Treatment Options are Available

Procedure

Targeted Osmotic Lysis (TOL) is a revolutionary treatment for advanced cancer, combining a generic drug (a cardiac glycoside) with a proprietary pulsed electric field device.

Simple TOL animation

TOL operates at the cellular level on cancers (most cancers, mesothelioma) that overexpress sodium channels and pumps. We can block sodium pumps and sodium outflow using a cardiac glycoside. Then we electrically stimulate to open Voltage Gated Sodium Channels (VGSC), letting sodium into the cell. Because advanced cancer cells overexpress sodium channels by 10-50 times compared to normal tissue, normal cells take in less sodium, less water, and their compliant membranes let them swell but not rupture; when the drug wears off they return to normal. Cancer cells take in much more sodium, much more water, and explode.

About the drug

Cardiac glycosides are sodium pump blockers.

  • There are several other promising cardiac glycosides to use in TOL that might be more selective for different sodium pumps and may be used at a later time, but only digoxin is currently FDA-approved for human use. 

  • Digoxin is used extra-label in animal health.

Digoxin is a long-used cardiac glycoside. Its properties are well-known and it is safe when used correctly.

  • Digoxin has a narrow therapeutic range and its safety profile is considered acceptable when used within that therapeutic range.

  • For TOL treatment, digoxin is used in the same dosage as if it were being prescribed for cardiac treatment.

About the electrical device

Coaxial Ring electric field device:

  • Prototype device at left is 8’ long with a 35” diameter. ~600 lbs., sized for human patients.

  • Prototype device at right is 4’ long with an 18” diameter, shown here treating mice.

  • Both devices use wall power, generate no heat, require minimal shielding and no floor supports.

  • Device ensures a nearly uniform low amplitude, low frequency electric field throughout the patient area and a pulse pattern optimized to open sodium channels.

  • Designed and manufactured by The Phantom Laboratory in Greenwich, NY.

A more detailed description of this case may be found here Source >

Process for patients

The process for TOL patients is still currently being defined, but this is how TOL is currently administered.

1 – Diagnose, image & dose

Take and fix biopsy, assay for overexpression of sodium channels. If candidate is suitable, image tumor and begin dosing drug orally 6 days pre-treatment.

2 – Treat in the device

Place patient in device, no sedation or restraints needed. Treat for 2 hours on the first day and 2 hours on the second day, with a break as needed.

3 – Gather data/treat again

Obtain post treatment metrics including quality of life and disease response. Plan additional courses of treatment as indicated.

None of our human cancer patients have exhibited serious adverse events

Many have seen significant tumor shrinkage