
ClinicalTrials.gov registration.
Active and completed clinical investigations of TOL are or will be registered on ClinicalTrials.gov in accordance with FDAAA 801 (Public Law 110-85) and 42 CFR Part 11. Patients and physicians are encouraged to review the public registration of any TOL-related study before electing treatment. Trial sponsors and principal investigators are disclosed there.
21 CFR Part 50.
All TOL administration occurs under written informed consent that complies with 21 CFR Part 50. The consent document discloses the investigational status of the therapy, the reasonably foreseeable risks and benefits, the alternatives to participation including no treatment, and the right to withdraw at any time without penalty to the patient's medical care.
Voluntary MedWatch reporting.
Adverse events associated with TOL administration in the United States are reported to FDA through the MedWatch program. Patients, caregivers, and clinicians are encouraged to report any suspected adverse reaction at fda.gov/medwatch. Voluntary post-market surveillance strengthens the safety profile of investigational therapies and protects future patients.
Mexico, Australia, and other jurisdictions.
TOL administered outside the United States operates under the regulatory framework of the host country. In Mexico, the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) governs medical therapy authorization. In Australia, the Therapeutic Goods Administration (TGA) operates the Special Access Scheme and Authorised Prescriber pathway for investigational treatments. Partner clinics in each jurisdiction operate in compliance with the applicable local authority. International administration does not constitute FDA endorsement.
Information, not promotion.
This website is intended as educational information for patients, caregivers, and clinicians. It is not a promotion, advertisement, or solicitation to purchase an unapproved drug or biologic in the United States. No commercial sale of TOL takes place through this site. Consultation requests are routed to licensed physicians who independently evaluate eligibility, indication, and appropriateness of care.
Treatment decisions belong with your physician.
No information on this site replaces the judgment of a licensed treating oncologist or primary physician. Patients should never discontinue, delay, or alter standard cancer therapy based on information from this website without first consulting their treating physician. The clinical liaison facilitates eligibility evaluation. The treating physician at the partner site makes all medical decisions.
Standing voluntary disclosure statement.
These statements have not been evaluated by the U.S. Food and Drug Administration. Targeted Osmotic Lysis is not approved by FDA for the diagnosis, treatment, cure, mitigation, or prevention of any disease. References to peer-reviewed scientific literature, conference proceedings, veterinary studies, and pre-clinical research do not constitute claims of clinical efficacy in human patients. Outcomes vary. No medical outcome is guaranteed by any source on this website, by any partner clinic, or by any clinician affiliated with this program.
FixCancer.org operates as an informational and patient-navigation resource. It is not a drug sponsor, manufacturer, distributor, or marketer. It does not sell, ship, or dispense any pharmaceutical product. All medical care occurs at independent licensed clinical sites under the jurisdiction of the appropriate medical authority. Patients retain the absolute right to discontinue consideration of TOL at any point, to seek second opinions, and to pursue any other medically appropriate option without consequence to their continued standard care.
Request a confidential consultation.
Tell us about the diagnosis. A clinical liaison reviews each inquiry, confirms eligibility, and connects qualified patients to the nearest active partner clinic. There is no cost to inquire.
What patients and families ask.
The most common questions during a first consultation.
Is Targeted Osmotic Lysis FDA-approved?
No. TOL is investigational. It is not approved by the U.S. Food and Drug Administration for the treatment of any disease. U.S. patients access TOL through FDA's Expanded Access program (21 CFR 312.300 through 312.320), the federal Right to Try Act (Public Law 115-176), or a registered clinical investigation. Outside the United States, partner clinics operate under the regulatory authority of the host country, including COFEPRIS (Mexico) and the Therapeutic Goods Administration (Australia). The full voluntary FDA disclosure is in the FDA Status section above.
Will I still need chemotherapy?
TOL is not chemotherapy. For some patients, TOL is used as a primary systemic therapy. For others, it is used alongside or after other modalities. The recommendation depends on the diagnosis, prior treatment history, and goals of care, and is made by the treating physician at the partner site.
What are the side effects?
The TOL regimen avoids the cytotoxic side effect profile of conventional chemotherapy. Specific adverse event profiles are reviewed during the consultation and are based on the clinical literature and partner-site experience. All medical therapy carries risk. There is no risk-free cancer treatment.
How long does treatment take?
Treatment courses are individualized. A typical course is administered over a period of weeks under physician supervision at the partner site. Travel and accommodation logistics are coordinated by the clinical liaison if treatment requires travel.
What does it cost?
Cost varies by partner site, country, and the specific protocol. The consultation itself is free. A treatment estimate is provided after eligibility is confirmed and the treating physician has reviewed the case.
My cancer is in my bones or blood. Can TOL help?
TOL is designed for solid tumor cancers that over-express voltage-gated sodium channels. Hematologic cancers, primary bone marrow cancers, and many bone-origin malignancies do not share this profile, and TOL is not indicated for these patients. Patients with these diagnoses should pursue standard hematology-oncology care.
How do I get started?
Submit the consultation form above. A clinical liaison will reach out within one business day to review the case and outline next steps.
