Los Gatos, Calif. (Oct. 27, 2014) – In January, 2014 Verthermia, Inc. obtained clearance from FDA and began a Phase I clinical trial exploring the potential of whole body hyperthermia (WBH) as a standalone treatment for Stage III or IV ovarian cancer. The company has completed eight treatments as of October, 2014.
The use of heat (hyperthermia) to treat disease is not a new concept. The first documented application occurred in the late 1800’s. William B. Coley inoculated patients with soft tissue sarcomas with a known toxin that resulted in the patient developing a high body (fever range) temperature. He reported that this therapy did, in fact, eliminate tumors. This observation resulted in a huge body of literature examining the use of heat as a therapy for many diseases including cancer, syphilis, HIV, and hepatitis.
Currently, for patients with metastatic cancer, treatment options are radiation, chemotherapy, or surgery or a combination of these therapies. Localized hyperthermia to ablate tumors is becoming a more accepted therapy in the United States and Europe. But, whole body hyperthermia, the raising of the patient’s the entire body temperature, has stalled due to the ineffectiveness of radiant heat and the toxicity of older means of heating the blood via the vascular system. Verthermia believes they have achieved a technique of making WBH temperature control predictable and have a means of improved safety through blood filtration. Verthermia hopes to put WBH on the list of mainstream modalities for the treatment of metastatic cancers.
2014 Patient Treatment Summary
Three patients have undergone one or more cycles of WBH in 2014. The first patient underwent once cycle of WBH in January 2014. The patient was then re-treated by her San Ramon oncologist with the same chemotherapy agents that failed in December 2013. Remarkably, the patient’s tumor appears to have completely responded on an imaging study completed in October, 2014. The patient is fully functional, and back at work. The second patient was treated with one cycle and was discharged the first postoperative day. Unfortunately the patient then developed a fatal lung blood clot approximately one month after treatment that was unrelated to her therapy. An autopsy indicated more extensive disease than pre-treatment imaging indicated. A third patient has undergone 6 cycles of WBH, approximately one month apart for six consecutive months. The patient has a returned to full functioning capability with elimination of significant pain in the right leg that had been caused by the presence of her tumor. There was no evidence of liver, kidney, lung, heart, or neurologic injury.
This early experience suggests that WBH may play a role in treating patients that have failed traditional surgical, radiation and chemotherapy and that multiple WBH treatments may be given to a patient without serious side effects. Despite this promising early experience, additional clinical study is required to verify safety and efficacy.
Verthermia Inc. was formed in 2012 to further develop whole body hyperthermia as the fourth modality in the treatment of cancer. The company received FDA clearance to begin a Phase I ovarian cancer safety trial which began in January of this year. Utilizing its proprietary patent pending CoreHFC™ device, the company’s team of specialists in gynecologic & surgical oncology, nephrology, and perfusion serve as collaborators for the clinical trials and all subsequent clinical work.
To learn more about the Verthermia study, a patient or her physician may review the website (www.verthermia.com) or contact the Verthermia study research staff using the ClinicalTrials.gov identifier “NCT02093871.” The study is currently being conducted in San Jose, Calif.
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