BOULDER, Colo.--(BUSINESS WIRE)--Actium BioSystems disclosed today that its novel system platform, ACT, for selectively delivering controlled hyperthermia as an adjuvant to chemotherapy, has been validated via in vivo studies by two independent authorities, including Duke University Medical Center and a contract research facility. Actium is now preparing for safety and pharmacokinetic studies to support an application to the FDA for permission to commence First-In-Human clinical studies as soon as possible.
“Our technology has been validated by in vivo studies, and we are moving into clinical trials as soon as possible.”
The in vivo studies successfully demonstrated that Actium technology is able to selectively achieve therapeutic temperatures in the bladder using an intravesical (in the bladder) nanoparticle-mediated hyperthermia approach. It has been known for many 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.
The scientific literature on the efficacy of hyperthermia treatment is voluminous; numerous clinical studies have demonstrated hyperthermia can more than triple the efficacy of radiation therapy in select tumors without an increase in systemic 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 conventional hyperthermia technology that, due to inherent design limitations, has faced tremendous difficulties in producing optimal and consistent results cost-effectively. Now, there’s ACT...
“While the clinical benefits of combining heat (hyperthermia) and chemotherapy in treating bladder cancer are well-established, the big challenge has been how to deliver the heat without harming healthy tissue. Actium has developed a selective-heating technology, ACT, which is designed to be effective, simple to use and precise, with minimal heating of adjacent healthy tissue,” said Joe Tondu, President and CEO of Actium BioSystems.
“The fact is that there is a significant unmet clinical need for treating bladder cancer, which recurs in about 60% of patients within two years,” said Tondu, who has been touched by cancer many times. He watched his wife fight breast cancer. 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.”
About Hyperthermia and Actium Cancer Treatment (ACT)
Hyperthermia is the targeted application of elevated temperatures in cancerous regions to improve the efficacy of traditional treatments including chemotherapy. While hyperthermia is applicable to many cancer types, the first indication being developed by Actium is bladder cancer. In concert with standard chemotherapy, the ACT System is designed to elevate the cancerous region temperature by 30C to 50C above body ambient temperature (physician determined) using a proprietary computer-controlled algorithm. Generating a safe magnetic field, the ACT System together with iron oxide nanoparticles delivered via catheter as an intravesical ferrofluid operates as a treatment system. The magnetic field excites the nanoparticles, causing particle rotation and magnetic domain realignment, both generating heat. The ACT System is designed to precisely heat the magnetic nanoparticles to within a few tenths-of-degree accuracy. When hyperthermic temperatures are maintained in the 420C (107.60F) range and sustained for an hour, significant benefits are known to accrue that considerably advance the efficacy of chemotherapy.
CAUTION: The ACT system is not approved for sale in the United States.