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WHAT IF there were a way to give cancer a ‘fever’ to enhance the results of chemotherapy and radiation? There is, says Actium BioSystems…

It has been known for years that heat weakens and kills cancer. But heat also affects normal, healthy tissue the same as cancer cells. Except that low-temperature heat, from the normal body temperature of 37⁰C (98.6⁰F) to less than about 42⁰C, has little effect on healthy tissue, but can weaken and kill cancer cells. This is the basic concept of treating cancer with low-temperature heat, called hyperthermia.

Indeed, the scientific literature on the efficacy of hyperthermia treatment is voluminous; numerous 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, providing a safe and effective treatment for many types of solid tumors.

Unfortunately, these clinical outcomes were achieved using current hyperthermia technology that, due to inherent design limitations, has faced tremendous difficulties in producing optimal and consistent results cost-effectively.

Now, there’s ACT: Actium Cancer Treatment, which is designed to increase the ability of standard-of-care chemotherapy drugs to penetrate deeper into cancer tumors and to deliver more drug, thereby increasing the chemo’s efficacy.

For example, bladder cancer recurs in about 60% of patients within two years, and the treatment procedure must be repeated. In some cases it has to be treated a dozen times over a period that can exceed 15 years.

Physicians have known for decades that delivering more drug to most diseases increases efficacy. But systemic toxicities are typically dose-restricting. By gently heating the bladder during the standard soaking of the bladder with chemotherapy, more drug is delivered to the cancer, killing more of it. The problem has been that the available technology to selectively heat tissue is unacceptable for most uses.

The Actium Cancer Treatment (‘ACT’) System is designed to solve this problem. It consists of a proprietary AC magnetic-field generator that illuminates iron oxide nanoparticles in, or near, the tumor with a sophisticated real-time feedback loop computer control that delivers precise heat to cancer tumors. In combination with radiation, chemotherapy, or immunotherapy, the ACT System’s controlled heat has the potential to substantially increase the efficacy of these traditional treatments.

There are more than 2.5 million intravesical bladder cancer treatments performed in the U.S. every year, making bladder cancer the most expensive cancer to treat per patient over a patient’s lifetime. Actium estimates that use of the ACT System bladder cancer treatment has the potential to save more than $1 billion annually.

Today, patients have limited options for treatment of bladder cancer. Pharma companies with promising pipeline chemotherapeutic candidates stand to benefit from a large unmet need and gain a larger share of the bladder cancer therapeutics market by partnering with Actium.

The therapeutic value of hyperthermia has been demonstrated in clinical trials, but existing hyperthermia delivery technology has been a huge impediment: crude, difficult to operate, expensive, with deleterious side effects. The ACT System has numerous competitive advantages.

Actium has demonstrated proof-of-concept of the ACT System in small-animal studies conducted by Duke University as well as large-animal studies conducted at a contract research facility in Colorado. Actium expects to commence early-stage human clinical studies in 2013.

Actium’s CEO Joe Tondu has been touched by cancer many times. He has watched his wife fight breast cancer, which has been in remission for the past 10 years. And he has watched his father, aunts, uncles, cousins, friends, neighbors, and longtime family friend and business partner succumb to cancer.

“The ACT System is designed to solve the selective-heating problem by exciting only magnetic nanoparticles to the precise temperature needed to increase the efficacy of traditional cancer treatments,” says Tondu. “Our technology has been validated by in vivo studies, and we are moving into clinical trials as soon as possible,” says Tondu, who has invested millions of his own money to develop the ACT technology.

“While the clinical benefits of hyperthermia in treating bladder cancer are well-established, the challenge has been how to administer the heat treatment selectively, consistently and cost-effectively,” says Tondu. “There is a desperate need for new treatment options for cancer. We identified bladder cancer as an ideal initial candidate for ACT, as the advantages of using heat are well-known in treating bladder cancer.  The problem is that no one has been able to figure out how to deliver the heat selectively. Our technology is designed to heat the bladder and do it in a safe and effective manner.  Once that is done we will move on to other cancer targets,” Tondu says.