Hyperthermia is the gentle heating of tissue below ablation temperatures, typically less than 5° C above normal body temperature. Clinical studies have demonstrated hyperthermia can more than double the efficacy of radiation therapy in select tumors, without an increase in toxicity, and can enhance the efficacy of a number of chemotherapeutic agents for many types of solid tumors.
These reported outcomes are impressive, but they were achieved using the current hyperthermia technology, which has limited application, is expensive, difficult to use, and often has unacceptable side effects.
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Bladder Cancer is divided into two general groups depending on if the cancer has penetrated the muscle layer of the bladder. Superficial bladder cancer that has not penetrated the muscle layer is referred to as “non-muscle invasive bladder cancer” or “MNIBC.”
There are approximately 600,000 people in the US diagnosed with bladder cancer with over 73,000 newly diagnosed and 14,000 deaths in 2012. For NMIBC the standard of care treatment is the surgical removal of the tumor through the urethra and depending on the stage, grade, and health of the patient the surgery is followed by intravesical (in the bladder delivered via catheter) immunotherapy (BCG) or chemotherapy. In cases where the patient is at high risk of advancing to muscle invasive cancer the bladder may be removed through an operation called a cystectomy.
Bladder cancer reoccurs up to 60% of the time within two years. When the disease reoccurs, it has to be treated as many as a dozen times over a period that can exceed 15 years. Because of the long survival time and the repeated treatments, bladder cancer has the highest lifetime costs to treat, with some estimates exceeding $174,000 per patient.
ACTIUM’S BLADDER CANCER TREATMENT “ACT”
The Actium Hyperthermia Device is being designed to deliver highly precise heat exclusively to the bladder to enhance the efficacy of mitomycin C (MMC) in treating NMIBC. This device is comprised of four integrated components; the external Magnetic Field Generator, the Delivery Catheter, a Ferrofluid for energy conversion, and the Control System.
In clinical trials conducted in Europe, hyperthermia when added to standard MMC treatment of NMIBC has demonstrated as much as a 38% reduction in tumor recurrence.
SMALL ANIMAL RESEARCH
In early 2012, an Actium Hyperthermia Device designed for small animal research was installed at Duke University under the direction of Dr. Mark Dewhirst to test the ability to heat rat bladders. Numerous successful tests were conducted that selectively heated the rat bladder.
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small animal treatment machine
PROOF OF CONCEPT:
LARGE ANIMAL DISCOVERY STUDIES
Actium recently performed a number of animal studies using female pigs to verify the performance of our human-scale system.
These studies have clearly demonstrate the ability of the Actium Hyperthermia Device to heat the bladder in a highly controlled fashion to within one tenth of a degree C and hold it at the designated temperature for 60 minutes.
These experiments were successfully repeated in five consecutive pig tests.
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