HEATT™ (Hyperthermia Extracorporeal Applied Tumor Therapy) & CoreHFC™

Breakthrough Treatment

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Using hyperthermia, or raising a patient’s temperature to 40-43°C (104-109.4°F), has been known for years to be cytotoxic (poisonous) to cancer cells in the body. It also has the added benefit of amplifying standard modes of treatment. Studies show that cells derived from solid organ tumors such as ovary, lung, pancreas, liver and kidney are susceptible to destruction by heat in the therapeutic range. We use this technique of creating a “super fever” via whole body hyperthermia. At the center of our treatment is the CoreHFC System. The CoreHFC System will incorporate state‐of-the‐art technology to deliver whole body hyperthermia effectively via our proprietary method. It will balance critical blood chemistries on a real time basis, a key to administering whole body hyperthermia safely.

Our whole body approach provides an advantage over other methods induced by external devices. It allows for a more homogenous heating of the body, recognized as very important in uniformly distributing therapeutic heat. With the controlled heating, potentially dangerous heat differentials are eliminated, allowing for a higher sustained temperature providing a better tumoricidal effect. We call this proprietary process Hyperthermia Extracorporeal Applied Tumor Therapy or HEATT.

History

Our lead scientist and cardiac perfusionist Dr. Roger Vertrees learned about a whole body hyperthermia circuit treatment for AIDS in the late 1990’s. These patients received two treatments at 42°C (107°F), four days apart with minimal side effects. The research was overshadowed by the effectiveness of combination drug therapy in AIDS treatment, eliminating the need for a technically complicated hyperthermia treatment. Furthermore, the early blood filtration element of the circuit was inefficient and difficult to manage. Despite these early filtration hurdles, the vascular shock (heat stroke) that stopped hyperthermia from becoming a mainstream option in cancer therapy was close to being solved. An elaborate research effort was undertaken at the University of Texas, Galveston. Multiple labs, combined with cell culture facilities, produced promising results proving the whole body hyperthermia circuit could be safely administered. This led to an FDA phase I trial for seven stage IV lung cancer patients, published in the Annals of Thoracic Surgery in 2004. These patients were treated with the same circuit used previously for AIDS. All patients survived the procedure and realized an improvement in both the quality of life and length of survival. This translated into a median survival of 450 days, whereas a conventionally-treated control group survived only 87 days. The FDA deemed a single treatment of systemic hyperthermia was safe, but a more comprehensive trial needed to be designed to prove effectiveness; with only seven patients, the results could be a (stunningly improbable) coincidence. Designing a more reliable filtration system was crucial and this would require additional funding. All of these important advancements, four years of lab work, cell culture work, and engineering design, came to an abrupt halt when Hurricane Ike destroyed Galveston Island, including Dr. Vertrees’ lab and facilities. The program was partially revived, but the economic collapse of 2009 negatively affected the future of the program. The group unfortunately parted ways, left the university, and Roger Vertrees retired to a ranch near Austin Texas, taking his research data with him.

A New Beginning

In 2006 Dr. James Lilja, partnering with Dr. Augusto Bastidas, began working with a regional hyperthermia treatment called HIPEC (Hyperthermic Intraperitoeal Chemotherapy). Learning of Dr. Vertrees research, attempts were made to contact the fragmented team to re-introduce this important technology and write the comprehensive trial needed to officially prove effectiveness to the FDA. Collaboration began in 2011 with an application to FDA to repeat the original trial, removing its inherent flaws. Test labs began in California, in collaboration with the FDA. In May of 2013, after significant, successful lab experimentation, we discovered a way to avoid circuit filtration issues that were problematic in the previous studies. We then received an official Investigator Device Exemption: this is a plan for exempting our team from FDA prohibitions to study the treatment in patients. We chose not to repeat a lung cancer trial, instead decided to treat ovarian cancer patients. Unlike the lung cancer patients, they have cardiovascular systems relatively unaffected by disease. Our goal is to prove that repeated treatments with hyperthermia are safe, and more importantly reproducible due to our whole body hyperthermia circuit innovations. We intend to further prove hyperthermia’s utility in multiple solid tumors, and build a shared central reference knowledge base for physicians. Another important goal is creating a Clinical Board for hyperthermia as we believe that once this technique is established as safe and reproducible, whole body hyperthermia will become the “fourth modality” in the treatment of cancer.

CoreHFC™

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The CoreHFC™, is a revival of several years of research which started with a hyperthermic AIDS/Kaposi sarcoma clinical trial treatment. This work evolved into a lung cancer clinical trial, and was then interrupted by (literally) a tidal wave in 2008 and brought to a halt with the economic collapse of 2009. Verthermia’s improved hyperthermia circuit, called HEATT™ (Hyperthermia Extracorporeal Applied Tumor Therapy), represents the current state-of-the-art technique of performing perfusion induced systemic hyperthermia or PISH. Unlike past designs, the CoreHFC™ circuit directs heated blood back into the venous vascular tree, balances blood chemistries and cleanses the blood of toxic byproducts noted with other circulatory hyperthermia techniques.