+ How does TOL work?

TOL is a revolutionary treatment for advanced cancer that does not rely on surgery, chemotherapy, or radiation. It kills metastatic cancer cells by forcing them to take in sodium ions while blocking the cells from pumping the ions back out. The resulting buildup of sodium causes water to enter the cells through osmosis, swelling the cells until they explode. The animation video gives a short demonstration of how TOL works.

+ Why does TOL destroy cancer cells and not destroy normal cells?

This is the most common question about TOL. Metastatic cancer cells have many more sodium channels than normal cells do, which allows the cancer cells to amass much more sodium during TOL treatment. The cancer cells take in large amounts of sodium, then large amounts of water, and they swell and burst. The normal cells take in less sodium, and thus less water. They swell very little, and then return to normal. This process is explained best at the end of the animation.

+ Which stages of cancer does TOL work on?

By its nature, TOL works most effectively on advanced cancers. In the later stages of most cancers, cancer cells have 10 to 50 times more sodium channels than normal cells do. This differential is what allows TOL to destroy the cancer cells and not the normal cells (as shown in the animation). Earlier stage cancer cells are more like normal cells. A treatment that would destroy these early stage cancer cells would risk harming normal cells as well.

+ Isn't it unusual to find a treatment that works on advanced cancers?

Yes. Although several good treatments are available for early-stage cancers, currently no treatment has been found to be very effective on later stage cancers. Because TOL works better on later stage cancers than on earlier stage ones, it appears to be a paradigm shift in the way cancer can be treated.

+ Will TOL work on all types of cancer?

No, we believe that it will not work on sarcomas, some blood cancers, and some isolated carcinomas (for instance, melanoma). We have tested TOL in mice on breast cancer tumors with very favorable results (80% cell death with one treatment). We have treated small cell lung, prostate, colon, and pancreatic cancers in tissue culture and achieved 97-100% cell death with these cancers. We have also had positive results in tests on mesothelioma, in both mice and tissue culture. The overexpression of sodium channels in the metastatic cells of other carcinomas suggests that many of them will also respond to this treatment.

+ Humans are not the same as mice. Why do you think that the results you have achieved in tests on mice predict that the same results will be achieved when TOL is tested on human subjects?

Unlike many of the newer cancer treatments that target species-specific genetically-determined proteins, TOL is not genetically targeted. By contrast, TOL works on a basic cell mechanism that is essential for cell survival and is present in all animals. The overproduction of sodium channels in cancer cells is similar in both mice and humans. Since these biological mechanisms are the same, the results should be the same.

+ Why would treatment with TOL be better than treatment with current methods?

Current surgical techniques frequently produce significant disfiguration and must be followed by some course of radiation or chemotherapy. Current radiation and chemotherapy treatments kill both normal and cancerous tissue resulting in serious damage to the individual being treated. The challenge is to give a treatment strong enough to kill the cancer, but not kill the patient. The side effects of such treatments usually include weight loss, hair loss, severe nausea, vomiting, and pain. Studies to date show that TOL will have a minimal effect on normal tissue. The most likely side effect will be a mild fever for one to three days. In addition, TOL destroys metastatic cancers wherever they are located in the body. (See the answer to the next question.)

+ What if the metastatic cancer has spread to other parts of the body? Will it be too late to use TOL?

Unlike radiation or surgical procedures, TOL need not be targeted at sites of known disease. We believe that one of the most important aspects of TOL is that it will destroy metastatic cells wherever they are located. So long as the cancer cells overexpress sodium channels, those cells will be destroyed when their sodium pumps are blocked and their sodium channels are opened. To effectuate a treatment where the cancer has metastasized, a patient's whole body would need to be treated in a specially designed treatment device.

+ Does TOL involve the use of a new drug?

Almost all recent innovations in cancer therapy have involved the creation of a new drug targeted to a specific type of cancer. The path to regulatory approval for such treatments is usually very long and expensive. TOL is different. It is not genetically targeted and it does not involve a new drug. Instead, it involves the combination of a long-used, generic drug with stimulation from a new medical device. We believe that this fact combined with the fact that the treatment is for advanced disease where the current treatments are frequently ineffective is likely to make the path to regulatory approval shorter and less complicated than the path for approval of a new drug. (See the FDA's advisory on breakthrough devices.)

+ Is TOL patented?

The first U.S. patent for TOL was issued December 30, 2014 for Targeted Osmotic Lysis of Cancer Cells (patent no. 8,921,320) and a second patent was issued on May 23, 2023 for Targeted Osmotic Lysis of Malignant Cancer Cells Using Pulsed Magnetic Field Gradients (patent no. 11,554,292). Patents have also been approved in Australia, Canada, Japan, and issued by the European Patent Office and nationalized by the following countries: Finland, France, Germany, Ireland, Luxembourg, Monaco, the Netherlands, Sweden, Switzerland, and the United Kingdom.

+ Why is TOL not better known?

We have pursued this research without major grant funding and so it has taken time to do the experiments and replicate the results. We presented our first peer-reviewed preliminary observations at the American Society for Cell Biology in December, 2013. The first peer reviewed article on TOL was published in the scientific journal Oncotarget in 2018.

+ When will cancer patients be treated with TOL?

We are working under FDA guidance to do the preliminary safety work necessary before beginning human trials. If this goes well, the first human trials could begin in 2024.

+ How can I help?

If you would like to help support the research on TOL, please contact us.