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procedure

Targeted Osmotic Lysis

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Imagine a world where cancer did not cut short the lives of millions of people. Imagine a world where cancer treatment did not mean nausea and vomiting, hair loss and terrible pain -- did not mean nearly killing patients with radiation and chemotherapy in order to kill their cancer. Imagine a world where the very worst cancers of the liver, pancreas, breast, prostate, and brain could be treated through the use of existing generic drugs and the application of a gentle stimulus to the body. Imagine curing cancer in a few treatments, each lasting less than 15 minutes. Imagine turning the critical feature of cancer cells that enables their metastasis against them to blow them apart, while leaving the normal tissue around them untouched.

Over 1.6 million people contract epithelial cell cancer each year in the U.S. Forty percent of these cancers are considered to be "highly invasive" and over-express voltage-gated sodium channels (VGSCs). These cancers include, but are not limited to, highly invasive breast cancer, prostate cancer, small cell lung cancer, non-small cell lung carcinoma, lymphoma, neuroblastoma, cervical cancer, gliomas, neuromas, hepatic cancer, ovarian cancer, bladder cancer, pancreatic cancer, thyroid cancer, splenic cancer, stomach cancer, some skin cancers, testicular cancer, renal cancer, and oral cancers. More than 400,000 people die from epithelial cell carcinoma each year in the United States and an estimated 10 times that world-wide.

We believe that we have discovered a safe and effective treatment for highly malignant forms of cancer that is fundamentally different in principle and design than other methods and not likely to produce significant morbidity or discomfort. Targeted Osmotic Lysis (TOL) is a unique technology that takes advantage of the basic cellular mechanisms that enable cancer cells to more effectively metastasize, invade and proliferate in normal tissue.

Current approaches for treating cancer either chemically or physically alter cellular reproductive and supportive/restorative processes in an attempt to kill rapidly proliferating cells that invade and more effectively compete for nutrients and blood supply than the surrounding normal tissue. Unfortunately, traditional cancer treatments, e.g., chemo- and radiotherapy, simultaneously produce toxic effects on normal and abnormal tissues, thus presenting the clinician with the difficult challenge of trying to kill the neoplastic disease before killing the patient; a balance between treatment and rescue. Conversely, TOL disrupts the cancer cell's ability to maintain homeostatic balance. Excessive amounts of sodium ions are driven into cancer cells through sodium channels that are over-expressed in the cell membrane. The normal cellular process of pumping of sodium ions out is chemically blocked in the TOL process. With large amounts of sodium retained in the cell, water diffuses through the cell membrane into the cell, more than the cell can accommodate, resulting in the bursting of cancer cells just like an overfilled balloon. The basic cell mechanisms that are to be manipulated are present and essential for the functioning of all living organisms, both in humans and in non-human species and the treatment is administered using medications and physical technologies that have been approved and are already in clinical use for humans. Thus, the path to clinical use should be straightforward and the research timeline relatively short.

The basic research in the laboratories of Dennis Paul and Harry Gould at the LSU Health Sciences Center, both in tissue culture and in animal models, is well on the way to validate TOL's potential for success. The results for breast cancer: after one treatment in tissue culture, 100% of cancer cells were destroyed while none of the non-cancerous, normal cells were affected; in nude mice 80% of the cancer tumor cells were destroyed and the normal tissue was untouched. We have had similar dramatic results in tissue culture studies of colon, lung, and prostate cancers and lymphoma. Due to recent cuts in state support for the health science center, research funds for these studies are no longer available. Additional animal research needs to be performed before TOL can be tested in ex vivo studies to evaluate its effect on tumors removed from cancer patients as part of their comfort or palliative care. Once ex vivo research has been completed, we can begin clinical trials in patients with malignant epithelial-derived carcinomas including breast, lung and colon cancer. We are therefore seeking donations from a variety of sponsors to advance our basic science research that is a prerequisite for expediting clinical trials and obtaining regulatory approval of TOL for cancer treatment.

More than 400,000 people die from epithelial cell carcinoma each year in the United States and an estimated 10 times that world-wide. It is estimated that approximately 1.6 million new cancers will be diagnosed in 2014. The projected number of deaths attributable to cancer in the same time period is estimated to be 571,950; a rate of 1500/day.

Imagine the change this new treatment will make in the lives of millions of people. We are on the threshold of eradicating a significant portion of a disease that has plagued society for generations. The earlier we are able to introduce TOL into clinical practice, the sooner our loved ones will be saved from the ravages of this disease.

Poster Presentations

Presented at the American Society for Cell Biology Annual Meeting, December 2013

Related Papers

Paul, D. and H.J. Gould, III 2013 Targeted osmotic lysis of metastatic carcinomas by blockade of sodium pumps and stimulation of sodium channels. 2013 Meeting American Society for Cell Biology, New Orleans, LA, Abstracts.

Gould, H.J., III, G.P. Casey, and D. Paul 2011 Painful diabetic neuropathy: Current perspective on development and management from bench to bedside - A Review. In: V. Jacobs and A. Lang, eds. Analgesics: New Research, Nova Science Publishers, Hauppauge, NY., pp. 39-74.

Casey, G.P., D. Paul, and H.J. Gould, III 2010 Insulin is essential for the recovery from allodynia induced by complete Freund's adjuvant. Pain Med., 11:1401-1410.

Gould, H.J., III, R.D. Soignier, P. Nolan, L. Minor, Z.P. Liu, S.R. Levinson, and D. Paul 2004 Ibuprofen blocks changes in Nav 1.7 and 1.8 sodium channels associated with complete Freund's adjuvant-induced inflammation in rat. J. Pain, 5:270-280.

Gould, H.J., III, J.D. England, and D. Paul 2000 The modulation of sodium channels during inflammation. In: E. Krames and E. Reig, eds., Proc. Worldwide Pain Conference, Monduzzi Editore, International Proceedings Division, Bologna, Italy, pp. 27-34.

Gould, H.J., III, T.N. Gould, J. D. England, D. Paul, Z.P. Liu, and S.R. Levinson 2000 A possible role for nerve growth factor in the augmentation of sodium channels in models of chronic pain. Brain Res., 854:19-29.

Gould, H.J., III 2000 Complete Freund's adjuvant-induced hyperalgesia: A human perception. Pain, 85:301-303.

Gould, H.J., III, T.N. Gould, D. Paul, J. D. England, Z.P. Liu, S.C. Reeb, and S.R. Levinson 1999 Development of inflammatory hypersensitivity and the augmentation of sodium channels in rat dorsal root ganglia. Brain Res., 824: 296-299.

Gould, H.J., III, J.D. England, Z.P. Liu, and S.R. Levinson 1998 Sodium channel augmentation in response to inflammation induced by complete Freund's adjuvant. Brain Res., 802:69-74.

Gould, H.J., III, J.D. England, Z.P. Liu, and S.R. Levinson 1997 Sodium channel augmentation in response to pain induced by chronic inflammation. 16th Ann. Meeting American Pain Society, Abstracts, p. 99.


Oleander Medical Technologies
Louisiana Emerging Technology Center
340 East Parker Center, Baton Rouge, LA 70803
Phone: (225) 413-7658

Targeted Osmotic Lysis and TOL are trademarks of Oleander Medical Technologies.
International patents pending.